AS9110 Lead Auditor Training (Rev C) with ISO 9001:2015

Probitas Certified Lead Auditor Live-Online Training Course

Days: 5 • CEU Hours: 4.75

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
Days 1-4: 7:30 AM – 6:30 PM MST
Day 5: 7:30 AM – 11:00 AM MST
This course is certified by Probitas Authentication.  Successful completion of this course satisfies the AS9110 Lead Auditor training requirement for Aerospace Auditor authentication.

Even though AS9110 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

In addition to this course, aerospace auditors must also complete the IAQG sanctioned Aerospace Auditor Transition Training course to fulfill the training requirements for aerospace auditor authentication and recognition in OASIS.

 

Overview

Organizations in the aerospace maintenance, repair, and overhaul (MRO) industry face unique quality requirements, and effective auditing is essential for maintaining compliance, managing risk, and ensuring safety. AS9110 builds on ISO 9001 by adding MRO-specific requirements that must be clearly understood and properly assessed during audits.

This interactive, live-online AS9110 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits to both AS9110C and ISO 9001:2015 standards. Certified by Probitas, this course fulfills the formal training requirement for AS9110 Lead Auditors.

Led by experienced instructors, you will explore every phase of the audit process, including:

  • Understanding ISO 9001 and AS9110 requirements
  • Planning, scheduling, and preparing for audits
  • Conducting effective opening and closing meetings
  • Interviewing auditees using proven questioning techniques
  • Reviewing documents, processes, and records for compliance
  • Identifying nonconformities and writing audit findings
  • Following up with corrective actions and verifying effectiveness

This course emphasizes hands-on learning through interactive activities, group discussions, case studies, real-world scenarios, and role-playing exercises. Whether you are auditing internal processes, suppliers, or regulatory compliance, you will gain the confidence, knowledge, and tools needed to perform high-quality audits in MRO and aerospace service environments. You will also leave with a practical, structured, and repeatable approach to auditing that supports long-term success.

Pre-Requisites

Students will need to complete assignments before the start of class, including reading the standard.

This AS9110 Lead Auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own copy of the AS9110 RevC standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9110 lead auditor training - Men standing around nose of airplane

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Quality Control and Quality Assurance Personnel
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Those who perform Supplier Audits
  • Operational Auditors

 

AS9110 Lead Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the AS9110:2016 Rev C requirements.
  3. Develop the knowledge and skills required to become a Lead Auditor.
  4. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  5. Apply the proper interpretation of the standard in actual audit situations.`
  6. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  7. Follow-up and resolve audit trails that present themselves during the audit interviews.
  8. Conduct audits that result in real improvements to the quality system.
  9. Conform to the auditing practices outlined in ISO 19011, ISO 9001, AS9110, and AS9101.
  10. Fulfill the lead auditor training requirements of the IAQG Certified Lead Auditor program.

 


Related Courses 

AS9100 Rev D Lead Auditor Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

AS9110 Internal Auditor Training (Rev C) with ISO 9001:2015

Probitas Certified Internal Auditor Live-Online Training Course

Days: 3 • CEU Hours: 2.4

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
7:30 AM – 6:30 PM MST
Axeon Inc. is certified by Probitas Authentication and is an IAQG recognized Training Provider for the AS9110 Lead Auditor Training Class. This AS9110 Internal Auditor Class is certified by Axeon, Inc.

 

Overview

Organizations in the aerospace maintenance, repair, and overhaul (MRO) industry operate in an environment where safety, airworthiness, and regulatory compliance are non-negotiable. Internal audits are not just a requirement, they are a critical tool for managing risk, preventing escapes, and strengthening operational control. AS9110 builds on ISO 9001 by adding MRO-specific requirements that must be clearly understood, correctly interpreted, and effectively audited to ensure your Quality Management System truly supports safe and reliable operations.

This interactive, live-online AS9110 Internal Auditor Training is designed to prepare you to confidently conduct internal audits to AS9110:2016 Rev C. Delivered by an IAQG-recognized training provider through Probitas Authentication, this course focuses on building real-world auditing competence, not just theoretical knowledge.

Led by experienced aerospace auditors, this practical 3-day course walks you through every phase of the internal audit process, including:

  • Understanding and interpreting AS9110:2016 Rev C requirements
  • Planning and preparing for internal audits
  • Conducting effective opening and closing meetings
  • Interviewing auditees using proven questioning techniques
  • Reviewing documents, processes, and records for conformity
  • Identifying nonconformities and writing clear audit findings
  • Following audit trails and evaluating corrective actions

Unlike academic programs that emphasize abstract quality theory, this course is hands-on and application-driven. Through case studies, group discussions, real-world scenarios, quizzes, and role-playing exercises, you will actively practice the skills needed to perform effective internal audits in MRO and aerospace service environments.

By the end of the course, you will be prepared to conduct a structured, thorough, and value-added internal audit that not only verifies compliance, but drives meaningful improvement within your Quality Management System.

Pre-Requisites

Students will need to complete assignments before the start of class, including reading the standard.

This AS9110 Internal Auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own copy of the AS9110 RevC standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9110 internal auditor training - Internal airplane nose

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Quality Control and Quality Assurance Personnel
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Those who perform Supplier Audits
  • Operational Auditors

 

AS9110 Internal Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion
  2. Fully understand and interpret the AS9110:2016 Rev C requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews
  7. Conduct audits that result in real improvements to the quality system
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 


Related Courses 

AS9110 Lead Auditor Training AS9100 Rev D Lead Auditor Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training AS9145 APQP & PPAP Training

 

AS9110C and ISO 9001:2015

Probitas Certified Lead Auditor In-Person Training Course

Days: 5 • CEU Hours: 4.75

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
Days 1-4: 7:30 AM – 6:30 PM Local Time
Day 5: 7:30 AM – 11:00 AM Local Time
This course is certified by Probitas Authentication.  Successful completion of this course satisfies the AS9110 Lead Auditor training requirement for Aerospace Auditor authentication.

Even though AS9110 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

In addition to this course, aerospace auditors must also complete the IAQG sanctioned Aerospace Auditor Transition Training course to fulfill the training requirements for aerospace auditor authentication and recognition in OASIS.

 

Overview

In the aerospace maintenance, repair, and overhaul (MRO) industry, compliance with AS9110C and ISO 9001:2015 is critical to ensuring quality, safety, and customer satisfaction. Auditors must be well-prepared to assess both general and MRO-specific requirements with precision and confidence.

This in-person AS9110C Lead Auditor Training delivers a rich, immersive learning experience that goes beyond the screen. Certified by Probitas, this five-day course fulfills the formal training requirement for AS9110 Lead Auditors and equips you with the practical skills needed to conduct, manage, and lead internal, supplier, and regulatory audits.

Held in a traditional classroom setting, this training allows for deeper engagement, real-time feedback, and dynamic peer interaction. You’ll benefit from direct access to instructors, group exercises, and collaborative discussions that mirror the challenges auditors face in the field.

In this class, you will explore every phase of the audit process, including:

  • Understanding ISO 9001 and AS9110 requirements
  • Planning, scheduling, and preparing for audits
  • Conducting effective opening and closing meetings
  • Interviewing auditees using proven questioning techniques
  • Reviewing documents, processes, and records for compliance
  • Identifying nonconformities and writing audit findings
  • Following up with corrective actions and verifying effectiveness

This course is highly interactive, using case studies, role-playing scenarios, and real-time coaching to build your competence and confidence. The in-person format enhances retention, fosters professional connections, and provides a hands-on environment ideal for building strong audit leadership skills.

Whether you are advancing your career or supporting your organization’s certification goals, this training offers the structure, support, and in-depth instruction you need to succeed.

Pre-Requisites

Students will need to complete assignments before the start of class, including reading the standard.

This AS9110C Lead Auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own copy of the AS9110C standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9110c - underside of airplane nose

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Quality Control and Quality Assurance Personnel
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Those who perform Supplier Audits
  • Operational Auditors

 

AS9110 Lead Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the AS9110:2016 Rev C requirements.
  3. Develop the knowledge and skills required to become a Lead Auditor.
  4. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  5. Apply the proper interpretation of the standard in actual audit situations.`
  6. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  7. Follow-up and resolve audit trails that present themselves during the audit interviews.
  8. Conduct audits that result in real improvements to the quality system.
  9. Conform to the auditing practices outlined in ISO 19011, ISO 9001, AS9110, and AS9101.
  10. Fulfill the lead auditor training requirements of the IAQG Certified Lead Auditor program.

 


Related Courses 

AS9100 Rev D Lead Auditor Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

AATT AS9100 IAQG-Sanctioned Aerospace Auditor Transition Training

9100:2016 AATT Online Component & Instructor-Led, In-Person Training Session

 

Schedule:
Online: 10-15+ hours

Instructor-led: 4 days

IAQG Logo
Languages:
English (other IAQG-approved languages to be released separately)
Axeon is certified by Probitas Authentication and is an IAQG recognized Training Provider.  This course is certified by the IAQG, and successful completion of this course satisfies the Aerospace Auditor Transition Training requirement for AS9100 Aerospace Auditor authentication.

The IAQG-sanctioned 9100:2016 AATT has been mandated by the IAQG to satisfy the Foundation Course training requirement for 9100:2016 AQMS auditor authentication.  The 9100 Online Component includes the ISO 9001:2015 Pre-Assessment, Foundations: Understanding AS9100 Online Training, 9100:2016 Forms and Audit Reporting Training, and Trial Assessment Scenario 1 and 2. The four-day instructor-led portion of the AATT training focuses on applying the 9100:2016 requirements in audit situations using 9101:2022 forms and in consideration of 9101:2022 requirements. The fourth day of the instructor-led course is reserved for the final examination. Refer to the “Program Overview” section below for more information.

NOTE: This item includes the 9100 Online Component and the 9100 Instructor-Led Training. You will be contacted by an Axeon representative to finalize registration.

 

Program Overview

There are both optional and required modules and classes to complete the AATT program.

Required online modules must be completed before attending the instructor-led training. The online modules identified as optional are highly recommended, but not required. In the case of Trial Assessment Scenario 2, participants are encouraged to wait until the instructor-led training portion of the AATT (day 3) is completed before attempting this module.

AATT Prep Class (Optional)

The national pass rate for the AATT class is only about 30%. At Axeon, our pass rate is about 70%.

This one-day preparatory class is a game changer. It will prepare you for the AATT class, greatly increasing the amount you learn during the AATT and help you to pass the tests.

It is much more than simply a refresher of the AS9100 and AS9101. All students, no matter what their experience will benefit from this class and will have a much higher likelihood of passing the AATT.

ISO 9001:2015 Pre-Assessment (Required)

Evaluation to assess the trainees’ knowledge of specific changes in the ISO 9001:2015 standard. You are required to achieve an overall score of 80% to pass this assessment. This assessment is divided into two sections:
  • Knowledge Questions (50 questions)
  • Short Scenario Questions (6 scenarios, 12 questions)

Foundations: Understanding 9100 Online Training (Required)

This is a prerequisite to attend the Aerospace Auditor Transition Training (AATT) and will help you develop the following competencies:
  • Understanding the relationship of standards published under the IAQG umbrella.
  • Understanding the hierarchy of authority’s requirements and applicable advisory material, where to obtain additional information, and how to incorporate authority’s requirements into the AQMS audit activities.
  • Describing the IAQG 9104/sector scheme requirements for AQMS certification/registration programs
  • Describing the auditor approval requirements (as defined in 9104-3:2007)
  • Locating the OASIS database and describing its function
  • Explaining the intent and requirement of each clause/subclause of 9100:2016
  • Identifying the audit evidence required to demonstrate conformity to 9100:2016 requirements
  • Describing the documentation required by 9100:2016

9100 Forms and Audit Reporting Training (Required)

The purpose of this training is to address the requirements of 9100:2016, in the context of a third-party audit, considering the use of 9101:2022 forms and the conformity with 9101:2022 requirements.

Trial Assessment Scenario 1 and 2 & Review (Optional)

Each Trial Assessment scenario consists of a single 20-minute scenario with three question screens. The scenario asks you to evaluate audit evidence and make decisions based on your understanding of 9101:2022 and your ability to use the 9101:2022 forms. Once you complete the scenario, you will be taken to the Trial Assessment Scenario Review module, where the correct answers will be explained along with the rationale.

Pre-Requisites

Training and Entry Knowledge

  • Successful completion of QMS Lead Auditor training.
  • Working knowledge of 9100:2016 requirements.
  • Basic knowledge of ISO/IEC 17021-1, 9101:2022 requirements, and 9101 Forms.

Standard Documents

  • It is recommended that you purchase the official (published) version of 9100:2016, 9101:2022, and ISO/IEC 17021-1 standards from your local standards publication body.
  • Download the current version of 9101 forms – http://www.sae.org/iaqg/forms/.

Online Training (9100 Online Component)

  • Complete all required online modules prior to attending instructor-led training.
  • NOTE: This is a self-paced online program. You can complete the included training modules at your leisure. You will have access to the online training modules for 1 year from the initial purchase date and can access the training modules at any time. Timed assessment modules must be completed in a single session.
AATT - looking up at rocket with blue sky in background

Who Should Attend

  • Individuals seeking 9100 AQMS auditor authentication.
  • Individuals who want to be able to conduct audits to the requirements of 9100 utilizing 9101.

 

Requirements for Successful Completion

Successful completion of the 9100 AATT requires that you achieve a passing score on both the Knowledge and Application Examinations.

Knowledge Examination

The 9100/9101 Knowledge Examination is 1.5 hours in length and has sixty multiple-choice questions. Failure to achieve this score will require a full knowledge retake on the online platform. This retake must be completed in a proctored environment.

Failure to achieve the required score on the Knowledge Examination will require a full knowledge retake.

Application Examination

Your score for the application section is the combined result of your online application exam (2 hours), interview, and the continuous evaluation during the training class (which includes written reports and oral communication of conclusions regarding the case study material). If the auditor score is:

  • Equal or Greater than 80%: Auditor passes.
  • Between 60% and 79%: Auditor needs to apply to the 9100 Application Retake.
  • Below 60%: Auditor needs to re-attempt the full 9100 AATT. A full re-attempt requires that the auditor re-purchase and complete the 9100 Online Component and attend a new four-day 9100 AATT Instructor-Led Session offered by any approved AATT Training Provider.

The online application retake is 2 hours in length and follows the same structure of the final application examination on the 4th day of the training. This retake must be completed in a proctored environment. If the score is lower than 80%, another retake can be done, up to a maximum of two times. Two failures on the application retake will require applying to the entire four-day training again.

Certificates

Those who pass will receive a certificate of successful completion that satisfies the Foundations training course requirement for AA/AEA authentication through an approved AAB.

 

Agenda

Day 1
Part 1: Evaluation Criteria
Part 2: Bridge from eLearning
Part 3: Pre-Audit and Stage 1
Part 4: Audit Planning
 
Day 2
Part 1: Audit Planning (continued)
Part 2: Auditing Top Management
Part 3: Auditing Process Owners
Part 4: Auditing Process Trails
Part 5: Conclusions, Reporting, and Certification Recommendation
 
Day 3
Part 1: Conclusions, Reporting, and Certification Recommendation (Cont.)
Part 2: Roleplay (Forms Application Based on Case Study)
Part 3: Short Scenario Situations (9100/9101 Application)
Part 4: Surveillance, Recertification, and Special Audits
 
Day 4
Part 1: Assessments

Related Courses 

AS9100 Rev D Lead Auditor Training AS9110 Lead Auditor Training Prep Class for Aerospace Auditor Transition Training (AATT) AS9145 APQP & PPAP Training

 

The IAQG AS9100 AATT has been mandated and sanctioned by the IAQG. All AQMS auditors (AAs/AEAs/AIEAs) must successfully complete this course to meet the Foundations training requirement for AS9110. The course focuses on how to audit the requirements of AS9110 with a process-based approach utilizing AS9101 and is built on the foundation and concepts learned in the AS9100 AATT. The course consists of an online training, assessment, and a proctored final examination. Participants must select from one of the approved delivery methods in order to sit for the final examination.
Length: Online: 6-10+ hours
Final Examination: 2 hours Proctored
Prerequisites:*
  • AS9110 Knowledge Assessment (Online)
  • AS9110 Application Assessment (Online)
  • Foundations:  Understanding AS9110 eLearning
*Participants must successfully complete the AS9100 AATT prior to obtaining a certificate for the AS9110 AATT.
Axeon handles all the registration communication with Plexus.  You complete the prerequisite online course information and then schedule with Axeon to take the examination.  It is permissible to take the AS9110 final examination the same day as the AATT 9100 final examination.  Please contact Axeon.

Note:

  • Knowledge and Application Examination: Must achieve a minimum combined (average) score of 80%.
  • All participants are required to bring a laptop for the online final examination.

The IAQG AS9100 AATT has been mandated and sanctioned by the IAQG. All AQMS auditors (AAs/AEAs/AIEAs) must successfully complete this course to meet the Foundations training requirement for AS9120. The course focuses on how to audit the requirements of AS9120 with a process-based approach utilizing AS9101 and is built on the foundation and concepts learned in the AS9100 AATT. The course consists of an online training, assessment, and a proctored final examination. Participants must select from one of the approved delivery methods in order to sit for the final examination.
Length: Online: 6-10+ hours
Final Examination:2 hours Proctored
Prerequisites:*
  • AS9120 Knowledge Assessment (Online)
  • AS9120 Application Assessment (Online)
  • Foundations:  Understanding AS9120 eLearning
*Participants must successfully complete the AS9100 AATT prior to obtaining a certificate for the AS9120 AATT.
Axeon handles all the registration communication with Plexus.  You complete the prerequisite online course information and then schedule with Axeon to take the examination.  It is permissible to take the AS9120 final examination the same day as the AATT 9100 final examination.  Please contact us for more information.
  • Knowledge and Application Examination: Must achieve a minimum combined (average) score of 80%.
Note: All participants are required to bring a laptop for the online final examination.

Prep Class for Aerospace Auditor Transition Training (AATT)

Days: 1 • CEU Hours: 0.8

 7:30 AM – 4:30 PM MST

 

Overview

If you want to become a third-party aerospace auditor for AS9100, AS9110, or AS9120, you’ll need to complete the Aerospace Auditor Transition Training (AATT). This course is required by Probitas Authentication and recognized by the International Aerospace Quality Group (IAQG). It’s a key step toward certification but also one of the most difficult.

Many students take the AATT to advance their careers and meet personal goals. But the course is challenging, and the national pass rate is only about 30%. That’s why this one-day prep class is such a valuable investment. It lays the foundation you need to succeed in the AATT and helps you get more out of the training.

This isn’t just a refresher on AS9100 and AS9101. Whether you’re new to aerospace auditing or already have experience, this class sharpens your understanding of the standards, clarifies what to expect in the AATT, and gives you practical strategies to pass the exams. And it works. Students who take Axeon’s prep class have a much higher than average pass rate.

With Axeon’s proven approach, you’ll go into the AATT more confident, more prepared, and with a much greater chance of success.

Prerequisites

This class is scheduled a week before the AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training in order to help students prepare for the class and, ultimately, the exam.

In order to attend this class, you must have completed the prerequisites for the AATT course. So you must have passed either the AS9100 or AS9110 Lead Auditor Training.

Aerospace Auditor Transition Training - Picture of Plane ready for boarding

Who Should Attend

  • Anyone registered to take the AATT
  • Lead Auditors
  • Quality Consultants
  • Internal auditor
  • 3rd Party Auditors
  • Quality Engineers
  • Quality Managers
  • Management Representatives

 

Training Objectives 

  1. Prepare for the Aerospace Auditor Transition Training and exams.
  2. Understand how to learn more during the Aerospace Auditor Transition Training.
  3. Reflect on your knowledge of the AS9100 and AS9101.
  4. Improve the scores of the students on the Aerospace Auditor Transition Training exams.

 

Agenda

Part 1: AATT Class Overview
Part 2: In-Depth Review of AS9100 Standard

Aerospace Auditing Case Studies

Part 3: Review of AS9101 Standard

Aerospace Audit Reports

Part 4: What to expect in the AATT class

What to study
Tips to pass the exams
Common pitfalls


Related Courses 

AS9100 Rev D Lead Auditor Training AS9110 Lead Auditor Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training AS9145 APQP & PPAP Training

 

AS9100 Rev D & ISO 9001:2015

Probitas Certified Lead Auditor Training Course

Days: 5 • CEU Hours: 4.75

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
Days 1-4: 7:30 AM – 6:30 PM MST
Day 5: 7:30 AM – 11:00 AM MST
This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication.

 

Overview

In today’s competitive aerospace industry, ensuring compliance with AS9100 standards is critical for maintaining quality, meeting customer expectations, and securing contracts. Effective auditing is the foundation of a robust Quality Management System (QMS), and skilled auditors are in high demand to help organizations achieve and sustain excellence.

This interactive, live-online AS9100 lead auditor training course equips you with the knowledge and skills to conduct effective QMS audits in line with AS9100 Rev D and ISO 9001:2015 standards. You’ll learn how to interpret the verbiage of the standards and apply them to your own organization.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing techniques for auditees
  • Closing meetings and reporting

Our training includes easy-to-use tools to streamline the auditing process, ensuring you succeed regardless of your experience level or career stage.

This practical AS9100 lead auditor training course is designed to engage and empower participants. Through interactive case studies, role-playing scenarios, and other real-world exercises, you’ll not only deepen your understanding of auditing principles but also build confidence to apply them effectively in any setting.

Pre-Requisites

There are no required prerequisites for this training.

This AS9100 Lead Auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the AS9100 RevD standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9100 - Man inspecting jet engine

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Those who perform supplier audits

 

AS9100 Rev D & ISO 9001:2015 Training Objectives

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Learn how to perform high-quality audits with confidence.
  3. Improve your understanding of the Aerospace Quality Standard.
  4. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  5. Conform to the auditing practices outlined in ISO 19011, ISO 9001 and AS9101.
  6. Fulfill the lead auditor training requirements of the IAQG Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: AQMS Objectives Quiz
Part 4: In-depth Review of Standard
Lunch
Part 5: Review of Standard (cont’d)
Part 6: Exercise: Audit Case Studies (Part 1)
 
Day 2
Part 1: Exercise: Audit Case Studies (Part 2)
Part 2: Learning Game on Pre-assignment
Part 3: Test on Standard/Review & Retake
Part 4: AU Module – Part 1. Intro to Auditing
Lunch
Part 5: Test on Part 1/Review & Retake
Part 6: Part 2. Preparing for an Audit
Part 7: Test on Part 2/Review & Retake
Part 8: Part 3. Conducting the Audit
Part 9: Test on Part 3/Review & Retake
 
Day 3
Part 1: Audit Role Play Exercise 1
Part 2: Part 4. Completing the Audit
Part 3: Test on Part 4/Review & Retake
Part 4: Exercise: Writing Audit Findings
Lunch
Part 5: Audit Role Play Exercise 2
Part 6: TL Unit: Leading an Audit Team
 
Day 4
Part 1: Test on TL Unit/Review & Retake
Part 2: Aerospace Industry Unit
Part 3: Test on AS Unit/Review & Retake
Part 4: AS9101 Unit
Part 5: Process-Based Auditing
Lunch
Part 6: Audit Role Play Exercise 4
Part 7: AS9101 Quiz/Review & Retake
Part 8: Exercise 3: Closing Meeting
Part 9: Class Wrap-Up
Part 10: Test Prep
 
Day 5
Part 1: Test Preparation
Part 2: Final Examination

 


Related Courses 

AS9100 Rev D Internal Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

AS9100D & ISO 9001:2015

Probitas Certified Lead Auditor In-Person Training Course

Days: 5 • CEU Hours: 4.75

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
Days 1-4: 7:30 AM – 6:30 PM Local Time
Day 5: 7:30 AM – 11:00 AM Local Time
This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication.

 

Overview

In today’s competitive aerospace industry, ensuring compliance with AS9100 standards is critical for maintaining quality, meeting customer expectations, and securing contracts. Effective auditing is the foundation of a robust Quality Management System (QMS), and skilled auditors are in high demand to help organizations achieve and sustain excellence.

This interactive, in-person AS9100D lead auditor training course equips you with the knowledge and skills to conduct effective QMS audits in line with AS9100D and ISO 9001:2015 standards. You’ll learn how to interpret the verbiage of the standards and apply them to your own organization.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing techniques for auditees
  • Closing meetings and reporting

Our training includes easy-to-use tools to streamline the auditing process, ensuring you succeed regardless of your experience level or career stage.

This practical AS9100 lead auditor training course is designed to engage and empower participants. Through interactive case studies, role-playing scenarios, and other real-world exercises, you’ll not only deepen your understanding of auditing principles but also build confidence to apply them effectively in any setting.

Pre-Requisites

There are no required prerequisites for this training.

This AS9100 Lead Auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the AS9100D standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9100D - Man inspecting jet engine

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Those who perform supplier audits

 

AS9100D & ISO 9001:2015 Training Objectives

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Learn you to perform high-quality audits with confidence.
  3. Improve your understanding of the Aerospace Quality Standard.
  4. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  5. Conform to the auditing practices outlined in ISO 19011, ISO 9001 and AS9101.
  6. Fulfill the lead auditor training requirements of the IAQG Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: AQMS Objectives Quiz
Part 4: In-depth Review of Standard
Lunch
Part 5: Review of Standard (cont’d)
Part 6: Exercise: Audit Case Studies (Part 1)
 
Day 2
Part 1: Exercise: Audit Case Studies (Part 2)
Part 2: Learning Game on Pre-assignment
Part 3: Test on Standard/Review & Retake
Part 4: AU Module – Part 1. Intro to Auditing
Lunch
Part 5: Test on Part 1/Review & Retake
Part 6: Part 2. Preparing for an Audit
Part 7: Test on Part 2/Review & Retake
Part 8: Part 3. Conducting the Audit
Part 9: Test on Part 3/Review & Retake
 
Day 3
Part 1: Audit Role Play Exercise 1
Part 2: Part 4. Completing the Audit
Part 3: Test on Part 4/Review & Retake
Part 4: Exercise: Writing Audit Findings
Lunch
Part 5: Audit Role Play Exercise 2
Part 6: TL Unit: Leading an Audit Team
 
Day 4
Part 1: Test on TL Unit/Review & Retake
Part 2: Aerospace Industry Unit
Part 3: Test on AS Unit/Review & Retake
Part 4: AS9101 Unit
Part 5: Process-Based Auditing
Lunch
Part 6: Audit Role Play Exercise 4
Part 7: AS9101 Quiz/Review & Retake
Part 8: Exercise 3: Closing Meeting
Part 9: Class Wrap-Up
Part 10: Test Prep
 
Day 5
Part 1: Test Preparation
Part 2: Final Examination

 


Related Courses 

AS9100D Internal Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

AS9100 ISO 9001 Internal Auditor Training

Probitas Certified Live Online Course

Days: 3 • CEU Hours: 2.4

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
7:30 AM – 6:30 PM MST
This course is certified by Probitas Authentication. 

Overview

In today’s fast-paced aerospace industry, maintaining AS9100 compliance is crucial for ensuring quality, meeting customer expectations, and remaining competitive. A well-executed internal audit strengthens an organization’s Quality Management System (QMS), making trained internal auditors an invaluable resource.

This interactive, live-online AS9100 ISO 9001 internal auditor training equips you with the essential skills and knowledge to conduct effective audits in line with AS9100 and ISO 9001:2015 requirements. You’ll learn how to interpret key standards and apply them within your organization to drive continuous improvement.

Taught by expert instructors in a dynamic virtual classroom, this course covers every phase of the internal audit process, including:

  • Preparing and planning an audit
  • Conducting opening meetings and interviews
  • Evaluating processes and reviewing records
  • Identifying and reporting nonconformities
  • Leading closing meetings and ensuring follow-up actions

Through engaging discussions, virtual role-playing scenarios, and real-world case studies, you’ll gain practical experience and confidence in auditing techniques—no matter your experience level or industry background.

By the end of this course, you’ll have the tools and expertise to perform internal audits that enhance compliance, improve processes, and contribute to organizational success—all from the convenience of your home or office.

Prerequisites

There are no required prerequisites for this training.

This AS9100 internal auditor training course is beneficial for both quality novices and lifetime professionals.

All attendees are required to bring their own copy of the ISO 9001:2015 or AS9100:2016 Rev D Quality Management Standard Requirements for this training course.

These will not be provided for you.

We strongly advise you bring a paper copy or an electronic copy that allows you to take notes for your AS9100 ISO 9001 auditor training.

AS9100 ISO 9001 internal auditor training - Man inspecting jet engine

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • AS9100 ISO 9001 Internal Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits or quality assurance

 

AS9100 ISO 9001 Internal Auditor Training Objectives

  1. Prepare to conduct a solo AS9100 internal audit at successful course completion.
  2. Fully understand and interpret the AS9100:2016 Rev D and ISO 9001:2015 requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews
  7. Conduct audits that result in real improvements to the quality system
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Day 1
Part 1: Introductions and Self-Assessment

  1. Course requirements
  2. How to get the most from this experience
  3. Networking with classmates (industry professionals)
  4. Self-assessment of audit skills and internal audit programs Exercise #1
Part 2: Quality Terminology & Definitions

  1. Quality industry vernacular from AS9100 and ISO 19011
  2. Differentiating between Verification and Validation
  3. Understanding Corrective Actions and Risk Management
  4. How to converse with external auditors
  5. Terminology Exercise #2
Part 3: Requirements of AS9100

  1. Demystifying the AS9100 standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100 to quality events
  5. Audit Case Studies
Part 4: The Audit Process: Roles and Duties

  1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  2. Qualifying Auditors
  3. Duties of the IA staff
  4. Exercise #8: Preparing to be audited
 
Day 2
Part 5: The Audit Process: Performing the Audit Process

  1. Audit Tools – checklists, process maps, findings, reports
  2. Conducting Audit Interviews Exercise #9
  3. Exercise #10 with Morgan Case Studies
Part 6: The Audit Process: Audit Skills and Techniques

  1. Audit Interviewing techniques
  2. Continual improvement techniques
  3. Process Auditing methods
  4. Developing a continual improvement attitude in the organization
  5. Exercise #11 Writing Audit Findings
  6. Exercise #12 Evaluating the effectiveness of Audits
  7. Exercise #13 Application of Process Auditing techniques
  8. Review written NCRs and OFIs
 
Day 3
Part 7: The Audit Process: Finalizing the Audit

  1. Developing an Audit Schedule
  2. Conducting Audits – Live Audit
  3. Writing Non-Conformities
  4. Prepare a PEAR form
  5. Writing the audit report
  6. Exercise #14 Writing and audit report
  7. Exercise #15 Writing Non-Conforming Reports
  8. Exercise #16 Conducting a Closing Meeting
Review and Examination of Certificate

 


Related Courses 

AS9100D Lead Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

AS9100 Auditor Training with ISO 9001

Probitas Certified Internal Auditor In-Person Training Course

Days: 3 • CEU Hours: 2.4

 

Audience:
Beginner to Advanced
Probitas Authentication
Schedule:
7:30 AM – 6:30 PM Local Time
This course is certified by Probitas Authentication. 

Overview

In today’s highly competitive aerospace industry, ensuring compliance with AS9100 standards is essential for maintaining quality, meeting customer requirements, and staying ahead of the competition. A strong Quality Management System (QMS) relies on effective internal audits, making skilled internal auditors a valuable asset to any organization.

This hands-on, in-person AS9100D auditor training course is designed to provide you with the knowledge and tools needed to perform and participate in effective audits in accordance with AS9100D and ISO 9001:2015 standards. You’ll gain a clear understanding of how to interpret the requirements and apply them within your organization.

Led by experienced instructors, this course guides you through all stages of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Interviewing techniques
  • Holding closing meetings
  • Reporting and follow-up actions

You’ll also receive practical tools to simplify the auditing process, ensuring success no matter your experience level or career stage.

This engaging AS9100 auditor training course combines real-world exercises, role-playing scenarios, and interactive discussions to reinforce your understanding of audit principles. By the end of the course, you’ll be equipped with the confidence and skills to conduct internal audits that support continuous improvement and organizational success.

Prerequisites

There are no required prerequisites for this training.

This AS9100 auditor training course is beneficial for both quality novices and lifetime professionals.

All attendees are required to bring their own copy of the ISO 9001:2015 or AS9100:2016 Rev D Quality Management Standard Requirements for this training course.

These will not be provided for you.

We strongly advise you bring a paper copy or an electronic copy that allows you to take notes for your ISO 9001 and AS9100 auditor training.

AS9100 auditor training - Man inspecting jet engine

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits or quality assurance

 

ISO 9001 & AS9100 Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the AS9100:2016 Rev D and ISO 9001:2015 requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews
  7. Conduct audits that result in real improvements to the quality system
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Day 1
Part 1: Introductions and Self-Assessment

  1. Course requirements
  2. How to get the most from this experience
  3. Networking with classmates (industry professionals)
  4. Self-assessment of audit skills and internal audit programs Exercise #1
Part 2: Quality Terminology & Definitions

  1. Quality industry vernacular from AS9100 and ISO 19011
  2. Differentiating between Verification and Validation
  3. Understanding Corrective Actions and Risk Management
  4. How to converse with external auditors
  5. Terminology Exercise #2
Part 3: Requirements of AS9100

  1. Demystifying the AS9100 standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100 to quality events
  5. Audit Case Studies
Part 4: The Audit Process: Roles and Duties

  1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  2. Qualifying Auditors
  3. Duties of the IA staff
  4. Exercise #8: Preparing to be audited
 
Day 2
Part 5: The Audit Process: Performing the Audit Process

  1. Audit Tools – checklists, process maps, findings, reports
  2. Conducting Audit Interviews Exercise #9
  3. Exercise #10 with Morgan Case Studies
Part 6: The Audit Process: Audit Skills and Techniques

  1. Audit Interviewing techniques
  2. Continual improvement techniques
  3. Process Auditing methods
  4. Developing a continual improvement attitude in the organization
  5. Exercise #11 Writing Audit Findings
  6. Exercise #12 Evaluating the effectiveness of Audits
  7. Exercise #13 Application of Process Auditing techniques
  8. Review written NCRs and OFIs
 
Day 3
Part 7: The Audit Process: Finalizing the Audit

  1. Developing an Audit Schedule
  2. Conducting Audits – Live Audit
  3. Writing Non-Conformities
  4. Prepare a PEAR form
  5. Writing the audit report
  6. Exercise #14 Writing and audit report
  7. Exercise #15 Writing Non-Conforming Reports
  8. Exercise #16 Conducting a Closing Meeting
Review and Examination of Certificate

 


Related Courses 

AS9100D Lead Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

AS9100 Internal Auditor Training with ISO 9001

Days: 2 • CEU Hours: 1.9

7:30 AM – 4:30 PM

 

Overview

In the aerospace and defense industry, internal audits are more than just a compliance requirement. They are a strategic tool for improving processes, ensuring product quality, and meeting the demanding expectations of customers and regulators. AS9100 internal auditors play a key role in helping organizations maintain certification and stay competitive in a highly regulated market.

This two-day, live-online AS9100 Internal Auditor training course—integrated with ISO 9001:2015—gives you the skills and knowledge to perform internal audits with confidence. Whether you are new to auditing or need a structured refresher, this course will help you interpret the requirements of AS9100 Rev D and ISO 9001:2015 and apply them in real-world audit scenarios.

Guided by experienced instructors, you’ll cover each stage of the internal audit process:

  • Audit planning and preparation
  • Conducting opening meetings
  • Interviewing auditees and collecting objective evidence
  • Evaluating conformance to AS9100 and ISO 9001
  • Reporting results and closing the audit

This AS9100 Internal Auditor training course emphasizes practical learning. Through hands-on exercises, case studies, and realistic audit simulations, you will build the skills needed to conduct effective, value-added audits. The training avoids unnecessary theory and focuses instead on what internal auditors truly need to know and do on the job.

Delivered entirely online in a live, instructor-led format, this course offers a flexible and engaging way to strengthen your internal audit capabilities without stepping away from your day-to-day responsibilities.

Pre-Requisites

There are no required prerequisites for this training.

This AS9100 Internal Auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed or virtual copy of the AS9100 Rev D standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9100 internal auditor training - front of an airplane

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Individuals assisting their organizations toward AS9100:2016 registration
  • Individuals who are frequently audited
  • Anyone engaged in quality audits

 

ISO 9001 & AS9100 Internal Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the AS9100:2016 requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements.
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews.
  7. Conduct audits that result in real improvements to the quality system.
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Part 1: Introductions and Self-Assessment
As9100 internal auditor training course requirements
How to get the most from this experience
Networking with industry professionals classmates
Exercise #1: Self-assessment of audit skills and internal audit programs 
 
Part 2: Quality Terminology & Definitions
Quality industry vernacular from ISO 9000, ISO 19011
Differentiating between Verification and Validation
Understanding Corrective and Preventive Actions
How to converse with external auditors
Exercise #2: Terminology
 
Part 3: Requirements of ISO 9001:2015
Demystifying the ISO 9001:2015 standard
Interpreting and cross-referencing the quality standard
Analyzing audit findings
Exercise #3-#7: Short case studies in quality events
 
Part 4: The Audit Process: Roles and Duties
Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
Qualifying Auditors
Duties of the IA staff
Exercise #8: Preparing to be Audited
 
Part 5: The Audit Process: Performing the Audit Process
Audit Tools – checklists, process maps, findings, reports
Exercise #9: Conducting Audit Interviews
Exercise #10: Quality Event Case Studies
 
Part 6: The Audit Process: Audit Skills & Techniques
Audit Interviewing techniques
Continual improvement techniques
Process Auditing methods
Developing a continual improvement attitude in the organization
Exercise #11: Writing Audit Findings
Exercise #12: Evaluating the Effectiveness of Audits
Exercise #13: Application of Process Auditing Techniques
 
Part 7: The Audit Process: Finalizing the Audit
Writing the audit report
Opening and Closing Meetings
Exercise #14: Writing an Audit Report
Exercise #15: Writing Non-Conforming Reports
Exercise #16: Conducting a Closing Meeting
 
Review & Examination for Certificate

 


Related Courses 

ISO 9001 Lead Auditor Training AS9100 Lead Auditor Training Root Cause Analysis & CAPA Training AS9102 First Article Inspection Training

 

Design Control Training

For Design & Development Requirements

Days: 2 • CEU Hours: 1.9

7:30 AM – 4:30 PM

 

Overview

In medical device and manufacturing industries, design controls are more than just a regulatory requirement. They form the foundation for developing safe, effective, and reliable products that meet customer needs while complying with global standards. Organizations that manage design controls effectively not only maintain compliance but also reduce risks, avoid costly redesigns, and ensure smooth product launches.

This two-day Design Control Training course, aligned with ISO 9001:2015, ISO 13485:2016, FDA 21 CFR 820 (QMSR), and EU MDR 2017/745, gives you the skills and knowledge to implement, manage, and audit design and development activities with confidence. Whether you are new to design controls or seeking a structured refresher, this course will help you interpret the requirements and apply them in real-world scenarios.

Guided by experienced instructors, you will cover each stage of the design and development process:

  • Developing design plans and choosing methodologies
  • Defining and managing design inputs and outputs
  • Conducting effective design reviews
  • Performing verification and validation activities
  • Managing design transfer, changes, and technical documentation
  • Applying risk management and usability principles throughout the lifecycle

This training emphasizes practical application over theory. Through hands-on activities, case studies, and interactive discussions, you will build the skills needed to integrate design controls into your Quality Management System and prepare for audits and regulatory inspections.

Delivered in a live, instructor-led format, this course offers an engaging and flexible way to strengthen your design and development expertise without stepping away from your day-to-day responsibilities.

Pre-Requisites

Our goal is to meet everyone at their current level and increase it.

Medical Device students should review the ISO 13485:2016 Standard Clause 7.3 and 21 CFR 820.30 to prepare for class.

General Manufacturing students should review ISO 9001:2015 Clause 8.3 to prepare for class.

By reviewing these materials before class, you will come in aware of the content of the standards and be ready to learn how to apply them.

Design Control - Two people looking at a piece of paper with designs and making notes

Who Should Attend

  • Quality Managers/Engineers
  • Person Responsible for Regulatory Compliance (PRRC)
  • Regulatory Affairs Managers
  • Procurement Managers
  • Design Engineers
  • Process Engineers

 

Design Control Training Objectives

  1. Understand the regulatory basis of Design & Development (ISO 9001, ISO 13485, FDA QMSR, EU MDR).
  2. Learn the key elements of Design & Development: planning, inputs, outputs, reviews, verification, validation, transfer, and changes.
  3. Practice applying risk management (ISO 14971, ISO 31000) and GSPR (EU MDR Annex I) requirements to design activities.
  4. Gain tools for preparing compliant Medical Device File (MDF) and Technical Documentation.
  5. Develop strategies to integrate Design & Development within the Quality Management System.

 

Agenda

Part 1: Introduction & Course Overview
Welcome, expectations, introductions
Why Design & Development are critical (case examples)
 
Part 2: Medical Device Lifecycle & Regulatory Context
Device lifecycle under ISO 13485, FDA, EU MDR
Where Design & Development fit within R&D and product realization
 
Part 3: Design Planning & Methodology
Design planning requirements (ISO 9001 Clause 8.3 & ISO 13485 §7.3.2, 21 CFR 820.30(b))
Choosing a methodology: Waterfall, Agile, Lean, Concurrent Engineering
Activity: Drafting a Design & Development Plan
 
Part 4: Design Inputs & Outputs
Sources of input: User needs, regulatory, risk, usability
Outputs: Specifications, acceptance criteria, BOMs, Device Master Records/Medical Device
Activity: Review of design input/output checklists
 
Part 5: Design Reviews
Formal review requirements and documentation
Cross-functional participation and recordkeeping
 
Part 6: Design Verification & Validation
Verification vs Validation: Key differences and methods
Case studies and practical examples
Activity: Review and critique a verification/validation example
 
Part 7: Design Transfer & Change Control
Requirements for DHF, Technical Documentation, Device Master Record
Handling design transfer and post-market changes
GSPR Annex I checklist integration
 
Part 8: Risk Management, Usability & Human Factors
ISO 14971: Risk management throughout lifecycle
Integrating usability (IEC 62366) and human factors into design
Activity: Apply risk controls to design case study
 
Part 9: Wrap-Up & Next Steps
Review of learning objectives
Q&A session
Preparing your organization for audits and inspections

 


Related Courses 

ISO 13485 Lead Auditor Training ISO 9001 Lead Auditor Training Root Cause Analysis & CAPA Training EU Medical Device Regulation (EU MDR) Training

 

ISO 9001 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.6

 7:30 AM – 5:30 PM MST

 

Overview

In today’s fast-paced business environment, organizations must ensure compliance with ISO 9001:2015 to maintain quality, enhance efficiency, and stay competitive. Effective auditing is the backbone of a strong Quality Management System (QMS), and skilled lead auditors play a critical role in driving continuous improvement.

This interactive, live-online ISO 9001 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits with confidence. Recognized by Exemplar Global, this course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

  • Understanding ISO 9001:2015 requirements and quality management principles
  • Audit planning, scheduling, and preparation
  • Conducting opening and closing meetings
  • Reviewing documentation, records, and processes
  • Interviewing auditees and gathering objective evidence
  • Identifying and reporting nonconformities
  • Implementing corrective actions and follow-up procedures

This hands-on ISO 9001 lead auditor training program is designed to actively involve and equip participants with essential auditing skills. By engaging in real-world exercises, role-playing activities, and in-depth case studies, you will enhance your grasp of auditing concepts while gaining the confidence to implement them successfully in any environment.

Prerequisites

There are no required prerequisites for this training.

This ISO 9001 lead auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the ISO 9001:2015 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 9001 Lead Auditor Training - People talking at table

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 

ISO 9001 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Conform to the auditing practices outlined in ISO 19011.
  5. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: AQMS Objectives Quiz
Part 4: In-depth Review of Standard
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Review Test
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Exercise: Conducting a Closing Meeting
Part 4: Writing the Audit Report
Part 5: Test on TL Unit / Review Test
Part 6: Conclusion & Evaluations

 


Related Courses 

In-Person ISO 9001 Lead Auditor Training AS9100D Lead Auditor Training ISO 13485 Lead Auditor Training Root Cause Analysis & Corrective Action Training

 

ISO 9001:2015 Quality Management Systems

 In-Person Lead Auditor Training Course Recognized by Exemplar Global

Days: 4 • CTU Hours: 3.6

 7:30 AM – 5:30 PM Local Time

 

Overview

In today’s fast-paced business environment, organizations must ensure compliance with ISO 9001:2015 to maintain quality, enhance efficiency, and stay competitive. Effective auditing is the backbone of a strong Quality Management System (QMS), and skilled lead auditors play a critical role in driving continuous improvement.

This interactive, in-person ISO 9001:2015 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits with confidence. Recognized by Exemplar Global, this course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

  • Understanding ISO 9001:2015 requirements and quality management principles
  • Audit planning, scheduling, and preparation
  • Conducting opening and closing meetings
  • Reviewing documentation, records, and processes
  • Interviewing auditees and gathering objective evidence
  • Identifying and reporting nonconformities
  • Implementing corrective actions and follow-up procedures

Through hands-on workshops, case studies, and real-world scenarios, you’ll develop the confidence to lead audits effectively, regardless of your industry or experience level.

Topics Covered

  • Analyzing Processes to Identify Resources and
  • Critical Controls
  • Analyzing Operational Risk
  • Reviewing System Documentation and Preparing an Audit Plan
  • Reviewing Processes and Preparing Checklists
  • Verifying Facts
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action
ISO 9001 - People talking at table

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Internal Auditors
  • Quality Consultants
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 


Related Courses 

ISO 9001:2015 Internal Auditor Training AS9100D Lead Auditor Training ISO 13485 Lead Auditor Training Root Cause Analysis & Corrective Action Training

 

ISO 9001 Internal Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

 

ISO 9001 Internal Auditor Overview

In today’s competitive manufacturing industry, maintaining compliance with ISO 9001 is essential for ensuring product quality, meeting customer expectations, and driving continuous improvement. A strong Quality Management System (QMS) depends on effective internal audits, making skilled internal auditors a valuable asset to any organization.

This interactive, live-online ISO 9001 auditor training provides you with the knowledge and tools needed to perform and participate in effective audits in accordance with ISO 9001:2015. Recognized by Exemplar Global, this ISO 9001 Internal auditor course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization, all from the convenience of your home or office.

Taught by experienced instructors in a dynamic virtual classroom, this course covers all key stages of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Interviewing techniques for gathering evidence
  • Holding closing meetings and reporting findings
  • Implementing corrective actions and follow-up

You’ll also receive practical tools to simplify the auditing process, ensuring success regardless of your experience level or career stage.

This engaging ISO 9001 internal auditor training combines real-world exercises, virtual role-playing scenarios, and interactive discussions to reinforce your understanding of audit principles. By the end of the course, you’ll have the confidence and skills to conduct internal audits that strengthen your QMS and contribute to organizational success.

Topics Covered

  • Quality Management Principles
  • Standards and Guidelines (Including History of Standards)
  • Interpretation of ISO 9001
  • Documentation and Records
  • Introduction to Quality Audit
  • Audit Scheduling and Preparation
  • Performing the Audit
  • Reporting the Audit
  • Corrective Action and Follow-Up
ISO 9001 Internal Auditor Training - People talking at table

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits or quality assurance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Quality Management Systems Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

 

 


Related Courses 

ISO 9001 Lead Auditor Training AS9100D Lead Auditor Training ISO 13485 Lead Auditor Training Root Cause Analysis & Corrective Action Training

ISO 9001 Internal Auditor In-Person Training

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM Local Time

 

ISO 9001 Internal Auditor Overview

Achieving and maintaining ISO 9001 certification isn’t just about compliance—it’s about building a culture of quality, improving efficiency, and staying competitive in today’s manufacturing landscape. ISO 9001 Internal auditors play a crucial role in identifying risks, uncovering opportunities for improvement, and ensuring that processes align with both customer expectations and industry standards. To conduct these audits effectively, organizations need well-trained internal auditors who understand how to assess compliance and drive meaningful change.

This in-person ISO 9001 Internal Auditor Training provides a hands-on, interactive learning experience designed to equip you with the skills and confidence to conduct thorough audits. Recognized by Exemplar Global, this course teaches you how to interpret ISO 9001:2015 requirements, assess compliance, and drive meaningful improvements within your organization.

Guided by expert instructors in a collaborative classroom environment, you’ll gain practical experience with every stage of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Interviewing techniques for gathering evidence
  • Holding closing meetings and reporting findings
  • Implementing corrective actions and follow-up strategies

The benefits of in-person ISO 9001 Internal Auditor training go beyond just learning the material. This format allows for direct engagement with instructors, real-time feedback, and valuable discussions with peers. Through group exercises, role-playing scenarios, and hands-on practice, you’ll refine your auditing skills in a way that online courses simply can’t match.

By the end of this training, you’ll be well-prepared to conduct internal audits that strengthen your QMS, enhance compliance, and contribute to your organization’s overall success. Whether you’re new to auditing or looking to sharpen your skills, this immersive course ensures you leave with practical knowledge and the confidence to apply it immediately.

Topics Covered

  • Quality Management Principles
  • Standards and Guidelines (Including History of Standards)
  • Interpretation of ISO 9001
  • Documentation and Records
  • Introduction to Quality Audit
  • Audit Scheduling and Preparation
  • Performing the Audit
  • Reporting the Audit
  • Corrective Action and Follow-Up
ISO 9001 Internal Auditor Training - People talking in a warehouse

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits or quality assurance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Quality Management Systems Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

 

 


Related Courses 

ISO 9001 Lead Auditor Training AS9100D Lead Auditor Training ISO 13485 Lead Auditor Training Root Cause Analysis & Corrective Action Training

 

ISO 9001:2015 & IATF 16949:2016 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 5 • CEU Hours: 4.4

 7:30 AM – 5:30 PM MST

 

Overview

The automotive industry demands rigorous quality standards, and organizations certified to IATF 16949:2016 must ensure their auditors are prepared to meet those expectations. Effective auditing is essential for maintaining compliance, managing risk, and driving performance across the supply chain.

This dynamic, five-day live-online ISO 9001 & IATF 16949 Lead Auditor Training prepares you to conduct, manage, and lead audits to both standards with confidence. Recognized by Exemplar Global, the course covers key requirements of ISO 9001:2015 and IATF 16949:2016, including Core Tools and Customer-Specific Requirements, while aligning with ISO 19011 audit guidelines.

Led by experienced instructors, you’ll explore each phase of the audit process, including:

  • Interpreting ISO 9001 & IATF 16949 requirements in practical terms.
  • Planning and preparing for internal, second-party, and third-party audits.
  • Conducting effective opening and closing meetings.
  • Interviewing auditees and collecting objective evidence.
  • Identifying nonconformities and writing audit findings.
  • Leading audit teams and reporting results professionally.
  • Applying Core Tools and customer-specific expectations in audits.

Through interactive exercises, case studies, and role-playing scenarios, you’ll build the skills and confidence needed to perform high-value audits in automotive and manufacturing environments, all from the convenience of a live-online setting.

Prerequisites

There are no required prerequisites for this training.

This ISO 9001 & IATF 16949 lead auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the ISO 9001:2015 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

IATF 16949 Training - Industrial worker in safety gear walking in factory with back to camera

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Those who perform third-party (ISO/IATF) certification audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 

ISO 9001 & IATF 16949 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Conform to the auditing practices outlined in ISO 19011.
  5. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: In-depth Review of Standard
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standards
Part 4: Review Test
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Exercise: Conducting a Closing Meeting
Part 4: Writing the Audit Report
Part 5: Test on TL Unit / Review Test
Part 6: Conclusion & Evaluations
 
Day 5
Part 1: Linking Automotive Core Tools to IATF 16949
Part 2: Customer Specific Requirements
Part 3: Management Systems Auditing Exercise
Part 4: CSR/Core Tools Examination

 


Related Courses 

In-Person ISO 9001 Lead Auditor Training IATF 16949 & ISO 9001 Internal Auditor Training IATF 16949 Lead Auditor (TS 16949) Training Automotive Core Tools Training

 

ISO 9001 Internal Auditor Training

Days: 2 • CEU Hours: 1.9

7:30 AM – 4:30 PM

 

Overview

In today’s competitive business environment, a strong internal audit program is essential for maintaining ISO 9001 certification, improving operational efficiency, and driving continuous improvement. Skilled internal auditors help organizations stay compliant, identify risks, and uncover opportunities for growth.

This two-day, live-online ISO 9001 Internal Auditor training course is a great option for anyone who needs a quick, effective introduction to internal auditing or a focused refresher on the standard. Whether you’re new to ISO 9001 or looking to sharpen your skills, you’ll gain the tools and knowledge to plan, conduct, and report internal audits with confidence.

Led by experienced instructors, you’ll cover every stage of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Interviewing auditees and gathering objective evidence
  • Evaluating conformance to ISO 9001:2015
  • Closing meetings and audit reporting

The ISO 9001 internal auditor training course is delivered entirely online in a live, instructor-led format, providing flexibility and convenience without sacrificing interactivity or engagement.

The training focuses on practical application rather than academic theory. Through case studies, hands-on activities, and realistic audit scenarios, you’ll gain real-world experience that reinforces your learning and prepares you to contribute immediately to your organization’s audit program.

Pre-Requisites

There are no required prerequisites for this training.

This ISO 9001 Internal Auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed or virtual copy of the ISO 9001 standard. 

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 9001 internal auditor training - two people work on a computer

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits will benefit from this training.

 

ISO 9001 Internal Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the ISO 9001:2015 requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements.
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews.
  7. Conduct audits that result in real improvements to the quality system.
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Part 1: Introductions and Self-Assessment
Course requirements
How to get the most from this experience
Networking with industry professionals classmates
Exercise #1: Self-assessment of audit skills and internal audit programs 
 
Part 2: Quality Terminology & Definitions
Quality industry vernacular from ISO 9000, ISO 19011
Differentiating between Verification and Validation
Understanding Corrective and Preventive Actions
How to converse with external auditors
Exercise #2: Terminology
 
Part 3: Requirements of ISO 9001:2015
Demystifying the ISO 9001:2015 standard
Interpreting and cross-referencing the quality standard
Analyzing audit findings
Exercise #3-#7: Short case studies in quality events
 
Part 4: The Audit Process: Roles and Duties
Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
Qualifying Auditors
Duties of the IA staff
Exercise #8: Preparing to be Audited
 
Part 5: The Audit Process: Performing the Audit Process
Audit Tools – checklists, process maps, findings, reports
Exercise #9: Conducting Audit Interviews
Exercise #10: Quality Event Case Studies
 
Part 6: The Audit Process: Audit Skills & Techniques
Audit Interviewing techniques
Continual improvement techniques
Process Auditing methods
Developing a continual improvement attitude in the organization
Exercise #11: Writing Audit Findings
Exercise #12: Evaluating the Effectiveness of Audits
Exercise #13: Application of Process Auditing Techniques
 
Part 7: The Audit Process: Finalizing the Audit
Writing the audit report
Opening and Closing Meetings
Exercise #14: Writing an Audit Report
Exercise #15: Writing Non-Conforming Reports
Exercise #16: Conducting a Closing Meeting
 
Review & Examination for Certificate

 


Related Courses 

ISO 9001 Lead Auditor Training AS9100 Lead Auditor Training Root Cause Analysis & CAPA Training ISO 13485 Lead Auditor Training

ISO 13485 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

In the highly regulated medical device industry, ensuring compliance with ISO 13485 and FDA requirements is essential for maintaining quality, meeting customer expectations, and achieving market success. Effective auditing is a cornerstone of a strong Quality Management System (QMS), and skilled auditors are vital for helping organizations navigate complex regulatory landscapes.

This interactive, live-online ISO 13485 Lead Auditor Training course provides the knowledge and practical skills needed to conduct QMS audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this course prepares you to interpret the standard’s requirements and apply them to your own organization, ensuring compliance with both international and U.S. regulations.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing auditees
  • Closing meetings and reporting findings

This practical, hands-on ISO 13485 lead auditor training course goes beyond theory, using case studies, role-playing, and interactive exercises to build real-world auditing competence. By the end of the training, you’ll have the confidence and expertise to conduct internal, supplier, and third-party audits, helping your organization maintain compliance and drive continuous improvement.

Prerequisites

There are no required prerequisites for this training.

This ISO 13845 lead auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 13485 Lead Auditor Training - Doctor giving patient an ultrasound exam

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Those who perform supplier audits
  • Those who perform third-party (ISO certification) audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
MD – Medical Devices Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.

 

ISO 13485 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard and 21 CFR 820.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: In-depth Review of Standard
Part 4: Exercise: Audit Case Studies
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Test on Standard
Part 3: Review Test
Part 4: Review 21 CFR 820 & Exercise
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Exercise: Conducting a Closing Meeting
Part 4: Writing the Audit Report
Part 5: Test on TL Unit / Review Test
Part 6: Conclusion & Evaluations

 


Related Courses

In-Person ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training EU Medical Device Regulation (EU MDR) Training

 

ISO 9001 Revision & IA9100 Early Transition Training

 Days: 1 • CEU Hours: 0.8

 7:30 AM – 4:30 PM MST

Overview

In today’s competitive and compliance-driven manufacturing and aerospace sectors, staying ahead of standards revisions isn’t optional—it’s strategic. Major changes to ISO 9001 and AS9100 (IA9100) are coming, and organizations that wait risk falling behind, failing audits, or scrambling to retrofit their systems under pressure.

This live-online, instructor-led course gives you early access to the information and guidance you need to lead a smooth, confident transition. One of Axeon’s own consultants serves on the ISO 9001 revision committee, giving you a direct line to the changes as they unfold. You’ll get a clear understanding of what’s coming, how it impacts your QMS, and what steps you can take now to prepare, well before the final draft of ISO 9001:2026 is released.

Whether you’re preparing for recertification, leading a QMS implementation, or simply want to give your team a competitive edge, this 1-day course helps you act early, reduce risk, and plan smarter.

Prerequisites

There are no required prerequisites.

This course is designed for quality novices and life-time professionals. All quality professionals will benefit from the instructor’s expertise and the opportunity to share their own experiences.

ISO 9001 Revision & IA9001 Early Transition Training - Engineer Testing System

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditors
  • Internal Auditors
  • Quality Consultants
  • AS9100 and ISO 9001 implementation team members
  • Managers who are audited in QMS audits
  • Compliance officers and quality engineers
  • Anyone responsible for QMS planning or certification readiness

 

Training Objectives 

  1. Understand the differences between the current ISO 9001 standard and the ISO 9001 revision.
  2. Understand how these differences apply to and affect a QMS.
  3. Improve your understanding of the Manufacturing and Aerospace Quality Standards.
  4. Apply the proper interpretation of the standard to your situation.

 

Agenda

Part 1: Reasons For/Sources of Changes for ISO 9001 Revision and IA9100
Part 2: What Is Publicly Shareable So Far
Part 3: Activity #1: Terminology

Part 4: Differences Between ISO 9001: 2015 and ISO 9001: 2026

  • Notes on Manufacturing Ethics
  • ISO 10010: 2022: Guidance to Understand, Evaluate, and Improve Organizational Quality Culture
  • Activity #2: Ranking & Selecting Opportunities
Part 5: AS9100 Transition to IA9100
Part 6: Differences Between AS9100 and IA9100

Part 7: ISO 14001 Amendment

  • Implications for ISO 9001 and IA9100
Part 8: Final Questions and Wrap-Up

 

Testimonials

The trainer was very courteous and patient with the questions asked, and they were very knowledgeable with the standard changes.
Manager of Training & Personalization
ISO 9001:2015 Certified Wellness Manufacturing Company
The trainer did a great job of including everyone, and I felt good providing answers in front of others.
Operations Manager
ISO 9001:2015 Certified IC Programming Company

ISO 13485 Lead Auditor Training (In-Person)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

Compliance with ISO 13485 and FDA regulations is critical for medical device manufacturers to ensure product quality, meet customer expectations, and maintain regulatory approval. A well-executed audit program is essential for identifying risks, improving processes, and demonstrating compliance. Skilled lead auditors play a crucial role in helping organizations uphold these standards and achieve long-term success.

This in-person ISO 13485 Lead Auditor Training course provides a structured, hands-on approach to auditing Medical Device Quality Management Systems (QMS). Recognized by Exemplar Global, this program equips participants with the knowledge and practical skills to conduct audits in alignment with ISO 13485:2016 and 21 CFR 820. Through real-world applications, you’ll learn how to interpret and apply the standard’s requirements within your organization.

Led by experienced instructors, this course covers every stage of the audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing auditees
  • Closing meetings and reporting findings

This ISO 13485 Lead Auditor in-person training experience provides direct interaction with instructors and peers, fostering deeper discussions, immediate feedback, and a more immersive learning environment. Hands-on exercises, role-playing scenarios, and case studies reinforce key auditing techniques, ensuring you leave the course with practical, applicable skills.

By the end of the program, you’ll be prepared to conduct internal, supplier, and third-party audits with confidence, helping your organization maintain compliance and drive continuous improvement.

Prerequisites

There are no required prerequisites for this training.

This ISO 13845 lead auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 13485 Lead Auditor Training - Doctor looking at x-rays

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Those who perform supplier audits
  • Those who perform third-party (ISO certification) audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
MD – Medical Devices Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

This course is recognized by Exemplar Global as meeting the knowledge requirements for ISO 13485 Lead Auditor Certification in Medical Device Quality Management Systems.

 

ISO 13485 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become an ISO 13485 Lead Auditor.
  2. Improve your understanding of the international standard and 21 CFR 820.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: In-depth Review of Standard
Part 4: Exercise: Audit Case Studies
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Test on Standard
Part 3: Review Test
Part 4: Review 21 CFR 820 & Exercise
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Exercise: Conducting a Closing Meeting
Part 4: Writing the Audit Report
Part 5: Test on TL Unit / Review Test
Part 6: Conclusion & Evaluations

 


Related Courses

Live-Online ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training EU Medical Device Regulation (EU MDR) Training

 

ISO 13485 Course for Internal Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

 

Overview

In the highly regulated medical device industry, maintaining compliance with ISO 13485 and FDA requirements is essential for ensuring product quality, meeting customer expectations, and achieving regulatory approval. Internal auditing plays a critical role in sustaining an effective Quality Management System (QMS), and well-trained auditors are key to identifying risks, ensuring compliance, and driving continuous improvement.

This interactive, live-online ISO 13485 course for Internal Auditor training provides the essential knowledge and hands-on skills needed to conduct internal audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this training equips you with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can apply them effectively within your organization.

Led by expert instructors, you’ll gain insight into every stage of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing auditees
  • Closing meetings and reporting findings

This course goes beyond theory and uses real-world case studies, role-playing exercises, and interactive discussions to build confidence and competence in auditing. By the end of the training, you’ll be prepared to conduct internal and supplier audits as well as help your organization maintain compliance and improve its QMS.

Prerequisites

There are no required prerequisites for this training.

This ISO 13845 course for internal auditor training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 13485 Course - Lab organizing samples

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Those who perform supplier audits
  • Those who perform third-party (ISO certification) audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
MD – Medical Devices Management Systems
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

 

ISO 13485 Course Objectives 

  1. Develop the knowledge and skills required to become an Internal Auditor.
  2. Improve your understanding of the international standard and 21 CFR 820.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: In-depth Review of Standard
Part 4: Exercise: Audit Case Studies
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Test on Standard
Part 3: Review Test
Part 4: Review 21 CFR 820 & Exercise
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training EU Medical Device Regulation (EU MDR) Training

ISO 13485 Internal Auditor Training (In-Person)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

 

Overview

In the highly regulated medical device industry, ensuring compliance with ISO 13485 and FDA requirements is essential for maintaining quality, meeting customer expectations, and achieving market success. Internal auditing is a critical function that helps organizations identify risks and drive continuous improvement.

This in-person ISO 13485 Internal Auditor Training provides an immersive, face-to-face learning environment where you can engage directly with expert instructors and industry peers. Unlike online training, this in-person format allows for real-time feedback, hands-on exercises, and collaborative discussions, ensuring you leave with the confidence and competence to conduct internal audits effectively. Recognized by Exemplar Global, this immersive training experience ensures you leave with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can immediately apply them in your organization.

Led by expert instructors, you’ll gain insight into every stage of the internal audit process, including:

  • Audit planning and preparation
  • Conducting opening meetings
  • Document and records review
  • Interviewing auditees
  • Closing meetings and reporting findings

With case studies, group exercises, and audit role-playing, you’ll gain practical experience that you simply can’t get from a virtual classroom. The face-to-face setting fosters deeper engagement, encourages networking with other quality professionals, and ensures you receive immediate, personalized guidance tailored to your needs.

Prerequisites

There are no required prerequisites for this training.

This ISO 13845 course for internal auditor training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 13485 - Lab organizing samples

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Audit Program Managers
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Top Management
  • Managers who are audited in QMS audits
  • Those who perform supplier audits
  • Those who perform third-party (ISO certification) audits
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
MD – Medical Devices Management Systems
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

 

ISO 13485 Internal Auditor Objectives 

  1. Develop the knowledge and skills required to become an Internal Auditor.
  2. Improve your understanding of the international standard and 21 CFR 820.
  3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  4. Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History of Quality Management
Part 3: In-depth Review of Standard
Part 4: Exercise: Audit Case Studies
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Test on Standard
Part 3: Review Test
Part 4: Review 21 CFR 820 & Exercise
Part 5: AU Module – Part 1. Intro to Auditing
Part 6: Test on Part 1 / Review Test
Part 7: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Part 4. Completing the Audit
Part 6: Test on Part 4 / Review Test
Part 7: Exercise: Writing Audit Findings

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training EU Medical Device Regulation (EU MDR) Training

ISO 13485 Internal Auditor Training

Days: 2 • CEU Hours: 1.9

 Day 1: 7:30 AM – 5:30 PM MST

Day 2: 7:30 AM – 4:00 PM MST

 

Overview

ISO 13485 is the internationally recognized standard for quality management in the medical device industry. Developed by the International Organization for Standardization (ISO), this standard ensures that medical devices are safe, effective, and meet the needs of patients and end-users.

Compliance with ISO 13485 not only demonstrates your organization’s commitment to quality and safety but also helps you:

  • Identify and mitigate risks effectively.
  • Enhance operational efficiency and processes.
  • Improve product quality and customer satisfaction.

But how confident are you in your understanding of this critical standard? Can you effectively apply it to your organization’s Quality Management System (QMS)?

This ISO 13485 Internal Auditor training course equips you with the knowledge and skills to perform internal audits with confidence. You’ll learn industry-proven techniques and gain practical insights into applying the ISO 13485:2016 standard to real-world audit scenarios. The course covers the full audit process, including tools and preparation, opening meetings, interviews, closing meetings, and reporting, ensuring you have a comprehensive understanding of quality system auditing.

Whether you’re new to the quality field, expanding your expertise, or a seasoned professional, this course is designed to meet your needs. It provides foundational knowledge for beginners, advanced insights for experienced practitioners, and the latest best practices for industry veterans.

In this interactive, live-online course, our expert instructors emphasize practical application, using hands-on activities and case studies to reinforce your understanding of ISO 13485 requirements. You’ll leave the course with the skills and confidence to drive quality and compliance within your organization.

Pre-Requisites

There are no required prerequisites for this training.

This ISO 13485 Internal Auditor training course is beneficial for both quality novices and lifetime professionals.

All attendees are required to bring their own copy of the ISO 13485:2016 Quality Management Standard Requirements to this training course.

These will not be provided for you.

We strongly advise you bring a paper copy or an electronic copy that allows you to take notes.

ISO 13485 Internal Auditor Training - Close up of MRI results

Who Should Attend

  • Quality directors
  • Managers
  • Engineers
  • Auditors
  • ISO coordinators
  • Laboratory quality professionals
  • Anyone engaged in quality audits or quality assurance for medical devices

 

ISO 13485 Internal Auditor Training Objectives

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the ISO 13485:2016 requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements.
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews.
  7. Conduct audits that result in real improvements to the quality system.
  8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.
  9. Compare ISO 13485 to FDA 21 CFR 820 and the new Rule QMSR overview.

 

Agenda

Part 1: Introductions & Self-Assessment

  1. Course requirements
  2. How to get the most out of this experience
  3. Networking with industry professionals
  4. Self-assessment of audit skills and international standards
Part 2: Quality Terminology & Definitions

  1. Quality industry vernacular from ISO 9001, ISO 13485
  2. Differentiating between verification and validation
  3. Understanding corrective and preventive actions
  4. Medical device unique terms: clinical evaluation, advisory notice, complaint
  5. Activity #1: Terminology
Part 3: Requirements of ISO 13485:2016

  1. Demystifying the ISO 13485 standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of ISO 13485 to quality events
  5. Quizzes for the ISO 13485 Standard
  6. Activity #2: Case studies #1-#12
Part 4: The Audit Process: Roles & Duties

  1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  2. Qualifying Auditors
  3. Duties of the IA staff
  4. Role Play Audit #1: Prepare to perform an Internal Audit
Part 5: The Audit Process: Performing the Audit Process

  1. Audit Tools – checklists, process maps, findings, reports
  2. Conducting Audit Interviews
  3. Role Play Audit #1: Mock Audits with Classmates
Part 6: The Audit Process: Audit Skills & Techniques

  1. Audit Interviewing techniques
  2. Continual improvement techniques
  3. Developing a “continual improvement” attitude in the organization
  4. Activity #4: Writing Audit Findings
Part 7: The Audit Process: Finalizing the Audit

  1. Writing the audit report
  2. Opening and Closing Meetings
Part 8: Review of FDA 21 CFR 820

  1. Comparing FDA 21 CFR 820 paragraphs to the requirements of ISO 13485
  2. Evaluating the FDA requirements where significantly different from ISO 13485
  3. Activity #3: FDA Audit Cases #1-#15

 


Related Courses

ISO 13485 Lead Auditor Training – Recognized by Exemplar Global cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training MDSAP Training – Recognized by Exemplar Global ISO 9001 Lead Auditor Training – Recognized by Exemplar Global

cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training

 Days: 0.5 • CEU Hours: 0.6

 7:30 AM – 1:30 PM MST

Overview

The 2024 revision of FDA 21 CFR Part 820 marks a major shift in medical device quality system requirements, aligning more closely with ISO 13485:2016 through the new Quality Management System Regulation (QMSR). Understanding these changes is essential for maintaining compliance and avoiding costly delays as the 2026 enforcement deadline approaches.

QMSR applies to all FDA-regulated medical device manufacturers and introduces key updates that impact quality planning, documentation, audits, and risk management. It also reinforces the role of programs like MDSAP in supporting FDA compliance efforts.

This focused, half-day, live-online FDA 21 CFR Part 820 training delivers exactly what busy professionals need: a clear, practical overview of the new requirements and what they mean for your organization. You’ll learn what’s changing, what’s staying, and how to begin planning your transition immediately—with real examples and actionable guidance you can apply the same day. Whether you’re in quality, regulatory affairs, or executive leadership, this course will help you stay compliant, reduce risk, and move forward with confidence.

What You’ll Learn

  • The FDA’s announcement on February 2, 2024 to integrate ISO 13485:2016 into the new FDA 21 CFR 820 QMSR
  • New implementation timeline
  • Real examples of what’s new, and what is being removed or becoming obsolete
  • Examples of what is still required by FDA regulations until February 2026
  • The importance of getting started RIGHT NOW to create the Quality Manual, etc.
  • Medical Device Single Audit Model (MDSAP) and how impactful it can be to the QMS and audit program
FDA 21 CFR Part 820 - testing test tubes

Who Should Attend

  • ALL companies who make a medical device regulated by the FDA (Class I, II and III)
  • Top/Senior Management – Strategic Planners
  • Regulatory Management – Strategic and Tactical Planners
  • Regulatory Associates – Tactical – “Doers” of the work
  • Marketing Management – Strategic Planners and Post-Market Surveillance
  • Quality Managers and Associates
  • Auditors: Internal & 3rd Party external auditors
  • Consultants advising clients on making the upgrades to the new QMSR
  • Design and Development Engineers and Management
  • Product Risk Managers

 

FDA 21 CFR Part 820 QMSR Implementation Training Objectives

  1. Understand the primary changes from QSR to the QMSR
  2. Understand the importance of creating a Quality Plan to effectively plan for the changes
  3. Identify the necessary steps as to prepare an organization to transition to the QMSR requirement
  4. Understand the importance of MDSAP for your organization

 

Agenda

Part 1: High-level overview of the planned QMSR changes
Part 2: In-depth review of the planned QMSR changes
Part 3: Implementation timeline
Part 4: Strategy for deployment so the company’s QMS complies to the new QMSR regulation
Part 5: The importance of MDSAP
Part 6: Connecting with the appropriate Notified Body or Certification Body

 

Course Certificate

Participants will receive a cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation training certificate.

 


Related Courses

ISO 13485 Lead Auditor Training – Recognized by Exemplar Global Medical Device Single Audit Program (MDSAP) Training – Recognized by Exemplar Global ISO 13485 Internal Auditor Training – Recognized by Exemplar Global CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training

 

EU Medical Device Regulation (EU MDR) 2017/745 Training

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.5

 7:30 AM – 5:30 PM MST

 

Overview

In the complex world of medical device regulation, understanding and complying with the EU Medical Device Regulation (MDR 2017/745) is essential for maintaining product quality, ensuring patient safety, and achieving market access in the European Union. Manufacturers must navigate new requirements for technical documentation, risk management, device classification, and post-market surveillance, making MDR compliance both challenging and critical.

This live-online EU MDR Training for Medical Device Manufacturers provides an interactive, instructor-led learning experience where you can engage in real-time with expert instructors and industry peers. Unlike self-paced courses, this format allows for live discussions, Q&A sessions, and collaborative exercises, giving you the confidence and competence to apply MDR requirements effectively in your organization.

Recognized by Exemplar Global, this course equips you with the knowledge, tools, and strategies needed to navigate MDR compliance, including:

  • A complete overview of the EU MDR, including implementation timelines and paths to CE marking
  • In-depth exploration of the articles and annexes most relevant to manufacturers
  • Practical guidance on preparing technical documentation and conducting gap assessments
  • Understanding the impact of MDR requirements across the device lifecycle, from design and development to post-market surveillance

Through daily quizzes, practical tools, and interactive workshops on device classification, compliance scenarios, and real-world implementation examples, you’ll gain actionable skills that can be applied immediately. The live-online format fosters collaboration with other quality and regulatory professionals and ensures personalized guidance from expert instructors.

By the end of this training, you will leave with the confidence to lead your organization toward MDR compliance, navigate complex regulatory requirements, and avoid common pitfalls, all while earning a registered Exemplar Global certificate that validates your mastery of the course material.

Quizzes, Tools, Workshops

This is not a sit-and-listen course, and you will actively apply what you learn every day. Short quizzes help you confirm your understanding of key MDR concepts, while hands-on reviews of essential tools guide you through practical compliance steps.

You will explore resources such as the EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation Checklist, and comparison tools for ISO 13485:2016 and ISO 14971:2012 requirements.

To bring it all together, you will take part in interactive workshops focused on Device Classification, Compliance Scenarios, and real-world implementation exercises. You will leave ready to apply MDR principles in your own organization.

EU MDR - A Doctor Using a Centrifuge Machine

Who Should Attend

  • Auditors performing MDR or Quality/Regulatory System audits
  • Professionals guiding their organizations toward MDR compliance
  • Individuals who are frequently audited under MDR requirements
  • Quality & Regulatory Directors and Managers
  • Design and Process Engineers
  • ISO Coordinators
  • Laboratory Professionals
  • Risk Managers
  • Manufacturing Managers and Supervisors
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

This class is certified by Exemplar Global under their Exemplify process. Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global. EU MDR Training Recognized by Exemplar Global

 

EU MDR Training Objectives 

  1. Outline the primary changes that need to be addressed to Transition from MDD/AIMD compliance to MDR compliance
  2. Learn how to address the new MDR requirements.
  3. Describe and understand the objectives, terminology and structure of the MDR.
  4. Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier.
  5. Explain the impact of the new MDR requirements on economic operators (importers, authorized representatives) including manufacturers.
  6. Describe the different regulatory requirements through lifecycle of device, e.g. proof of concept, design and development, clinical evaluation, regulatory approval, manufacturing, postmarket/vigilance & end of life.
  7. Describe the increased requirements for risk management including risk benefit and state of the art.
  8. Plan a gap assessment to transition an organization to compliance.
  9. Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist).
  10. Identify the necessary step as to prepare an organization to transition to the MDR.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History, Overview & Terminology
Part 3: Overview of the MDR: Regulation (EU) 2017/745
 
Day 2
Part 1: Overview of the MDR: Regulation (EU) 2017/745
Part 2: Specific Application of MDR Regulation (EU) 2017/745
Part 3: Use of Harmonized Standards: ISO 13485 & ISO 14971
 
Day 3
Part 1: Compare MDD Essential Requirements to GSPR
Part 2: Summary of EU MDR Regulation
Part 3: EU MDR Transition Planning

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training ISO 14971 Training

Medical Device Single Audit Program (MDSAP) Training

 Certified by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 4:30 PM MST

Overview

Medical device companies face growing pressure to comply with multiple regulatory systems across different countries. The Medical Device Single Audit Program (MDSAP) streamlines this process by allowing one audit to satisfy the requirements of participating markets, including the U.S., Canada, Japan, Brazil, and Australia. But to fully benefit from MDSAP, organizations need qualified internal auditors who can apply the model effectively and drive meaningful quality improvements. That’s where this training comes in.

This training course is certified by Exemplar Global and gives you the tools and skills to audit Quality Management Systems in alignment with MDSAP and ISO 13485. Taught live-online over three days, this interactive course is designed for professionals at all experience levels.

Through practical exercises and real-world case studies, you’ll learn to conduct effective audits using the audit model. You’ll follow the complete audit process, from planning and preparation to closing meetings and reporting, while developing the confidence to interpret and apply requirements in real audit scenarios.

Rather than focusing on theory, this course emphasizes hands-on learning. You’ll gain practical techniques for conducting interviews, identifying audit evidence, and uncovering opportunities for true quality system improvement.

Whether you’re responsible for audits, preparing for MDSAP certification, or supporting your organization’s compliance efforts, this course equips you to perform internal audits that add value.

Prerequisites

There are no required prerequisites for this training, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.

This MDSAP training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

MDSAP training - Looking at x-rays

Who Should Attend

  • Quality Managers
  • Audit Program Managers
  • Internal and external auditors
  • Management Representatives
  • Project Teams
  • Individuals assisting their organizations toward ISO 13485 registration

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Recognized Training Provider.

This MDSAP training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Exemplar Global RTP Certified badge

 

MDSAP Training Objectives 

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Understand the MDSAP audit model.
  3. Understand and interpret the ISO 13485 requirements and review applicable MDSAP requirements.
  4. Apply the proper interpretation of the standard in actual audit situations.
  5. Understand process auditing tools leading to substantive quality system improvements.
  6. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  7. Follow-up and resolve audit trails that present themselves during the audit interviews.
  8. Conduct audits that result in real improvements to the quality system.
  9. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Day 1
Part 1: Course & Student Introductions
Part 2: Introduction to Audit Approach
Part 3: Terminology
Part 4: Activity #1: Lingo
Part 5: Audit Approach Chapter 1
Part 6: In-Class Chapter 1 Audit
Part 7: Annex I: Technical Documentation
Part 8: MDSAP Audit: Chapter 2,3,4
Part 9: Activity #2: Chapter 2 – Registration
Part 10: Activity #3: Measurement & Analysis
Part 11: Activity #4: Adverse Events Reporting
 
Day 2
Part 1: Understanding ISO 13485
Part 2: Activity #5: Quality Audit Scenarios
Part 3: MDSAP Audit: Chapter 5 D&D, 6 Production, 7 Purchasing
Part 4: Activity #6: In-Class Design Process Audit
Part 5: Activity #7: Prepare to be Audited
Part 6: Activity #8: Prepare for Mock Audit
Part 7: Activity #9: Perform Mock Audit Part 1
 
Day 3
Part 1: Activity #9: Perform Mock Audit Part 2
Part 2: Audit Debrief
Part 3: Cont. Audit Findings and Classification ISO
Part 4: MDSAP Audit Administration
Part 5: Audit Duration Calculation
Part 6: Non-Conformities
Part 7: In Class #10: Impact of NCs
Part 8: In Class #11: Final grading NCs
Part 9: Post-Audit Activities
Part 10: Writing Nonconformity Statements
Part 11: Activity #12: Write NCs and Grade
Part 12: Final Exam

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training ISO 14971 Training EU Medical Device Regulation (EU MDR) Training

Lead Auditor Medical Device Single Audit Program MDSAP Training

 Certified by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 4:30 PM MST

Overview

Medical device companies face increasing pressure to comply with multiple regulatory systems worldwide. The Medical Device Single Audit Program MDSAP helps streamline compliance by allowing one audit to meet the requirements of key markets, including the U.S., Canada, Japan, Brazil, and Australia. To take full advantage of MDSAP, organizations need highly skilled lead auditors who can manage audit teams, interpret requirements confidently, and deliver results that drive real quality improvements.

This Exemplar Global–certified training course equips you with the knowledge, skills, and credentials to perform and lead audits of Quality Management Systems against MDSAP and ISO 13485 requirements. Delivered live-online over four days, the course combines expert instruction with interactive learning to prepare professionals to take on the responsibilities of a lead auditor.

Through practical exercises, roleplay, and real-world case studies, you’ll gain hands-on experience in planning, conducting, reporting, and following up on audits. You’ll also develop advanced competencies in leading audit teams, managing communication with auditees, and making sound decisions about nonconformities.

Rather than focusing solely on theory, this course emphasizes applied learning. You’ll practice techniques for conducting interviews, analyzing evidence, grading nonconformities, and writing clear nonconformity statements, all while simulating the full audit process.

Whether you’re preparing for MDSAP certification, leading compliance efforts, or expanding your career as a professional auditor, this training provides the foundation and confidence to perform effective, value-added audits as a certified lead auditor.

Prerequisites

There are no required prerequisites for this training, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.

This MDSAP training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

Medical Device Single Audit Program MDSAP training - People in a lab

Who Should Attend

  • Quality Managers
  • Audit Program Managers
  • Internal and external auditors
  • Management Representatives
  • Project Teams
  • Individuals assisting their organizations toward ISO 13485 registration

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Recognized Training Provider.

This MDSAP training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Exemplar Global RTP Certified badge

 

Lead Auditor Medical Device Single Audit Program MDSAP Training Objectives 

  1. Understand how to apply and audit the requirements of ISO 13485.
  2. Understand the MDSAP Audit Approach and auditing process.
  3. Understand the country-specific requirements.
  4. Prepare audit checklists based on Medical Device Single Audit Program MDSAP audit tasks and ISO 13485 requirements.
  5. Understand how to grade nonconformities and write nonconformity statements for a Medical Device Single Audit Program MDSAP audit.

 

Agenda

Day 1
Part 1: Course & Student Introductions
Part 2: Introduction to MDSAP Audit Approach
Part 3: Medical Device Single Audit Program MDSAP Terminology
Part 4: Activity #1: Lingo
Part 5: Audit Approach Chapter 1
Part 6: In-Class Chapter 1 Audit
Part 7: Annex I: Technical Documentation
Part 8: Auditing Principles – ISO 19011
 
Day 2
Part 1: Auditing Principles – ISO 19011 cont.
Part 2: Audit Roleplay #1: Corrective Action
Part 3: MDSAP Audit: Chapter 2,3,4
Part 4: Activity #2: Chapter 2 – Registration
Part 5: Activity #3: Measurement & Analysis
Part 6: Activity #4: Adverse Events Reporting
 
Day 3
Part 1: Understanding ISO 13485
Part 2: Activity #5: Quality Audit Scenarios
Part 3: MDSAP Audit: Chapter 5 D&D, 6 Production, 7 Purchasing
Part 4: Activity #6: In-Class Design Process Audit
Part 5: Activity #7: Prepare to be Audited
Part 6: Activity #8: Prepare for Mock Audit
Part 7: Activity #9: Perform Mock Audit Part 1
 
Day 4
Part 1: Activity #9: Perform Mock Audit Part 2
Part 2: MDSAP Audit Administration
Part 3: Medical Device Single Audit Program MDSAP Non Conformities
Part 4: In Class #10: Impact of NCs
Part 5: In Class #11: Final grading NCs
Part 6: Post-Audit Activities
Part 7: Writing Nonconformity Statements
Part 8: Activity 12: Write NCs and Grade
Part 9: Final Exam

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training ISO 14971 Training EU Medical Device Regulation (EU MDR) Training

ISO 14971 Training – Application of Risk Management to Medical Devices

 Certified by Exemplar Global

Days: 2 • CEU Hours: 1.6

 7:30 AM – 4:30 PM MST

Overview

Effectively managing risk is essential to ensuring the safety, performance, and compliance of medical devices. ISO 14971 outlines the international standard for medical device risk management, and understanding how to apply it is critical for organizations across the industry.

This live-online ISO 14971 training course is certified by Exemplar Global and offers a practical, hands-on approach to implementing risk management using ISO 14971:2019 and ISO/TR 24971:2020. Over two interactive days, participants will explore how to identify hazards, evaluate risk, implement controls, and maintain a comprehensive risk management process throughout the product lifecycle.

Whether you are new to risk management or looking to deepen your expertise, this course is designed to meet you at your current level and build your confidence through expert instruction and real-world case studies.

By the end of the course, participants will be able to:

  • Understand the structure and requirements of ISO 14971 and ISO/TR 24971
  • Apply risk analysis tools and techniques to medical device scenarios
  • Develop and document effective risk management plans
  • Integrate risk management into quality systems and design activities
  • Monitor, review, and improve risk-related processes over time

Risk isn’t optional, and neither is compliance. This ISO 14971 training gives you more than a theoretical understanding of ISO 14971. It empowers you with practical skills that you can apply immediately in your role to reduce risk, improve product safety, and support regulatory readiness. Whether you’re preparing for audits, contributing to design decisions, or building risk files, this training will help you do it with confidence and credibility.

Prerequisites

There are no required prerequisites for this training.

This ISO 14971 training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students should bring their own printed copy of the ISO 14971:2019 and ISO/TR 24971:2020 standards.

The course provides an overview of these documents, but having your own copy to follow along with will be a powerful learning aid.

ISO 14971 training - weighing an object on a scale

Who Should Attend

  • Quality Managers
  • Engineering Managers
  • Audit Program Managers
  • Internal and external auditors
  • Design Teams
  • Management Representatives
  • Project Teams
  • Anyone who needs to understand the difference between Risk Identification, Risk Assessment, and Risk Management and how to put these important tools to work for your organization

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Recognized Training Provider.

This ISO 14971 training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Exemplar Global RTP Certified badge

 

 

ISO 14971 Training Objectives 

  1. Learn the requirements of risk-based thinking.
  2. Learn the principles of managing Risk.
  3. Understand how to develop a framework for Risk Management.
  4. Understand how to develop a process for Risk Management.
  5. Interpret ISO Standards related to device risk: ISO 14971:2019 and ISO/TR 24971:2020.
  6. Apply the Risk Management Process & Tools to real risk situations.

 

Agenda

Day 1
Part 1: Risk Terminology and Theory from ISO 14971 and ISO 13485
Part 2: History of Risk Management and Relationship with Corrective and Preventive Actions
Part 3: Requirements of ISO 14971
Part 4: Selection of Risk Treatment Options
Part 5: Preparing and Implementing Risk Treatment Plans
Part 6: Monitoring and Review
Part 7: Recording the Risk Management Process
Part 8: Internal & External Framework, Risk Treatment, Risk Monitoring, Risk Policy, Risk Analysis
 
Day 2
Part 1: Guidelines from ISO 14971
Part 2: Techniques – Risk Management
Part 3: Case Studies with Application
Part 4: Organization’s Risk Procedures and Tools
Part 5: Risk Applications for Medical Devices
Part 6: Case Studies with Application
Part 7: Statistical Methods
Part 8: Test

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training Medical Device Single Audit Program (MDSAP) Training EU Medical Device Regulation (EU MDR) Training

AS13004 Training – PFMEA Risk Management

Days: 2

 7:30 AM- 4:30 PM MST

 

Overview

When a single failure can ground a fleet or compromise safety, aerospace manufacturers must get risk management right the first time. AS13004 offers a proven, structured approach to identifying and controlling process risks before they result in costly nonconformities, escapes, or customer dissatisfaction.

This focused, two-day AS13004 PFMEA Risk Management Training equips aerospace professionals with the tools and methods needed to identify, assess, and mitigate risk throughout the production process. This course directly supports compliance with AS9100, AS9120, and AS13004 by focusing on the practical application of PFMEA and Control Plan development as key elements of a proactive risk management strategy.

Led by instructors with deep industry experience, this course covers:

  • The four-step risk management process outlined in ISO 31000.
  • How ISO 9001 and AS9100 define and expect Risk-Based Thinking.
  • Use of aerospace-specific tools: Process Flow Diagrams, PFMEAs, and Control Plans.
  • How to quantify and prioritize risk for more effective decision-making.
  • Applying AS13004 methodology to meet Operational Risk Management requirements.

Through case studies, interactive exercises, and detailed walkthroughs, participants will gain hands-on experience developing PFMEAs and Control Plans that reduce variability, improve product safety, and strengthen compliance across the aerospace supply chain.

What You Will Learn  

  • How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
  • How to address the Operational Risk Management requirements of AS9100 (per AS13004).
  • Tools used for Risk Assessment such as DFMEA, Process Flow Diagrams, PFMEAs and Control Plans.
  • How risk management can be applied to any organization, regardless of its products or customers.
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed.
  • How to quantify risk as the first step in establishing priorities for your organization.
  • Methods for controlling risks within your Supply Chain.
AS13004 Training - Three people working and pointing to papers

Who Should Attend

  • Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
  • Organizations that must meet the requirements–AS9100 Operational Risk Management, and AS13004 PFMEA and Control Plans.
  • Quality Managers
  • Management Representatives
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Project Teams

 

AS13004 Training Objectives

  1. Understand the requirements of AS13004.
  2. Apply the principles of managing Risk using the PFMEA tool.
  3. Understand the process of how to develop good process risk management using: Process Flow Diagram, PFMEA and Control Plans.
  4. Apply the Risk Management Process & Tools to real risk situations

 

Agenda

Day 1
Part 1: Risk terminology
Part 2: Four-Step Risk Management Process Outlined in ISO 31000
Part 3: Risk-Based Thinking Requirements of ISO 9001:2015 and AS9100D
Part 4: Strategic vs. Process Risk Management
Part 5: Tools, Methods, and a Streamlined Approach for Addressing Risk-Based Thinking Requirements
Part 6: Hands-On Exercises
 
Day 2
Part 1: Aerospace Risk Terminology
Part 2: Overview of APQP and PPAP Risk Tools: Process Flow Diagrams, PFMEA’s and Control Plans
Part 3: How to Develop a Process Flow Diagram (Identifying Process Risks)
Part 4: Guidelines for Performing a Process Failure Modes and Effects (FMEA) Analysis
Part 5: Creating an Effective Control Plan used to Manufacture and Control and Resolve Ongoing Process Risks
Part 6: Detailed Hands-On Case Study Developing an FMEA analysis, With Tools for Completing Each Stage
Part 7: Requirements for Operational Risk Management
Part 8: Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans
Part 9: Guidance on using AS13004 Methodology to Meet Operational Risk Management Requirements

 


Related Courses

Root Cause Analysis & Corrective Action Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training AS9100 Lead Auditor Training – Certified by Probitas Supplier Audit Training

 

AS13000 Training (8-D): Root Cause & Corrective Action for Aerospace

Days: 2

 7:30 AM- 4:30 PM MST

 

Overview

In the aerospace industry, effective problem-solving is critical to ensuring product quality, customer satisfaction, and long-term supplier relationships. Suppliers to top OEMs are required to have trained 8-D practitioners to lead robust corrective and preventive actions. The AS13000 Training (8-D): Root Cause & Corrective Action for Aerospace equips participants with the standardized skills and tools needed to meet this essential requirement.

This two-day live-online course provides a comprehensive, hands-on approach to the AS13000 standard, which defines problem-solving requirements for the aero-engine sector. Using the Eight Disciplines (8D) methodology as its foundation, the course covers each discipline in detail and emphasizes practical application through real-world case studies. Participants will learn to identify root causes, implement effective corrective actions, and reduce the risk of problem recurrence, helping to minimize costs associated with poor quality and support a culture of zero defects.

Led by experienced instructors, the course includes interactive exercises that develop skills in team dynamics, stakeholder management, and problem-solving tool application. Students will practice completing AS13000 8-D templates, leading problem-solving activities, and applying proven techniques such as Fishbone (Ishikawa) analysis, 5W2H, Pareto analysis, and control charts.

By the end of this training, participants will be prepared to lead and facilitate 8-D problem-solving activities that meet AS13000 requirements. They will gain the knowledge, confidence, and practical skills necessary to strengthen corrective action processes, improve quality outcomes, and maintain compliance with top OEM standards.

What You Will Learn  

  • Lead and facilitate 8-D problem-solving activities to AS13000 standards.
  • Complete an AS13000 8-D Problem Solving template.
  • Apply a comprehensive problem-solving toolkit.
  • Define problems using 5W2H and other root cause techniques.
  • Conduct root cause analysis using Fishbone (Ishikawa) diagrams and Pareto charts.
  • Address team dynamics and manage challenging participants effectively.
  • Practice stakeholder and customer communication during problem-solving.
  • Implement corrective and preventive actions to reduce risk of recurrence.
  • Apply lessons through real-world case studies and hands-on exercises.
AS13000 Training - Airplane engine

Who Should Attend

  • Employees responsible for conducting corrective actions
  • Team members participating in corrective action or problem-solving teams
  • Quality Managers and Management Representatives
  • Engineering and Project Managers
  • Design and Development Teams
  • Internal and External Auditors
  • Continuous Improvement or Lean/Six Sigma Practitioners
  • Any individual seeking a deeper understanding of structured problem-solving using the 8-D methodology

 

AS13000 Training Objectives

  1. Lead and Facilitate an 8D Problem Solving Activity to AS13000 Requirements.
  2. Complete an AS13000 8D Problem Solving Template.
  3. Apply a Problem-Solving Toolkit.
  4. Recognize and deal with issues of Team Dynamics and Challenging People.
  5. Practice Effective Customer / Stakeholder Management.
  6. Reduce Risk of Problem Recurrence.

 

Agenda

Day 1
Part 1: Introduction & 8-D Practitioner Requirements
Part 2: Problem Solving Terminology and Definitions
Part 3: Activity #1: Standard Terminology
Part 4: Review of Standard
 
Day 2
Part 1: Activity #2.1: 5W2H Define the Problem – Circuit Boards
Part 2: Activity #2.2: Define the Problem 8-D form
Part 3: Activity #2.3: PCB CAR Review/8-D D2 & D3
Part 4: Activity #3.1: Ishikawa – Fishbone

 


Related Courses

Root Cause Analysis & Corrective Action Training AS9102 First Article Inspection Training AS9100 Lead Auditor Training – Certified by Probitas Supplier Audit Training

 

CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training

Days: 2 • CEU Hours: 1.6

 7:30 AM – 4:30 PM MST

Learn Root Cause Investigation & CAPA in Medical Devices & Pharmaceuticals.

 

Overview

Corrective and preventive action (CAPA) failures are among the most common—and most costly—issues cited by the FDA. For medical device and pharmaceutical companies, an ineffective CAPA system can trigger major compliance problems, regulatory scrutiny, and product risks. But when done right, CAPA in medical devices becomes a powerful driver of quality improvement and risk reduction.

This practical, two-day live-online training equips you with the skills and tools to build and maintain a compliant, effective CAPA system in line with FDA 21 CFR and ISO 13485 requirements. Designed specifically for professionals in medical device and pharmaceutical industries, the course teaches you how to perform efficient root cause investigations and develop corrective actions that truly solve problems and prevent recurrence.

Led by experts in medical device and pharma compliance, this course covers:

  • Key CAPA requirements from 21 CFR Parts 4, 820, 210/211, 201/801, and ISO 13485.
  • EU MDR expectations, including Article 83 (PMS), Article 89 (Serious Incidents), and Article 10 (Manufacturing).
  • Fast-paced, fact-based investigation tools including 5 Whys, Fault Tree Analysis, and Fishbone Diagrams.
  • Real-world case studies that walk through containment, root cause analysis, corrective action planning, and verification of effectiveness.
  • Practical tips for documenting CAPA activities to meet global regulatory expectations.
  • Risk management tools like FMEA and incident risk analysis to enhance the impact of your CAPA system.

Whether you’re responding to complaints, audit findings, or internal quality events, you’ll leave this course with the confidence to manage CAPA in medical devices and pharmaceuticals with clarity, consistency, and compliance.

Topics

  • The regulatory requirements for CAPA in medical devices and pharmaceuticals.
  • How to perform effective fast-paced root cause analysis and complaint investigations.
  • How to document complaint investigations and maintain records to demonstrate compliance.
  • Root cause investigation methods, such as:
    • The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys)
    • Fault Tree Analysis
    • Cause and Effect
    • Flow Charting
    • Pareto Charting
    • Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)
  • Other helpful pharma & medical device CAPA Tools including:
    • 5-W 2-H and 5-W 2-H Proof
    • FMEA
    • Containment approaches
    • Incident Risk Analysis
    • Paynter Charts
    • Layered Process Auditing
    • Corrective Action Plans
    • COPQ approach to CAPA profit enhancement
CAPA in Medical Device - Woman opening a machine with vials

Who Should Attend

  • Quality Engineers (QE)
  • Manufacturing Engineering (ME)
  • Process Engineers & Technicians
  • Electrical Engineers (EE) and Technicians
  • Top Management – They are ultimately responsible for ensuring the CAPA system is working effectively.
  • Operations Directors & Management
  • Engineering Directors & Management
  • Manufacturing Directors & Management
  • Regulatory Directors & Management
  • Quality Assurance Directors & Management
  • Purchasing Managers
  • Supply Chain Managers who deal with SCAR and CAR processes

 

Training Objectives For CAPA in Medical Devices

  1. Practice within a compliant corrective action & preventive action (CAPA) process.
  2. Perform effective root cause investigations.
  3. Understand when and how to apply the appropriate root cause investigation tool/method.
  4. Understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
  5. Establish effective corrective action plans.
  6. Plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
  7. Understand how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
  8. Understand how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
  9. Understand the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques.

 

Agenda

Day 1
Part 1: Overview – Why CAPA in Medical Devices are Required
Part 2: Typical Problems with Root Cause Investigations
Part 3: Responsibilities for Root Cause and Corrective/Preventive Action
Part 4: Step 1: Assigning a Corrective Action Team Leader: Cross-Functional Team
Part 5: Step 2: Describing the Problem – COPQ
Part 6: Step 3: Containing the Problem
Part 7: Step 4: Identifying the Root Cause or Causes
Part 8: Data Collection and Analysis
 
Day 2
Part 1: Step 5: Verifying the Root Cause or Causes
Part 2: Step 6: Implementing Corrective Actions
Part 3: Step 6a: Risk Assessment: Verify CAPA Does Not Impact Regulatory or Safety Requirements
Part 4: Step 7: Verifying Corrective Action Effectiveness
Part 5: Step 8: Closing the Corrective Action
Part 6: Course Insights and Final Exam

 


Related Courses

ISO 13485 Lead Auditor Training – Recognized by Exemplar Global cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training MDSAP Training – Recognized by Exemplar Global ISO 14971 Training –  Recognized by Exemplar Global

 

Root Cause Analysis, Corrective Action and Preventive Action CAPA Training

Days: 2

 7:30 AM- 4:30 PM MST

 

Overview

Mistakes happen and processes fail, but unresolved issues and recurring problems can lead to wasted resources, compliance risks, and operational inefficiencies. It’s important for organizations to have effective root cause analysis procedures in order to ensure that these issues are corrected and prevented in the future.

To help organizations tackle these challenges, Axeon’s Root Cause Analysis & CAPA training provides a structured, 8-step approach to Root Cause Analysis (RCA), Corrective Action, and Preventive Action (CAPA). This course applies to any industry or organization looking to improve problem-solving effectiveness. It emphasizes proven methodologies for identifying root causes, implementing corrective actions, and preventing recurrence, all while ensuring compliance with quality management system requirements.

Using industry-recognized tools such as Five Whys, Ishikawa diagrams, and Failure Modes and Effects Analysis (FMEA), this Root Cause Analysis & CAPA training course provides a practical framework for improving process reliability and sustaining long-term improvements.

Available both online and in-person, this interactive course combines expert instruction with hands-on exercises and real-world case studies. Whether you’re new to corrective actions or looking to refine your approach, this training will equip you with the skills needed to drive meaningful improvements in your organization.

Root Cause Analysis & CAPA Training Key Topics  

  • Root Cause Analysis fundamentals and common challenges
  • Systematic problem description and containment strategies
  • Data-driven tools for identifying and verifying root causes
  • Developing and implementing effective corrective actions
  • Layered Process Audits and verification methods
  • Preventing recurrence and closing corrective action reports
CAPA Training - Two men working on a white board

Who Should Attend

  • Employees responsible for conducting or managing corrective actions
  • Quality managers, engineers, and auditors involved in CAPA processes
  • Supervisors and frontline managers overseeing process improvements
  • Production and operations personnel responsible for identifying and resolving issues
  • Regulatory and compliance professionals ensuring adherence to quality standards
  • Team members involved in problem-solving initiatives or process improvement projects
  • Anyone seeking a structured approach to root cause analysis and corrective action

 

Root Cause Analysis & CAPA Training Objectives

  1. Understand the ISO requirements for Corrective Action, Risk-Based Thinking, and/or Preventive Action.
  2. Experience a variety of tools and methods for performing Root Cause Analysis (RCA).
  3. Learn a variety of methods and tools for performing effective Corrective Actions.
  4. Understand when a full RCA is necessary or when an Apparent Cause Analysis or Correction Only is preferred.

 

Agenda

Day 1
Part 1: Introductions
Part 2: Terminology & Definitions
Part 3: ISO Standard Requirements
Part 4: Incident Investigation & Risk Assessment
Part 5: 8D Corrective Action Methodology & Case Study
Part 6: 8D Root Cause & Corrective Action (Part 1)
 
Day 2
Part 6: 8D Root Cause & Corrective Action (Part 1 Continued)
Part 7: Human Factors
Part 8: 8D Root Cause & Corrective Action (Part 2)
Part 9: Real-World Case Study
Part 10: Final Exam

 


Related Courses

CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training ISO 9001 Lead Auditor Training Human Factors Training

Software & Process Validation Training

 Certified by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 4:30 PM MST

Overview

In today’s highly regulated life sciences industries, failing to properly validate processes or software can lead to costly recalls, regulatory scrutiny, and compromised product quality. Whether it’s a new medical device, pharmaceutical process, or automated system, organizations need robust validation programs to ensure safety, effectiveness, and compliance. The Software and Process Validation Training equips professionals with the practical knowledge and skills required to meet these critical requirements.

This three-day live online course provides a comprehensive understanding of process and software validation across the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical, and Cosmetic industries. You will learn how to design, plan, and execute validation programs that align with regulatory expectations from the FDA, ISO 13485, ISO 14971, and GHTF guidance. Through expert instruction, real-world case studies, and interactive exercises, participants will gain hands-on experience developing validation protocols, implementing IQ, OQ, and PQ, and maintaining validated systems over time.

The course also covers software validation, including FDA guidance, the classic V Model, software requirements development, verification and validation testing, defect prevention, and validation of automated and COTS systems. Participants will complete exercises such as validation master planning, protocol development, process capability assessments, and software testing scenarios to reinforce learning.

This class is certified by Exemplar Global, and participants who complete all sessions and exercises will receive a registered certificate recognized worldwide. With this training, you will gain the confidence and practical expertise to lead or support a compliant validation program, ensuring your processes and software consistently deliver safe, effective, and regulatory-compliant results.

Topics Covered

  • Process validation principles and regulatory requirements

  • Validation protocols: IQ, OQ, PQ

  • Master Validation Plan and planning elements

  • Statistical methods and process capability

  • Managing deviations and maintaining validation

  • Software validation principles and lifecycle

  • FDA guidance, V Model, and defect prevention

  • IQ, OQ, PQ testing for software

  • Validation of automated and COTS systems

  • Documentation, traceability, and post-change validation

  • Protocol development and case studies

  • Installation, operational, and performance qualification exercises

  • Software testing exercises and traceability matrix

Software & process validation - heart monitor

Who Should Attend

  • Those responsible for planning and operating a compliant process and software validation program
  • Process Engineers
  • Operations Personnel
  • Quality Personnel
  • Regulatory Personnel
  • R&D
  • Design Engineers
  • Product Formulators

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Recognized Training Provider.

This Process & Software Validation training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Exemplar Global RTP Certified badge

 

Software & Process Validation Training Objectives 

  1. Understand and explain the key concepts of Process Validation and how it applies to the Life Cycle of a medical device.
  2. Differentiate the regulatory and quality requirements for: Process Validation, Software Validation and Design Validation
  3. Study the requirements of a Validation Protocol including: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
  4. Identify and understand the primary guidance documents for performing Process Validation.
  5. Review case studies of Process Validations and learn how to develop: A Validation Master Plan (VMP), a Validation Protocol (VP) and implement IQ/OQ/PQ

 

Agenda

Day 1
Part 1: Course & Student Introductions
Part 2: Concepts & Requirements
Part 3: Validation Terminology
Part 4: Review the Guidance SG-3
Part 5: 3 Process to be validated / 4 Statistical Methods & Annex A 1-3
Part 6: 5.1 Starting / Validation Master Plan
Part 7: 5.2 Validation Protocol / 5.3IQ / 5.4 OQ
Part 8: Validation Master Plan Template
 
Day 2
Part 1: Validation Protocol
Part 2: 5.5 PQ/ 5.5 Maintaining -Revalidation / 5.6 Report / 6 Monitoring: state of control, Revalidation
Part 3: PQ Template
 
Day 3
Part 1: CDRH Jan. 2002 Software Validation FDA Guidance
Part 2: Validation Tasks/Software Developer Testing/Manufacturer Testing
Part 3: S/W Validation – Regulatory D&D S/W Standard/510k Documentation Requirements
Part 4: ISO EN 62304 S/W Life Cycle Processes
Part 5: 10-Steps to S/W Validation

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training ISO 14971 Training EU Medical Device Regulation (EU MDR) Training

In Vitro Diagnostic Regulation (IVDR) 2017/746 Training

 Certified by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 4:30 PM MST

Overview

The transition to the In Vitro Diagnostic Regulation (IVDR 2017/746) marks a major shift for medical device manufacturers in the European market. Under the IVDR, all existing in vitro diagnostic devices must be recertified to meet new, more rigorous requirements. There are no grandfathering provisions, so understanding and implementing these changes is essential for continued market access and compliance.

This live-online training for medical device manufacturers provides a comprehensive, hands-on look at the regulation and its practical application. You will explore the requirements’ structure, timelines, and paths to CE marking, along with the significant articles and annexes that impact manufacturers most. Through expert instruction, practical examples, and interactive workshops, you will gain the knowledge and tools to navigate the transition from IVDD to IVDR with confidence.

Led by experienced instructors, this three-day course covers:

  • A full overview of IVDR requirements, implementation timelines, and CE marking pathways
  • Detailed discussion of key articles and annexes, including their organization and application
  • Practical guidance on performing gap assessments and preparing Technical Documentation
  • Understanding expanded requirements for risk management, performance evaluation, and post-market surveillance
  • Comparison of IVDR requirements to ISO 13485:2016 and ISO 14971:2019 standards

Recognized by Exemplar Global through their Exemplify process, this course awards a registered certificate to participants who complete all sessions, pass the quizzes, and demonstrate mastery of the workshops. By the end of this training, you will have a clear understanding of the requirements and the practical steps needed to achieve and maintain compliance. You will leave prepared to guide your organization through the transition with confidence and ensure continued access to the European market.

Included Documents

In addition to a slide presentation, activities, and quizzes, this class includes the following documents for students to utilize in their positions:

  •  Copy of the IVDR
  • IVDR gap analysis template
  • General Safety and Performance Requirements (GSPR) checklist
  • Technical Documentation Checklist
IVDR training - Man looking at test tube of blood

Who Should Attend

  • Individuals performing audits to IVDR or Quality/Regulatory Management Systems
  • Professionals guiding their organizations toward compliance
  • Individuals who are frequently audited under IVDR requirements
  • Quality and Regulatory Directors and Managers
  • Design and Process Engineers
  • Auditors and ISO Coordinators
  • Laboratory Professionals
  • Risk Managers
  • Manufacturing Managers and Supervisors

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Recognized Training Provider.

This IVDR training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Exemplar Global RTP Certified badge

 

IVDR Training Objectives 

  1. Outline the primary changes that need to be addressed to Transition from IVDD compliance to IVDR compliance.
  2. Practical guidance on how to address the new requirements.
  3. Describe/Understand the objectives, terminology and structure of the requirements.
  4. Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier.
  5. Explain the impact of the new requirements on economic operators (importers, authorized representatives) including manufacturers.
  6. Describe the different regulatory requirements through lifecycle of device, e.g. proof of concept, design and development, clinical evaluation, regulatory approval, manufacturing, postmarket/vigilance & end of life.
  7. Describe the increased requirements for risk management including risk benefit and state of the art.
  8. Plan a gap assessment to transition an organization to compliance.
  9. Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist).
  10. Identify the necessary step as to prepare an organization to transition.

 

Agenda

Day 1
Part 1: Course & Student Introductions
Part 2: History, Overview & Terminology
Part 3: Quality Terminology
Part 4: IVDR Major Changes from IVDD
Part 5: Quiz 1: Major Changes
Part 6: Overview of the IVDR: Regulation (EU) 2017/746
 
Day 2
Part 1: Overview of the IVDR: Regulation (EU) 2017/746
Part 2: Quiz 2: Requirement Chapters
Part 3: Specific Application of IVDR Regulation (EU) 2017/746
Part 4: Activity 3: Device Classification
Part 5: Use of Harmonized Standards: ISO 13485 & ISO 14971
Part 6: State of the Art
Part 7: Activity 4: In-Class Review of GSPR Checklist
 
Day 3
Part 1: Activity 5: Compare MDD Essential Requirements to GSPR
Part 2: Activity 6: Technical Documentation Checklist
Part 3: Summary of Regulation
Part 4: Activity 7: Transition Planning
Part 5: Activity 8: Scenarios
Part 6: Step-By-Step Guide to Complying

 


Related Courses

ISO 13485 Lead Auditor Training cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training ISO 14971 Training EU Medical Device Regulation (EU MDR) Training

AS13100 Rev A AESQ Supplemental QMS Requirements Training

Days: 3 • CEU Hours: 2.4

7:30 AM – 4:30 PM

 

Overview

In the aerospace engine industry, delivering consistent, high-quality products isn’t just a competitive advantage. It’s a customer expectation. The AS13100 Revision A standard, released in April 2025, brings updated requirements to help suppliers streamline compliance across multiple OEMs while improving quality and reducing variation.

Developed by the Aerospace Engine Supplier Quality (AESQ) Strategy Group, AS13100 harmonizes customer-specific requirements and translates them into a unified framework that suppliers can implement with clarity and consistency. The new revision includes important clarifications, expanded guidance on defect prevention, and updated expectations around measurement systems analysis, process control, and first article inspection.

This interactive, live-online course is designed for aerospace suppliers looking to understand and implement the latest requirements and associated AESQ Reference Manuals (RMs). Whether you’re already certified to AS9100 or just beginning your journey, this training equips you with the knowledge and tools to integrate AS13100 into your QMS effectively.

Led by experienced instructors, you’ll explore how AS13100 aligns with AS9100 and AS9145, with a strong emphasis on Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), and Core Quality Tools. You’ll also learn how to translate AS13100 into actionable requirements within your own organization and supply chain, ensuring compliance, improving audit readiness, and supporting long-term quality performance.

Topics

AESQ AS9100 Supplemental Requirements for: Strategic Planning, Top Management, Competence & Awareness, Risk Management, Monitoring Equipment, Human Factors, Design & Development, Supply Chain Management & Control, Manufacturing Systems, Internal Audits, and Corrective Action

AESQ AS9145 Supplemental Requirements for: APQP – Project Management, Design & Development, Process Design & Development, Validation of Products and Processes; PPAP – File Submission and Disposition, Supply Chain PPAPAESQ

Core Defect Prevention Quality Tools:  DFMEA, PFMEA, Key Characteristics, Process Flow Diagrams, Control Plans, MSA, Capability Studies

AS13100 - Nose of jet with sunset in background.

Who Should Attend

  • Quality Managers
  • Management Representatives
  • Senior Managers & Management Representatives
  • AS13100 Implementation Teams: Quality, Operations, Engineering, Regulatory, etc.
  • Functional Leaders impacted by AS13100: Design, Manufacturing, Engineering, Operations, Purchasing, Program Management, Sales
  • Internal Auditors

 

Training Objectives

  1. Understand the requirements of the AS13100 standard.
  2. Apply the standard requirements.
  3. Identify Standards and Handbooks referenced in the standard and overview these guidance materials.
  4. Review and practice related to Reference Manuals:
    1. RM13000 Problem Solving Methods including 8D
    2. RM13002 Alternate Inspection Frequency Plans
    3. RM13003 Measurement Systems Analysis (MSA)
    4. RM13004 Defect Prevention Quality Tools to support APQP and PPAP
    5. RM13005 Quality Audit Requirements
    6. RM13006 Process Control Methods
    7. RM13007 Sub Tier Management
    8. RM13008 Design Work
    9. RM13009 AS13100 Compliance Matrix
    10. RM13010 Human Factors
    11. RM13011 Rework and Production Repair of NC Products
    12. RM13102 First Article Inspection
    13. RM13145 APQP and PPAP within Aerospace
  5. Enhance understanding of Tools and RMs.
  6. Understand the Core Tools, including: Design FMEA, Process Flow Diagrams, Process FMEA, Production Control Plans, Measurement Systems Analysis, and Process Capability Studies.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: History, Purpose, Related Publications (SAE/AESQ/ISO and Other), Terms and Definitions, Standards/Handbooks/Manuals
Part 3: Detailed Review of the AS13100 additional requirements to the AS9100 standard: Clauses 1-8.3
 
Day 2
Part 1: Detailed Review of the additional requirements to the AS9100 standard: Clauses 8.4 – 10
Part 2: Chapter B  AS9145 Supplemental Requirements
 
Day 3
Part 1: Chapter B  AS9145 Supplemental Requirements cont.
Part 2: Core Defect Prevention Quality Tools APQP & PPAP

 


Related Courses 

AS9100 Rev D Lead Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

AS9145 APQP & PPAP Training

Advanced Product Quality Planning and Production Part Approval Process

Days: 2

 7:30 AM- 4:30 PM MST

 

Overview

Developing a new product is a complex process that requires proactive planning, strong collaboration, and reliable controls to ensure quality from concept through delivery. Without the right structure in place, organizations face costly delays, supplier quality issues, and risks that can impact performance and customer satisfaction.

Axeon’s AS9145 Advanced Product Quality Planning & Production Part Approval Process Training provides the framework needed to deliver aerospace products that meet requirements the first time. This course aligns with the AS9145 standard, which spans early concept development, design and process development, validation activities (PPAP), and post-delivery oversight. Participants will learn how these activities integrate with established aerospace quality standards, including AS9100, AS9102, AS9103, and AS9110.

Through expert guidance and practical exercises, this two-day course helps teams enhance planning discipline, strengthen supplier management, and ensure product and process readiness before full-scale production. Attendees will gain a solid understanding of project phases, documentation requirements, approval expectations, and how to apply a risk-based approach throughout the product lifecycle.

Delivered live in a virtual classroom environment, this instructor-led course includes hands-on workshops using industry tools such as SCMH checklists, real-world implementation examples, and a comprehensive case study. Whether you are overseeing production development, evaluating supplier readiness, or improving internal processes, this training equips you to reduce uncertainty, improve quality outcomes, and maintain compliance in today’s demanding aerospace environment.

AS9145 APQP & PPAP Training Key Topics  

  • APQP and PPAP terminology
  • APQP general requirements
  • APQP project management
  • APQP phases (1 to 5) requirements
  • PPAP process requirements
  • PPAP file and submission
  • PPAP disposition, submission, recording and resubmission
APQP - Three people looking at a laptop in a factory

Who Should Attend

  • Senior Managers
  • Management Representatives
  • Implementation Teams
  • Internal Auditors
  • Any others involved in the auditing or implementation of Advanced Product Quality Planning (APQP) activities including Control Plans

 

Training Objectives

  1. Understand the AS9145 standard and requirements.
  2. Experience and practice the different phases of Clause 4 in AS9145.
  3. Learn how to use SCMH checklists.
  4. Understand how to complete the Production Part Approval Process Approval Form.
  5. Apply the AS9145 standard requirements and principles to a real case study.

 

Agenda

Day 1
Part 1: Introductions
Part 2: History, Aerospace requirements for APQP/PPAP
Part 3: Activity #1 Terminology
Part 4: AS9145 Clause 4.1 – 4.2 General Requirements, Start-Up
Part 5: Workshop #1 SCMH Checklists
Part 6: AS9145 Clause 4.3, Phase I: Planning
Part 7: Workshop #2
Part 8: AS9145 Clause 4.4, Phase 2: Product Design & Development
Part 9: Workshop #3
Part 10: AS9145 Clause 4.5, Phase 3: Process Design & Development
 
Day 2
Part 1: AS9145 Clause 4.5, Phase 3: Process Design & Development
Part 2: Workshop #4
Part 3: AS9145 Clause 4.6, Phase 4: Product & Process Validation
Part 4: AS9145 Clause 4.7, Phase 5: Ongoing Production, Use, Post Delivery
Part 5: Workshop #5
Part 6: AS9145 Clause 5.1 – 5.4, PPAP
Part 7: Workshop #6
Part 8: In-Class Case Study

 


Related Courses

AS9100 Rev D Lead Auditor Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training AS9102 First Article Inspection Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training

AS9117 & AS13001 DPRV Training

Delegated Product Release Verification

Days: 3

 7:30 AM- 4:30 PM MST

 

Overview

In aerospace, product release is not just a checkpoint. It is a legal declaration of airworthiness, safety, and compliance. When authority is delegated, the responsibility is elevated. Organizations must ensure that Product Release Delegates (PRDs) have the competence, judgment, and regulatory knowledge to make release decisions with absolute confidence.

Axeon’s AS9117 & AS13001 DPRV Training delivers the structured framework required to perform Delegated Product Release Verification in today’s demanding aerospace environment. This course is built around the requirements of AS9117 and AS13001, providing a deep understanding of how delegated authority is controlled, documented, and executed to protect product integrity and flight safety.

Participants will explore how DPRV integrates within the broader aerospace quality management system landscape, including alignment with AS9100, AS9110, and AS9102, as well as industry guidance from ARP9107 and ARP9114. The result is a comprehensive view of how delegated product release fits into regulatory compliance, direct ship programs, and customer-specific flow downs.

Delivered in an interactive online format, this course equips Product Release Delegates, quality professionals, and aerospace leaders with the clarity and discipline required to safeguard airworthiness, maintain customer trust, and execute delegated authority with precision.

When release authority carries real consequences, preparation matters. This course ensures your team is ready.

Reference Materials  

This course is built directly on the requirements of AS9117 and AS13001. Participants are required to have access to these two standards for class activities and application exercises.

The course also references additional aerospace quality standards and guidance documents to provide context and integration within the broader quality management system framework, including AS9100, AS9110, AS9102, ARP9107, and ARP9114.

While these referenced documents are discussed throughout the course to enhance understanding and practical application, they are not required purchases for attendance.

DPRV - Person looking up at airplane engine

Who Should Attend

  • Product Release Delegates (PRDs)
  • Quality Managers and Supervisors
  • Quality Engineers
  • Inspection Personnel
  • Manufacturing Engineers
  • Internal Auditors
  • Individuals responsible for airworthiness and product release

 

Training Objectives

  1. Understand the role and authority of the Product Release Delegate (PRD).
  2. Interpret airworthiness regulations and aerospace standards applicable to DPRV.
  3. Apply legal, ethical, and code of conduct requirements.
  4. Recognize and mitigate human factors affecting inspection decisions.
  5. Verify key characteristics and fixed process controls.
  6. Apply proper nonconformance control and concession processing.
  7. Verify packaging, labeling, preservation, handling, and storage requirements.
  8. Apply AS9117 requirements to real-world aerospace scenarios.

 

Agenda

Day 1
Part 1: Introductions
Part 2: Role of Product Release Delegate
Part 3: Airworthiness Regulations and Standards
Part 4: Legal, Ethics, And Code of Conduct
Part 5: Human Factors
Part 6: Aerospace Products
Part 7: Flight Safety
 
Day 2
Part 1: Key Characteristics
Part 2: Fixed Production Control
Part 3: Customer Requirements and Flow Down
Part 4: Router and Certificates of Conformance
Part 5: First Article Inspection Reporting
Part 6: Dimensional Over-Inspection
 
Day 3
Part 1: Visual Inspection
Part 2: Part Marking and Serialization
Part 3: Nonconformance Control and Concession Completion / Approval
Part 4: Packaging, Labeling, Preservation, Handling, and Storage

 


Related Courses

AS9100 Rev D Lead Auditor Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training AS9102 First Article Inspection Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training

AS9102 First Article Inspection Training

Days: 1

 7:30 AM- 4:30 PM MST

 

Overview

Ensuring the quality and reliability of aerospace products starts with a thorough verification process. The AS9102 First Article Inspection (FAI) standard provides a consistent framework for documenting and verifying that products meet design specifications before full-scale production. Using this process can improve quality, reduce costs, and streamline schedules by eliminating unique organizational requirements and promoting best practices across the supply chain.

Axeon’s AS9102 FAI training provides a practical, one-day online course designed for participants at all experience levels, from beginners to seasoned professionals. Attendees will learn when and how to apply the standard, complete the required forms, and interpret documentation requirements relative to their own procedures. The course emphasizes hands-on exercises, including evaluating drawings, reviewing completed FAIRs, and completing forms from source documents to ensure a deep understanding of both process and reporting requirements.

Through guided instruction, interactive exercises, and real-world case studies, this online training equips participants with the skills needed to effectively implement FAI processes within their organization, improve product verification practices, and maintain compliance with aerospace quality standards.

Pre-Requisites  

There are no required prerequisites for this training.

This training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed or virtual copy of the AS9102 Rev C standard

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

AS9102 - Gauges on wall

Who Should Attend

  • Quality professionals at all experience levels, from beginners to seasoned practitioners
  • Quality managers and engineers responsible for product verification
  • Internal auditors evaluating FAI processes
  • Supplier quality personnel involved in completing or reviewing FAIR reports
  • Anyone responsible for implementing or maintaining AS9102-compliant procedures

 

Training Objectives

  1. Understand “When” and “How” to use the AS9102 Standard.
  2. Help you develop the knowledge and skills required to complete the required forms.
  3. Improve your understanding of the AS9102 Rev C International Standard.
  4. Learn how to interpret the requirements of the Standard and compare to your own Standard Operating Procedures (SOPs).

 

Agenda

Part 1: Introductions

  • Why do we use the FAI process?
  • When is AS9102 required? When is AS9102 not required?
  • What is required by AS9100 (an AQMS)?
  • What are practical tools for Process and Process change control in addition to/in lieu of FAI:
    • Risk Assessment
    • Production Capacity
    • Process Capability
    • Control Plan
    • Supplier Control
Part 2: The IAQG and Standards Development
Part 3: Terminology

  1. Terminology Game and Understanding the Forms lingo
Part 4: Comprehensive Review of the Standard Requirements and How to Complete the FAIR per Appendix B

  1. The Required (R), Conditionally Required (CR) and Optional (O) boxes
  2. Forms Review and Detailed Requirements for each Form and Box
Part 5: Understanding the Reporting and Objective Evidence Required in the FAIR (Firsts Article Inspection Report)

  1. In-Class evaluation of Examples of Completed Forms 1, 2 and 3
  2. The Planning, Activities and Documentation necessary to complete the AS9102 Forms
Part 6: Good Practices for Completing and Reviewing FAIRs

  1. In-Class Exercise of Evaluating Drawings and Documenting the FAI Objective Evidence
  2. In-Class Exercise Reviewing Completed FAIRs
Part 7: Completing the Forms from Source Documents.

  1. How to divine the necessary information and proper presentation of information in Forms: 1, 2 and 3
  2. Case Study: Using Drawing, Certificates of Conformance, Bill of Materials to Complete a full FAI Report
  3. Case Study: Missing information and sources of Objective Evidence for the FAI Report
Part 8: FAIR Checklist Items for Reviewing and Approving Organization and Supplier FAIR

 


Related Courses

AS9100 Rev D Lead Auditor Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training AS9145 APQP & PPAP Training AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training

AS5553 & AS6174 Counterfeit Parts Training

Days: 1 • CEU Hours: 0.8

7:30 AM – 4:30 PM

 

Overview

In today’s global aerospace and defense supply chains, counterfeit electronic parts present one of the most serious threats to safety, reliability, and compliance. A single nonconforming component can compromise mission-critical systems, increase costs, and damage customer trust. Preventing counterfeit parts is not only a quality requirement. It’s a regulatory and ethical imperative.

Developed by SAE International’s G-19 Committee, AS5553 (for manufacturers) and AS6174 (for distributors and brokers) establish standardized requirements for detecting, avoiding, and mitigating counterfeit parts throughout the supply chain. These complementary standards help organizations ensure component traceability, strengthen supplier controls, and reduce the risk of counterfeit materials entering products or assemblies.

This interactive, live-online training provides a clear understanding of both AS5553 and AS6174 and their practical implementation within an AS9100 or AS9120 Quality Management System. Through case studies, group discussions, and real-world examples, participants will learn how to identify vulnerabilities, design effective prevention processes, and audit counterfeit parts programs for compliance and continual improvement.

Led by expert instructors, you’ll explore how to:

  • Apply AS5553 and AS6174 requirements across your organization and supply chain
  • Identify and assess counterfeit part risks at all stages of procurement and production
  • Establish effective inspection, testing, and traceability processes
  • Implement supplier approval and control mechanisms
  • Report, quarantine, and mitigate suspect or confirmed counterfeit parts

Whether you are part of a manufacturing, procurement, or maintenance organization, this course equips you with the knowledge and tools to strengthen counterfeit part prevention and maintain the integrity of your products, systems, and reputation.

Topics

This training provides a detailed look at counterfeit part prevention requirements and best practices outlined in AS5553 and AS6174. Key topics include:

  • Industry challenges and risks associated with counterfeit electronic parts
  • Overview of AS5553 and AS6174 standards and their relationship to AS9100 and AS9120
  • Roles and responsibilities across an organization for counterfeit part prevention
  • Developing and maintaining counterfeit part prevention processes
  • Training personnel to recognize and respond to counterfeit part risks
  • Inspection, testing, and verification of electronic components
  • Maintaining traceability and supplier control throughout the supply chain
  • Auditing counterfeit parts prevention processes within a QMS
  • Reporting, quarantining, and responding to suspect or confirmed counterfeit parts
  • Leveraging GIDEP and other credible information sources
  • Managing obsolete parts and mitigating supply chain vulnerabilities
AS5553 - Engineer inspecting jet engine

Who Should Attend

  • End users in government or commercial sectors (e.g., DoD, NASA, UK MoD)
  • Platform and systems integrators
  • OEMs at both system and component levels
  • Contract and electronic manufacturers (CEMs)
  • Product maintenance and repair organizations
  • Material and component procurement teams
  • Any organization required by contract or seeking to strengthen its counterfeit parts prevention processes

 

Course Intent

  1. Discuss industry problems with Counterfeit Parts.
  2. Discuss industry efforts on Counterfeit Part Prevention.
  3. Discuss role of G-19, AS5553, AS6174 and other standards.
  4. Discuss the roles of various groups within an organization in preventing Counterfeit Parts from entering products.
  5. Discuss methods for auditing Counterfeit Parts Prevention (CPP) within AS 9100D/AS 9120B (ISO 9001:2015).

 

Agenda

Part 1: Course Introduction
Part 2: Counterfeit Parts History and Requirements
Part 3: C-Parts Standards and Regulations: AS5553, AS6081, CFR 48
Part 4: Terminology
Part 5: Analysis of AS5553 EEE Standard
Part 6: Review of AS6174 Material Standard

 


Related Courses 

AS9100 Rev D Lead Auditor Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

AS6500 Manufacturing Management Program Training

Days: 1

 7:30 AM- 4:30 PM MST

 

Overview

Effective manufacturing management is essential for avoiding budget overruns, project delays, and quality issues. To tackle these challenges, the SAE G-23 Manufacturing Management Committee developed AS6500, the Manufacturing Management Program, which sets the foundation for robust and efficient manufacturing practices.

AS6500 applies to every phase of the system development life cycle and is designed for use in all manufacturing programs. It emphasizes proven manufacturing management practices aimed at delivering affordable, high-quality systems that meet customer expectations.

This concise, 16-page standard incorporates insights from multiple international publications, offering valuable guidance to strengthen your current Manufacturing Management System and ensure compliance with customer requirements.

In this interactive, live-online course, you’ll explore the core requirements of AS6500 and gain practical skills to apply these principles to your role. Whether you’re looking to enhance system performance or improve manufacturing outcomes, this course will equip you with the tools and knowledge to succeed.

Topics  

  • Manufacturing Management System
  • Design Analysis for Manufacturing
  • Manufacturing: Feasibility, Risk, Readiness Levels
  • Manufacturing Planning
  • Materials Management
  • Manufacturing Workforce
  • Tooling/Test Equipment/Facilities
  • MSA
  • Process Capabilities
  • FAI
  • Supplier Quality and Management
AS6500 - Men working on giant rocket tubes

Who Should Attend

  • Senior Managers
  • Management Representatives
  • Implementation Teams
  • Internal Auditors
  • Functional Leaders: Design, Manufacturing, Engineering, Operations, Business Improvement, Purchasing, Program Management
  • Any others involved in the auditing or implementation of QMS activities

 

AS6500 Learning Objectives

  1. Review and understand the requirements, application and conformance declaration to the AS6500 standard
  2. Understand the techniques of planning, organizing, directing, coordinating, and controlling the use of people, money, materials, equipment, research and development, methods and processes, and facilities to manufacture products.
  3. Overview the MMS application of the following international publications:
    • ARP 5580 Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Application
    • AS5553 Counterfeit (EEE) Parts; Avoidance, Detection, Mitigation, and Disposition
    • AS6174 Counterfeit Material
    • AS9071 Control of Aviation Critical Safety Items
    • AS9100 Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations
    • AS9102 Aerospace First Article Inspection
    • AS9145 Aerospace Requirements for APQP/PPAP
    • EIA557 Statistical Process Control
    • STD-0016 Standard for Preparing a DMSMS Management Plan
    • DoD Deskbook: DoD Manufacturing Readiness Levels
  4. Practical workshops to enhance your understanding and successful application of this standard

 

Agenda

Part 1: Introductions
Part 2: History, Purpose, Terms & Definitions

Activity #1A & 1B:  Terminology

Part 3: Detailed Review of the AS6500 Standard Requirements

Topics & In-Class Exercises:

    • Activity #2: Management System Objectives
    • Producibility Analysis: Trade Curves
    • Design for Manufacturing & Assembly
    • MIL HDBK 727
    • Key and Critical Characteristics: Process Flow & Control Plans
    • Activity #3: Process Flow Diagram & PFMEA
    • Manufacturing Feasibility
    • MRLs
    • Production Readiness
    • Materials Management DMSMS, SD-22, Cost, Manufacturing Modeling/Simulations
    • Manufacturing System Verification
    • Lean Manufacturing
    • MSA
    • LOB
    • Lean/Six Sigma
    • VR
    • AS9103
    • Activity #4: Cp and Cpk (Process Capability)
    • FAI/FAT Supplier Management and Quality: PPAP

 


Related Courses

AS9100 Rev D Lead Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

This course is designed for managers and executives that need to understand the requirements of AS9100 and the implications for their organizations.

Learn what AS9100 registration means for your organization and how to implement it to your AS9100 Rev D QMS to gain a competitive advantage.

Many organizations are introduced to management systems because they are forced to consider ISO certification.  This overview shows how system development can happen in many different ways, but the best approach is to investigate your existing processes and system and align them with your business objectives.

As leaders, Top Managers need to be stakeholders in the achievement of the Quality Management System, accountable for its effectiveness and engage the company in achieving the intended results of the QMS- among other requirements. Every organization is different, so we customize every executive overview to incorporate top management’s particular learning and system development objectives.

Who should attend?

  • Top Managers
  • Quality professionals
  • VP/Directors of Quality
  • ISO Managers/Management Reps
  • Process owners
  • Systems professionals
  • Improvement Specialists

You will learn:

  • What does the quality system mean to you as manager, and to your team?
  • AS9100 leadership requirements per clause 5 and connecting it to other clauses in the standard
  • AS9100 and the Risk Based Approach to implementing management systems
  • The Quality principles per AS9100 and the changes to them
  • How systems work
  • Leadership requirements for developing the management system
  • Leadership requirements for running and continually improving the management system
  • The main changes to the standard including:
    • Aligning it to the High Level Structure
    • Change in terminology
    • Change in structure

This course is designed for managers and executives that need to understand the requirements of ISO 9001:2015 and the implications for their organizations.

Who Should Attend

ISO 9001:2015 project team members, members of management, senior executives, Quality Assurance Managers, internal auditors, Quality assurance professionals, and anyone who wants an introductory understanding of ISO 9001:2015.

 

Goals

To provide decision-makers with information that will help them to provide direction for their existing or planned ISO 9001:2015 quality management system.

 

Learning Outcomes

Participants will understand:

  • The requirements of ISO 9001:2015
  • The ISO process approach and its impact on the organization and the bottom line
  • Understand the implications and benefits for your organization
  • How to ensure benefits and results
  • Managements role in effective internal audits

Additional One Day Executive Overview Outcomes:

  • Identify steps necessary for your organization to successfully implement ISO 9001:2015
  • Impact on Documents and Processes
  • How ISO 9001:2015 will be interpreted by your auditor

Running Time 2 Hours

Includes Training Video and Slide Presentation

View the sample video below

Root Cause & CAPA 

This course teaches the following tools: 5W2H, Brainstorming, Ishikawa/Fishbone, Cause & Effect Tree, Five Why’s and Pareto Charts.

Learning Objectives

Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.
A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities.

Who Should Attend

Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain a basic knowledge the the most common tools for Root Cause Analysis and Corrective & Preventive Action

 Agenda

  •  Root Cause & Corrective/Preventive Action Definitions
  • Depth of Root Cause Analysis
  • Eight Step Process
  • Root Cause, Corrective/Preventive Action Tools
      • 5W2H
      • Brainstorming
      • Ishikawa or Fishbone Diagram
      • Cause & Effect Tree Analysis
      • Five Whys Method
      • Pareto Chart
  • Conclusion

ISO 9001 & IATF 16949 Auditor Training (Internal)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.6

 7:30 AM – 5:30 PM MST

 

Overview

The automotive industry relies on strong internal audit programs to maintain IATF 16949:2016 and ISO 9001:2015 certification, meet customer expectations, and improve quality system performance. Well-trained internal auditors are essential to meet these demands.

This engaging, four-day ISO 9001 & IATF 16949 Auditor Training for internal auditors prepares you to conduct internal audits with confidence and competence. Recognized by Exemplar Global, the course covers the key requirements of both ISO 9001:2015 and IATF 16949:2016 and aligns with the ISO 19011 auditing guidelines.

Led by experienced instructors, you’ll walk through each step of the internal audit process, including:

    • Understanding and interpreting ISO 9001 & IATF 16949 requirements in an audit context
    • Planning and preparing internal audit activities
    • Conducting effective audit interviews and gathering objective evidence
    • Identifying and documenting nonconformities
  • Writing audit reports and presenting findings
  • Following up on audit trails to verify corrective actions

Interactive case studies, group exercises, and audit simulations give you hands-on practice applying your knowledge to realistic audit situations. Whether you’re new to internal auditing or looking to build on your experience, this ISO 9001 and IATF 16949 auditor training course will strengthen your skills and enhance your value to your organization.

Prerequisites

There are no required prerequisites for this ISO 9001 and IATF 16949 auditor training.

This ISO 9001 & IATF 16949 auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the ISO 9001:2015 standard and IATF 16949:2016 standard.

These standards will not be provided by Axeon, but most students will be able to obtain a copy from their company.

IATF 16949 auditor training - Welder in blue welding in a dark room

Who Should Attend

  • Quality Directors
  • Quality Managers
  • Quality Engineers
  • Audit Program Managers
  • Internal Auditors
  • Quality Consultants
  • Laboratory Quality Professionals
  • Managers who are audited in QMS audits
  • Individuals who will perform audits to IATF 16949:2016 and ISO 9001:2015 standard for Quality Management Systems
  • Individuals assisting their organizations toward IATF 16949:2016 and ISO 9001:2015 registration
  • Anyone looking to improve their organization’s quality management system

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

 

ISO 9001 & IATF 16949 Auditor Training Objectives 

  1. Prepare to conduct a solo internal audit at successful course completion.
  2. Fully understand and interpret the ISO requirements.
  3. Apply the proper interpretation of the standard in actual audit situations.
  4. Understand process auditing tools leading to substantive quality system improvements.
  5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  6. Follow-up and resolve audit trails that present themselves during the audit interviews.
  7. Conduct audits that result in real improvements to the quality system.
  8. Plan and execute the entire audit process including audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

Day 1
Part 1: Introduction and Welcome
Part 2: The ISO and IATF Standards Explained
Part 3: Introduction to ISO 9001 and IATF 16949
Part 4: ISO 9001:2015 and IATF 16949:2016 Requirements
 
Day 2
Part 1: ISO 9001:2015 and IATF 16949:2016 Requirements (cont’d)
Part 2: Introduction to Turtle Diagrams and Audit Trails
Part 3: Management of Audit Programs
Part 4: Audit Planning and Preparation
 
Day 3
Part 1: Performing the Audit
Part 2: Writing Nonconformity Statements
Part 3: Closing Meeting
Part 4: Completing the Audit Report
Part 5: Corrective Action and Closeout
 
Day 4
Part 1: Linking Automotive Core Tools to IATF 16949
Part 2: Customer-Specific Requirements

 


Related Courses 

In-Person ISO 9001 Lead Auditor Training IATF 16949 & ISO 9001 Lead Auditor Training IATF 16949 Lead Auditor (TS 16949) Training Automotive Core Tools Training

 

IATF 16949:2016 Lead Auditor Training for Automotive Quality Management Systems

 Recognized by Exemplar Global

Days: 5 • CEU Hours: 4.4

 

Overview

The automotive industry demands suppliers who can consistently deliver high-quality products, meet strict customer requirements, and comply with global standards. IATF 16949:2016 builds on ISO 9001:2015 with additional requirements specific to automotive manufacturing, and organizations need skilled auditors who can verify compliance, drive performance, and support continuous improvement.

This interactive, five-day IATF 16949 Lead Auditor Training equips you with the knowledge and practical skills to audit automotive Quality Management Systems using a process-based approach. You will learn how to plan, conduct, report, and follow up on audits in alignment with ISO 19011 auditing guidelines, while gaining the confidence to lead audit teams effectively.

Throughout the course, experienced instructors will guide you through real-world scenarios that link core tools, Customer-Specific Requirements, and risk-based thinking to the audit process. Group exercises, automotive case studies, and breakout activities reinforce learning and strengthen your auditing abilities.

By the end of this program, you will be able to:

  • Interpret and apply ISO 9001 and IATF 16949 requirements
  • Evaluate a QMS for conformance and effectiveness
  • Identify and document nonconformities accurately
  • Verify corrective actions and audit closure
  • Lead first, second, and third party audits with professionalism
  • Connect auditing techniques to automotive specific requirements

Whether you are preparing for certification audits or enhancing internal audit capabilities, this course provides the essential skills needed to support compliance and improve quality throughout the automotive supply chain.

Prerequisites

We recommend that students have an understanding of both ISO 9001 and IATF 16949 and/or work experience in applying IATF 16949.

This requirement is to help ensure the student’s success in the course and ability to utilize the material.

It is also necessary to have copies of the current IATF 16949 and ISO 9001 standards. These will not be provided.

IATF 16949 Lead Auditor Training - Person welding

Who Should Attend

  • Internal auditor candidates
  • Third-party auditor candidates
  • Quality Assurance Managers
  • IATF 16949 implementation team members
  • IATF 16949 transition team members
  • Management Representatives
  • Professionals seeking competency in IATF 16949
  • Individuals involved in first-, second-, or third-party auditing

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

 

IATF 16959 Lead Auditor Training Objectives 

  1. Understand the application of quality management principles in the context of ISO 9001 and IATF 16949.
  2. Relate the quality management system to the organizational products, services, activities and operational processes.
  3. Relate organization’s context and interested party needs and expectations to the planning and implementation of an organization’s quality management system.
  4. Understand the application of the principles, procedures and techniques of auditing.
  5. Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
  6. Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
  7. Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
  8. Establish, plan and task the activities of an audit team.
  9. Communicate effectively with the auditee and audit client.
  10. Organize and direct audit team members.
  11. Prevent and resolve conflict with the auditee and/or within the audit team.
  12. Prepare and complete the audit report.
  13. Understand the purpose and applicable uses of the core tools.
  14. Link the core tools to IATF requirements.
  15. Explain the importance of Customer-Specific Requirements.

 

Agenda

Day 1
Part 1: Course Introduction & Welcome
Part 2: ISO and IATF Standards Explained
Part 3: Introduction to ISO 9001 and IATF 16949
Part 4: ISO 9001:2015 and IATF 16949:2016 Requirements
Part 5: Group Exercise: Context of the Organization
Part 6: Group Exercise: Interested Parties
Part 7: Group Exercise: Audit Scenarios
 
Day 2
Part 1: ISO 9001:2015 and IATF 16949:2016 Requirements
Part 2: Group Exercises: Audit Scenarios
Part 3: Independent QMS Written Exercise
Part 4: Introduction to Turtle Diagrams and Audit Trails
Part 5: Management of Audit Programs
Part 6: Audit Planning and Preparation
Part 7: Breakout Exercise 1: Writing an Objective and Scope Statement
Part 8: Breakout Exercise 2: Documentation Review
Part 9: Breakout Exercise 3: Creating an Audit Plan
 
Day 3
Part 1: Performing the Audit
Part 2: Breakout Exercise 4: Performing an Audit
Part 3: Conducting a Process Approach Audit
Part 4: Conducting an Audit of Risk Planning (6.1)
Part 5: Writing Nonconformity Statements
Part 6: Breakout Exercise 5: Writing Nonconformity Statements
Part 7: Closing Meeting
Part 8: Completing the Audit Report
Part 9: Corrective Action and Closeout
 
Day 4
Part 1: Linking Automotive Core Tools to IATF 16949
Part 2: Customer-Specific Requirements
Part 3: Management Systems Auditing Written Exercise
Part 4: CSR/Core Tools Examination
 
Day 5
Part 1: Leading Audit Teams
Part 2: Management System Certification Scheme and Auditor Qualifications
Part 3: Leading Management Systems Audit Teams Written Exercise
Part 4: Review of Audit Process and Audit Management Strategies
Part 5: Leading Management Systems Audit Teams Mock Audit Case Study
Part 6: Including scenarios on Risk-Based Thinking and a Process Flow/PFMEA/Control Plan Manufacturing Process Audit Scenario
Part 7: Practical Application of Audit Principles and Instructor Interviews

 

This course is offered in partnership with Omnex.


Related Courses 

IATF 16949 & ISO 9001 Internal Auditor Training In-Person ISO 9001 Lead Auditor Training Automotive Core Tools Training VDA 6.3 Process Auditor Training

 

Automotive Core Tools Training

For Process and System Auditors

Days: 2 • CTU Hours: 1.6

 7:30 AM – 4:30 PM MST

 

Overview

The automotive industry operates under some of the most demanding quality and compliance standards in the world, and organizations certified to IATF 16949:2016 are expected to demonstrate a high level of auditor competence, particularly in the application of Automotive Core Tools. These tools are essential for ensuring product quality, preventing defects, and maintaining consistent performance across the supply chain. To meet these expectations, auditors must be capable of evaluating not just whether Core Tools are in place, but whether they are being effectively implemented and sustained in real-world scenarios.

This intensive two-day course equips quality professionals, process auditors, and those preparing for VDA 6.3 or IATF 16949 audits with practical skills and knowledge to assess the correct and effective use of the Automotive Core Tools. Participants will explore audit situations commonly encountered in manufacturing environments, with a focus on APQP, PPAP (VDA 2), FMEA, MSA (VDA 5), SPC (including Ppk, Cpk, Cmk), and 8D problem solving. Through a combination of technical instruction, group work, and case-based exercises, attendees will learn to identify issues, evaluate effectiveness, and add value during internal or supplier audits.

Whether you are seeking to deepen your understanding of automotive quality methods, renew your VDA 6.3 Process Auditor qualification, or enhance your audit readiness, this course offers targeted, real-world training aligned with IATF 16949 requirements. Led by experienced instructors, it emphasizes practical application, critical thinking, and efficiency, giving you the tools to conduct high-impact audits that drive quality performance throughout your organization.

Prerequisites

There is course requires basic knowledge about Automotive Core Tools.

This course also requires qualification as IATF and/or VDA6.3 Internal Auditors. This training is aimed at qualified IATF and/or VDA 6.3 auditors seeking additional qualifications or update of qualifications.

Automotive Core Tools - A person greasing parts of an engine

Who Should Attend

  • Qualified VDA 6.3 process auditors
  • Prospective VDA 6.3 process auditors
  • Quality Managers
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Internal Auditors
  • Quality Consultants
  • Managers who are audited in QMS audits
  • Anyone looking to improve their organization’s quality management system

 

Training Objectives 

  1. Improve your understanding of the AIAG Core Tools.
  2. Improve your understanding the General Motors Supplier Quality document.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: Terminology for Core Tools
Part 3: AIAG and Core Tools Intro
Part 4: APQP Manual
Part 5: Product Design & Development
Part 6: Process Design & Development
Part 7: Feedback and Corrective Action
Part 8: Statistical Process Control
 
Day 2
Part 1: Measurement System Analysis (MSA)
Part 2: Failure Modes and Effects Analysis (AIAG & VDA)
Part 3: Production Part Approval Process (PPAP)
Part 4: Examples of Customer Specific Requirements

 


Related Courses 

ISO 9001:2015 & IATF 16949:2016 Lead Auditor Training IATF 16949 & ISO 9001 Internal Auditor Training IATF 16949 Lead Auditor (TS 16949) Training VDA 6.3 Process Auditor Training

 

Days: 4 

Learning Objectives:

Based on the ISO 9001 process approach, the basis of IATF 16949 and its specific customer requirements, this 4-day training provides the basis for VDA 6.3 process auditors. The introduction to basic audit techniques includes general requirements, methods, principles and risk analysis. This introduction enables the trainee to understand correlations and to apply and implement the correct chain of activities during the audit. These steps will guide the trainee through the general requirements of process audits and will enable the trainee to take a holistic approach to the Automotive Industry.

This training also enables the trainee to apply requirements P1 to P7 of the VDA 6.3 questionnaire through the supply chain, based on the respective interpretation and practical examples. The purpose of this training is to provide training to conduct process audits through the supply chain, the ability to identify risks and determine the potential of new suppliers. This approach is applied to the correction, stabilization and improvement of processes and is presented through exercises and examples. The aim is to ensure a robust assessment.

VDA 6.3 Training Agenda

1. Quality Systems, Application and Benefits for Process Audits (ISO 9001, IATF 16949).
2. Quality Management Methods (Approval of Initial Samples, Control Plans, Quality Plans, Risk Analysis [FMEA,…], Problem Solving Methods,…).
3. Risk Analysis with the “Turtle” Method.
4. Communication, Ethics and Code of Conduct.
5. Customer requirements and their interpretation (VDA requirements, customer-specific requirements [CSR, …]).
6. Steps of Process-oriented Auditing (from preparation to implementation).
7. Planning and Conducting the Process Audit.
8. Preparation of the Audit. Adding GD&T to a Design
9. Application of the respective questionnaires, including Potential Analysis.
10. Complement the Questionnaire through the Audit Preparation.
11. Client Requirements and their Interpretation (VDA Requirements, Client Specific Requirements [CSR,…]).
12. Evaluation and Evaluation Rules.
13. Documentation and Conclusion.

ITAR & Export Basics Training

Days: 1 • CEU Hours: 0.8

7:30 AM – 4:30 PM MST

 

Overview

A single email, file transfer, or conversation with the wrong person can trigger serious export control violations.

In today’s global and highly connected business environment, organizations often unknowingly cross regulatory boundaries when sharing technical data, working with foreign suppliers, or supporting international customers. Understanding how U.S. export control laws apply to daily operations is no longer optional. It is a critical business requirement.

U.S. export control regulations play a vital role in protecting national security by restricting the transfer of defense-related and dual-use technologies. The International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR) govern how controlled items, technical data, and services may be shared, sold, or transferred to foreign parties. For organizations involved in manufacturing, engineering, contracting, or international business, understanding these requirements is essential to maintaining compliance and avoiding severe civil and criminal penalties.

This one-day introductory course provides a practical overview of ITAR and EAR regulations, their governing authorities, and how they apply to everyday business operations. Participants will learn the key differences between ITAR- and EAR-controlled items, including the United States Munitions List (USML) and the Commerce Control List (CCL), as well as licensing concepts, registration requirements, and the role of the Directorate of Defense Trade Controls (DDTC). Real-world examples are used to illustrate how export controls apply to technical data, services, electronic communications, and global business activities.

Designed for professionals new to export compliance or those seeking a clearer understanding of their responsibilities, this course emphasizes practical application and risk awareness. By the end of this training, attendees will have a foundational understanding of ITAR and EAR requirements, the consequences of noncompliance, and the steps organizations must take to establish and maintain an effective export compliance program.

What Are ITAR and EAR?

The International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR) are U.S. government regulations that control the export, re-export, and transfer of certain items, technical data, and services. These regulations are designed to prevent sensitive defense-related and dual-use technologies from falling into the wrong hands.

ITAR applies to defense articles, services, and technical data listed on the United States Munitions List (USML) and is administered by the U.S. Department of State through the Directorate of Defense Trade Controls (DDTC). EAR applies to most other items, including many commercial and dual-use products, and is administered by the U.S. Department of Commerce through the Bureau of Industry and Security (BIS).

This course provides a foundational understanding of how ITAR and EAR apply to manufacturing, engineering, contracting, and global business operations, and what organizations must do to remain compliant.

ITAR & Export Basics - Ship piled with shipping containers

Who Should Attend

  • Business executives
  • International contracting specialists
  • Contract managers and administrators
  • Program and project managers
  • Marketing professionals
  • Engineers and other technical personnel
  • Newly appointed export compliance officers
  • Logistics personnel
  • Legal and financial advisors

 

ITAR & Export Basics Training Intent

  1. Discuss ITAR and EAR export regulations, sanctions, and penalties.
  2. Discuss the DDTC Registration process.
  3. Discuss role of 22 CFR Part 120-130.
  4. Practice export compliance and practical application.

 

Agenda

Part 1: ITAR/EAR Overview
Part 2: ITAR: International Traffic in Arms Regulations
Part 3: DDTC Registration Process
Part 4: 22 CFR Part 120-130
Part 5: USML: United States Munitions List Overview
Part 6: Part 123 – Licenses for the Export and Temporary Import of Defense Articles
Part 7: Compliance – What next?
Part 8: Compliance – Practical Application

 


Related Courses 

AS9100 Rev D Lead Auditor Training ISO 9001 Lead Auditor Training AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training Supplier Audit Training

 

ISO 14001 & ISO 45001 Systems Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 5 • CEU Hours: 4

 7:30 AM – 5:30 PM MST

 

Overview

Environmental and occupational health & safety risks affect every organization, and regulatory pressure continues to rise. To stay compliant and protect both people and the planet, companies need skilled auditors who can evaluate management systems against international standards and drive meaningful improvement.

This live-online ISO 14001 & ISO 45001 Lead Auditor Training course is recognized by Exemplar Global and provides a complete path to becoming a certified Lead Auditor for both ISO 14001:2015 and ISO 45001:2018.

Over five intensive days, you’ll develop practical auditing skills and a solid understanding of both standards, along with the tools to evaluate conformance, identify risk, and drive system improvement. Whether you’re auditing internally, working with suppliers, or supporting certification efforts, this course prepares you to lead with confidence.

This training combines environmental and occupational health & safety content in a streamlined format that is helpful for professionals at all levels. The first four days cover ISO 14001 audit training, including management system principles, audit planning, conducting interviews, writing findings, and leading audit teams. The fifth day builds on this foundation with targeted instruction on ISO 45001 and hazard identification, allowing you to complete both credentials in one course.

This program goes beyond theoretical knowledge by using case studies, exercises, and role-playing scenarios to build real-world skills. By the end of the course, you’ll be equipped to conduct value-added audits that improve system effectiveness, support regulatory compliance, and help your organization meet its environmental and safety goals.

Prerequisites

There are no required prerequisites for this training.

This ISO 14001 & ISO 45001 lead auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copies of the ISO 14001:2015 and ISO 45001:2018 standards.

These will not be provided by Axeon, but most students will be able to obtain copies from their company.

ISO 45001 Lead Auditor Training - Woman in safety gear looking at camera.

Who Should Attend

  • Environmental Managers
  • Health & Safety Managers
  • EHS Coordinators
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing or maintaining an EMS or OHSMS
  • Internal Auditors
  • EHS Consultants
  • Top Management
  • Managers who are audited in EMS or OHSMS audits
  • Anyone seeking to improve their organization’s environmental and safety performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
EM – Environmental Management Systems (ISO 14001)
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
OH – Occupational Health & Safety Management Systems (ISO 45001)

Exemplar Global TPECS Certified badge

*The AU and TL competency units offered during the course are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses. So, by adding the OH and EMS competency units to this training package, it allows you to get jointly certified to both standards.

*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 

ISO 14001 & ISO 45001 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.
  4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 14001 and ISO 45001.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: Humans and the Environment
Part 3: Test on Humans & Environment / Review
Part 4: Environmental Lingo
Part 5: Assessing Environmental Impacts
Part 6: Test on Environmental Impacts / Review
Part 7: Lunch
Part 8: Understanding ISO 14001
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Lunch
Part 5: Review Test
Part 6: AU Module – Part 1. Intro to Auditing
Part 7: Test on Part 1 / Review Test
Part 8: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Lunch
Part 6: Complete Audit Role Play Exercise 1
Part 7: Part 4. Completing the Audit
Part 8: Test on Part 4 / Review Test
Part 9: Exercise: Writing Nonconformity Statements
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Lunch
Part 4: Exercise: Conducting a Closing Meeting
Part 5: Writing the Audit Report
Part 6: Test on TL Unit / Review and Retake
Part 7: Class Wrap-Up
 
Day 5
Part 1: ISO 45001 Course Introduction
Part 2: Hazard Identification
Part 3: Understanding ISO 45001 (Part 1)
Part 4: Lunch
Part 5: Understanding ISO 45001 (Part 2)
Part 6: Test on Standard
Part 7: Review Test & Submit Corrections
Part 8: Class Wrap-Up

 


Related Courses 

ISO 14001 Lead Auditor Training ISO 45001 Lead Auditor Training ISO 14001 Internal Auditor Training ISO 45001 Internal Auditor Training

 

ISO 45001 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

Occupational health & safety risks affect every organization, and regulatory pressure continues to rise. Organizations need qualified professionals who can lead audits that improve workplace safety and ensure compliance. This live-online ISO 45001 lead auditor training course prepares you to assess occupational health and safety management systems with confidence and competence.

In just four days, you’ll learn how to interpret ISO 45001:2018 requirements and apply them throughout the full audit process. You’ll plan audits, conduct interviews, identify nonconformities, write reports, and lead effective closing meetings. The course includes interactive case studies, group exercises, and audit role-play scenarios to help you build real-world skills.

This ISO 45001 lead auditor training is recognized by Exemplar Global and fulfills the education requirements for Lead Auditor certification. New and experienced auditors will find this class invaluable as they strengthen their ability to drive health and safety improvements through the audit process.

You’ll also deepen your understanding of hazard identification, risk assessment, and the role of audits in promoting safer, more resilient workplaces. For those seeking dual certification, an optional ISO 14001 module allows you to earn both credentials in just five days.

As an ISO 45001 lead auditor, you will be equipped to lead audits that make a difference for your organization and the people it serves. This class is the first step.

Prerequisites

There are no required prerequisites for this training.

This ISO 45001 lead auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copies of the ISO 45001:2018 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 45001 Lead Auditor Training - Man holding orange cones and wearing reflective orange pants

Who Should Attend

  • Health & Safety Managers
  • EHS Coordinators
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing or maintaining an OHSMS
  • Internal Auditors
  • EHS Consultants
  • Top Management
  • Managers who are audited in OHSMS audits
  • Anyone seeking to improve their organization’s environmental and safety performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
OH – Occupational Health & Safety Management Systems (ISO 45001)
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge

*The AU and TL competency units offered during the 45001 course are generic for all Exemplar Global-recognized Lead Auditor courses.  Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses.

*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 

ISO 45001 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.
  4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 45001.

 

Agenda

Day 1
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Lunch
Part 5: Review Test
Part 6: AU Module – Part 1. Intro to Auditing
Part 7: Test on Part 1 / Review Test
Part 8: Part 2. Preparing for an Audit
 
Day 2
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Lunch
Part 6: Complete Audit Role Play Exercise 1
Part 7: Part 4. Completing the Audit
Part 8: Test on Part 4 / Review Test
Part 9: Exercise: Writing Nonconformity Statements
 
Day 3
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Lunch
Part 4: Exercise: Conducting a Closing Meeting
Part 5: Writing the Audit Report
Part 6: Test on TL Unit / Review and Retake
Part 7: Class Wrap-Up
 
Day 4
Part 1: ISO 45001 Course Introduction
Part 2: Hazard Identification
Part 3: Understanding ISO 45001 (Part 1)
Part 4: Lunch
Part 5: Understanding ISO 45001 (Part 2)
Part 6: Test on Standard
Part 7: Review Test & Submit Corrections
Part 8: Class Wrap-Up

 


Related Courses 

ISO 14001 & ISO 45001 Lead Auditor Training ISO 45001 Internal Auditor Training ISO 14001 Lead Auditor Training ISO 14001 Internal Auditor Training

 

ISO 14001 Training – EMS Lead Auditor Course (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

Organizations face increasing pressure to reduce environmental impact and comply with evolving regulations. This ISO 14001 training course for lead auditors prepares you to lead effective environmental management system audits that drive compliance, reduce risk, and support sustainability goals.

In this four-day, Exemplar Global–recognized ISO 14001 training, you’ll learn how to interpret ISO 14001:2015 requirements and apply them in real-world audit situations. The course walks you through the full audit process, from planning and conducting interviews to writing findings and leading closing meetings.

You’ll participate in interactive exercises, case studies, and audit role-play scenarios to build practical skills and gain hands-on experience. Training also covers how to assess environmental risks, identify meaningful nonconformities, and use audit results to improve system performance.

Whether you’re just starting your auditing journey or advancing your current role, this ISO 14001 training gives you the knowledge and confidence to perform value-added audits that help your organization meet its environmental and regulatory commitments.

Prerequisites

There are no required prerequisites for this training.

This ISO 14001 training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copies of the ISO 14001:2015 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 14001 Training - Air pollution coming out of a smoke stack.

Who Should Attend

  • Environmental Managers
  • EHS Coordinators
  • Management Representatives
  • Audit Program Managers
  • Lead Auditor Candidates
  • Those involved in designing or maintaining an EMS
  • Internal Auditors
  • EHS Consultants
  • Top Management
  • Managers who are audited in EMS audits
  • Anyone seeking to improve their organization’s environmental and safety performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
EM – Environmental Management Systems (ISO 14001)
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

Exemplar Global TPECS Certified badge

*The AU and TL competency units offered during the ISO 14001 training are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses.

*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

 

ISO 14001 Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.
  4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 14001.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: Humans and the Environment
Part 3: Test on Humans & Environment / Review
Part 4: Environmental Lingo
Part 5: Assessing Environmental Impacts
Part 6: Test on Environmental Impacts / Review
Part 7: Lunch
Part 8: Understanding ISO 14001
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Lunch
Part 5: Review Test
Part 6: AU Module – Part 1. Intro to Auditing
Part 7: Test on Part 1 / Review Test
Part 8: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Lunch
Part 6: Complete Audit Role Play Exercise 1
Part 7: Part 4. Completing the Audit
Part 8: Test on Part 4 / Review Test
Part 9: Exercise: Writing Nonconformity Statements
 
Day 4
Part 1: TL Unit: Leading an Audit Team
Part 2: Audit Role Play Exercise 2
Part 3: Lunch
Part 4: Exercise: Conducting a Closing Meeting
Part 5: Writing the Audit Report
Part 6: Test on TL Unit / Review and Retake
Part 7: Class Wrap-Up

 


Related Courses 

ISO 14001 & ISO 45001 Lead Auditor Training ISO 45001 Lead Auditor Training ISO 14001 Internal Auditor Training ISO 45001 Internal Auditor Training

 

ISO 14001 Course – Internal Auditor (Live-Online)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

 

Overview

Effective internal audits are key to maintaining ISO 14001 certification and driving real environmental performance. This live-online ISO 14001 course provides the knowledge and skills you need to plan, perform, and report on internal audits of an Environmental Management System (EMS).

Over three engaging days, you’ll learn how to interpret ISO 14001:2015 requirements, evaluate environmental documentation, conduct interviews, and write clear, actionable audit findings. Through hands-on activities and simulated audits of a mock company, you’ll apply what you learn in real-world scenarios.

This ISO 14001 course is recognized by Exemplar Global and is ideal for EMS coordinators, internal auditors, regulatory managers, and ISO 14001 project team members. You’ll gain practical tools to improve audit checklists, refine note-taking and interview techniques, and contribute to corrective action and system improvement.

Whether you’re preparing for your first EMS audit or want to strengthen your internal audit program, this ISO 14001 course builds the confidence and credibility to support compliance and drive environmental progress.

Prerequisites

There are no required prerequisites for this training.

This ISO 14001 course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the ISO 14001:2015 standard.

This will not be provided by Axeon, but most students will be able to obtain copy from their company.

ISO 14001 Course - 3 windmills in a field

Who Should Attend

  • Environmental Managers
  • EHS Coordinators
  • ISO 14001 Auditors
  • ISO 14001 Project Managers
  • Those involved in maintaining an EMS
  • Internal Auditors
  • EHS Consultants
  • Managers who are audited in EMS audits
  • Anyone seeking to improve their organization’s environmental performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
EM – Environmental Management Systems (ISO 14001)
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge

*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Auditor courses.

*This course is delivered by Axeon in partnership with Quality Management International, Inc.

 

ISO 14001 Course Objectives 

  1. Develop the knowledge and skills required to become an Internal Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.

 

Agenda

Day 1
Part 1: Terminology and Definitions
Part 2: Background, History and Rationale for EMS
Part 3: Introduction to the ISO 14001 family of documents
Part 4: Analysis of the Contents of ISO 14001
Part 5: Audit of the Active Manufacturing Co. (Audit #1)Audit of the Active Manufacturing Co. (Audit #1)
Part 6: Environmental System Requirements
Part 7: Analyzing EMS Audit Findings
Part 8: Exemplar Global and U.S. Certification System
Part 9: EMS Auditor Qualifications
 
Day 2
Part 1: Roles and Responsibility of Auditors
Part 2: Creation of Effective Audit Checklists
Part 3: Audit of Company Documents (Audit #2)
Part 4: Auditing Tips for the EMS Internal Auditor
Part 5: Audit of Active Mfg. – Department Audit (Audit #3)
Part 6: Compiling Audit Findings
Part 7: Documentation in the Environmental Management System
 
Day 3
Part 1: Planning and Conducting Effective Audits
Part 2: Refining Interview and Note-Taking Skills
Part 3: Applicability of the Elements to Company Situations
Part 4: Audit of Active Mfg. – Dept and System Auditing (Audit #4)
Part 5: Corrective Action Initiation and Closure
Part 6: Creation of an EMS Audit Report
Part 7: Preparation and Presentation of a Closing Meeting

 


Related Courses 

ISO 14001 & ISO 45001 Lead Auditor Training ISO 14001 Lead Auditor Training ISO 45001 Lead Auditor Training ISO 45001 Internal Auditor Training

 

ISO 45001 Internal Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

 

Overview

Strong internal audits are the backbone of an effective health and safety management system. This live-online ISO 45001 internal auditor training course gives you the knowledge and hands-on experience to evaluate your organization’s Occupational Health & Safety Management System and support continuous improvement.

Over three interactive days, you’ll learn how to interpret ISO 45001:2018 requirements and apply them throughout the full internal audit cycle, from planning and conducting audits to writing findings and supporting corrective actions. You’ll participate in role plays, case studies, and simulated audits that help you practice essential skills in a real-world context.

This course is recognized by Exemplar Global and is ideal for internal auditors, safety managers, and team members responsible for maintaining ISO 45001 systems. You’ll leave with practical tools to simplify the auditing process, including techniques for hazard identification, effective interviewing, and reporting.

Whether you’re new to auditing or refining your OH&S system, this ISO 45001 internal auditor course will help you build competence, credibility, and confidence.

Prerequisites

There are no required prerequisites for this training.

This ISO 45001 internal auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copy of the ISO 45001:2018 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

ISO 45001 Internal Auditor Training - Man wearing reflective orange pants and jacket climbing a ladder

Who Should Attend

  • Health & Safety Managers
  • EHS Coordinators
  • ISO 45001 Auditors
  • ISO 45001 Project Managers
  • Those involved in designing or maintaining an OHSMS
  • Internal Auditors
  • EHS Consultants
  • Managers who are audited in OHSMS audits
  • Anyone seeking to improve their organization’s safety performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
OH – Occupational Health & Safety Management Systems (ISO 45001)
AU – Auditing Management Systems

Exemplar Global TPECS Certified badge

*The AU competency unit offered during the 45001 course is generic for all Exemplar Global-recognized Lead Auditor courses.  Once it has been completed for one Lead Auditor course, they do not have to be repeated for additional courses.

*This course is delivered by Axeon in partnership with Quality Management International, Inc.

 

ISO 45001 Internal Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.

 

Agenda

Day 1
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Lunch
Part 5: Review Test
Part 6: AU Module – Part 1. Intro to Auditing
Part 7: Test on Part 1 / Review Test
Part 8: Part 2. Preparing for an Audit
 
Day 2
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Lunch
Part 6: Complete Audit Role Play Exercise 1
Part 7: Part 4. Completing the Audit
Part 8: Test on Part 4 / Review Test
Part 9: Exercise: Writing Nonconformity Statements
 
Day 3
Part 1: ISO 45001 Course Introduction
Part 2: Hazard Identification
Part 3: Understanding ISO 45001 (Part 1)
Part 4: Lunch
Part 5: Understanding ISO 45001 (Part 2)
Part 6: Test on Standard
Part 7: Review Test & Submit Corrections
Part 8: Class Wrap-Up

 


Related Courses 

ISO 14001 & ISO 45001 Lead Auditor Training ISO 45001 Lead Auditor Training ISO 14001 Lead Auditor Training ISO 14001 Internal Auditor Training

 

ISO 14001 & ISO 45001 Systems Internal Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

Gain the knowledge and hands-on experience to conduct effective internal audits for both ISO 14001 and ISO 45001 in one comprehensive, four-day course. This live-online training is recognized by Exemplar Global and provides dual certification to help you meet your organization’s internal auditing needs for environmental and occupational health & safety management systems.

You’ll learn how to interpret ISO 14001 requirements, evaluate environmental impacts, and audit your Environmental Management System (EMS) effectively. The course also introduces ISO 45001, so you can confidently assess workplace safety systems as part of your internal audit program.

With guided instruction, role play exercises, and step-by-step auditing tools, you’ll practice real-world skills like planning audits, conducting interviews, identifying nonconformities, and writing reports. Training aligns with ISO 19011 auditing guidelines and includes competency-based assessments to ensure you’re ready for the job.

Whether you’re a project team member, compliance professional, or just getting started with ISO 14001 and ISO 45001, this course equips you to contribute to both environmental performance and occupational health & safety success.

Prerequisites

There are no required prerequisites for this training.

This ISO 14001 & ISO 45001 internal auditor training course is beneficial for both quality novices and lifetime professionals.

All students are required to bring their own printed copies of the ISO 14001:2015 and ISO 45001:2018 standards.

These will not be provided by Axeon, but most students will be able to obtain copies from their company.

ISO 14001 & ISO 14001 Auditor Training - Fields with windmills in the distance

Who Should Attend

  • Environmental Managers
  • Health & Safety Managers
  • EHS Coordinators
  • Those involved in designing or maintaining an EMS or OHSMS
  • Internal Auditors
  • EHS Consultants
  • Managers who are audited in EMS or OHSMS audits
  • Anyone seeking to improve their organization’s environmental and safety performance

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
EM – Environmental Management Systems (ISO 14001)
AU – Auditing Management Systems
OH – Occupational Health & Safety Management Systems (ISO 45001)

Exemplar Global TPECS Certified badge

*The AU competency unit offered during the course are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Internal Auditor course, they do not have to be repeated for additional courses. So, by adding the EMS and OH competency units to this training package, it allows you to get jointly certified to both standards.

*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as an internal auditor.

 

ISO 14001 & ISO 45001 Auditor Training Objectives 

  1. Develop the knowledge and skills required to become a Lead Auditor.
  2. Improve your understanding of the international standard.
  3. Conform to the auditing practices outlined in ISO 19011.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: Humans and the Environment
Part 3: Test on Humans & Environment / Review
Part 4: Environmental Lingo
Part 5: Assessing Environmental Impacts
Part 6: Test on Environmental Impacts / Review
Part 7: Lunch
Part 8: Understanding ISO 14001
 
Day 2
Part 1: Learning Game on Pre-assignment
Part 2: Exercise: Audit Case Studies
Part 3: Test on Standard
Part 4: Lunch
Part 5: Review Test
Part 6: AU Module – Part 1. Intro to Auditing
Part 7: Test on Part 1 / Review Test
Part 8: Part 2. Preparing for an Audit
 
Day 3
Part 1: Test on Part 2 / Review Test
Part 2: Part 3. Conducting the Audit
Part 3: Test on Part 3 / Review Test
Part 4: Audit Role Play Exercise 1
Part 5: Lunch
Part 6: Complete Audit Role Play Exercise 1
Part 7: Part 4. Completing the Audit
Part 8: Test on Part 4 / Review Test
Part 9: Exercise: Writing Nonconformity Statements
 
Day 4
Part 1: ISO 45001 Course Introduction
Part 2: Hazard Identification
Part 3: Understanding ISO 45001 (Part 1)
Part 4: Lunch
Part 5: Understanding ISO 45001 (Part 2)
Part 6: Test on Standard
Part 7: Review Test & Submit Corrections
Part 8: Class Wrap-Up

 


Related Courses 

ISO 14001 Lead Auditor Training ISO 45001 Lead Auditor Training ISO 14001 Internal Auditor Training ISO 45001 Internal Auditor Training

 

This course is designed for managers and executives that need to understand the requirements of ISO 14001:2016 and the implications for their organizations.

Who Should Attend

ISO 14001:2016 project team members, members of management, senior executives, EA Managers, internal auditors, Environmental professionals, and anyone who wants an introductory understanding of ISO 14001:2016.

 

Goals

To provide decision-makers with information that will help them to provide direction for their existing or planned ISO 14001:2016 environmental management system.

 

Learning Outcomes

 

Participants will understand

  • The requirements of ISO 14001:2016
  • Understand the implications and benefits for your organization
  • How to ensure benefits and results
  • Managements role in effective internal audits

 

Additional One Day Executive Overview Outcomes

  • Identify steps necessary for your organization to successfully implement ISO 14001:2016
  • Impact on Documents and Processes
  • How ISO 14001:2016 will be interpreted by your auditor

 

_______________________________________________________________________

Days: 2 • CTUs: 1.6

This Program Will Benefit

People who are looking for a course that will provide the skills necessary to successfully implement ISO 14001. Project managers who are looking for an in-depth, start to finish understanding, of how to manage a successful project. Project managers and members of an ISO 14001 implementation team who want to know the specific steps to undertake to assure a successful project. Members of ISO 14001 project teams who want to gain critical knowledge to move their organization toward cost effective. ISO Project Managers who want to use the latest project management techniques to effectively manage their project.

 

Personnel who attend this course will leave with

  • A detailed project timeline that has been customized for their organization and its unique needs
  • A complete understanding of the project management steps necessary for success
  • A list of implications for their organization
  • A communication plan for Top Managers, Managers and decision makers and employees
  • A list of barriers unique to their organization and a plan for overcoming these
  • A project task list that is customized to their organization with names assigned to each task
  • A resource plan including a project budget
  • A Gap Analysis that identifies and prioritizes the areas requiring the most work
  • The confidence necessary to proceed with a successful project

 

Use this training to Jumpstart (or re-start) your ISO 14001 Implementation Project

This course is designed for participants who need to implement ISO 14001 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:

  • Fully understand and successfully interpret the ISO 14001 requirements
  • Achieve the benefits that are inherent within the ISO 14001 requirements
  • Proceed with their project in a timely, cost effective manner
  • Understand the obligations directed or implied within the ISO 14001 requirements
  • Create a communication plan for your organization, management and executives
  • Develop a project plan including timeline and assigned responsibility for specific tasks

The agenda and course content described below has been created by Quality Management and Educational experts with the goal of making your project a success. This is a hands on course with each student walking away from the course with “deliverables” that are intended to jump start your ISO 14001 project.

This course can be customized to meet the unique implementation needs of your organization.

 

Agenda

 

Day 1

  • Background and Introduction
  • The contents of ISO 14001
  • Activity #1 Implications of the Requirements
  • Discussion of Activity #1
  • Strategies for Making the Requirements Work for Your Organization
  • Project Management
  • Gap Analysis Activity #2

 

Day 2

  • Student Activity #3 Identifying and Communicating Anticipated Benefits
  • Student Activity #4 Differences in Approach to be Communicated
  • Student Activity #5 Anticipated Involvement (Scope of Work)
  • Student Activity #6 First Steps in Initiating the Project
  • Student Activity #7 Responsibilities within the Project
  • Student Activity #8 Reporting and controlling project results
  • Student Activity #9 Identification of Business Factors
  • Student Activity #10 Driving and Restraining Forces
  • Student Activity #11 Skills Acquisition Planning
  • Student Activity #12 Anticipated Resources
  • Student Activity #13 Budget and Deadlines
  • Student Activity #14 Building a Project Plan and Timeline
  • Selecting a Certification Body
  • Project Notes

 

As a member of your ISO 14001 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers.

Statistical Process Control (SPC) Training

Days: 2 • CTU Hours: 1.6

 7:30 AM – 4:30 PM MST

 

Overview

Modern manufacturing demands processes that are stable, predictable, and capable of consistently delivering quality results. Statistical Process Control (SPC) provides the analytical foundation needed to understand process behavior, reduce variation, and make data-driven decisions. For organizations operating under standards such as ISO 9001, AS9100, ISO 13485, and IATF 16949, the ability to correctly apply SPC methods is a critical component of process control, product conformity, and continuous improvement.

This two-day course provides a comprehensive and practical introduction to SPC, with a focus on real-world application rather than theory alone. Participants learn how to select, construct, and interpret control charts, evaluate process capability, distinguish between common and special cause variation, and use data to improve manufacturing and service processes.

Designed for individuals who analyze data, monitor processes, or lead improvement projects, this course blends technical instruction with hands-on exercises and worked examples. By the end, attendees will be able to confidently apply SPC tools within their own environment to improve stability, predictability, and performance.

Topics

  • Importance of Process Control
  • Minimum Variation
  • Controlling Quality
  • Closed Loop Control System
  • Variation Sources
  • Graphical Representations
  • Process Distribution
  • List of Common Causes and Special Causes
  • Local Actions and System Actions: Process Control and Process Capability
  • Common and Special Causes
  • X-bar and R charts
  • Rules of Probability
  • Stages for Continual Improvement: Analyze the Process, Maintain (Control) the Process, Improve the Process
Statistical Process Control - Person pointing to graph with pen

Who Should Attend

  • Quality & Process Engineers
  • Process Development & Validation Personnel
  • Quality Technicians
  • Manufacturing/Operations Personnel
  • Production Supervisors
  • Process Improvement Personnel
  • SPC Supervisors
  • Supplier Quality Personnel
  • Laboratory Personnel
  • Six Sigma Professionals

 

Training Objectives 

  1. Understand the history of Statistical Process Control.
  2. Understand the components of a control chart
  3. Construct a control chart.
  4. Interpret a control chart.
  5. Understand the types of control charts and how best to use them.
  6. Utilize RCA and troubleshooting techniques for addressing process variation.

 

Agenda

Day 1
Part 1: Course Introduction & Foundations
Part 2: Reducing Variation
Part 3: Statistical Process Control: Control Charts
Part 4: Understanding Process Behavior
 
Day 2
Part 1: Control Charts for Counts
Part 2: Control Charts for Events
Part 3: Short Run Statistical Process Control
Part 4: Troubleshooting

 


Related Courses 

AS9100 Rev D Lead Auditor Training ISO 9001 Lead Auditor Training IATF 16949 Lead Auditor (TS 16949) Training ISO 13485 Lead Auditor Training

 

Days: 1.5 • CEU Hrs: 1.2

Time: Day 1: 7:30 AM- 4:30 PM MST

Day 1: 7:30 AM- 11:30 AM MST

 

This is a one-and-a-half-day course that addresses the requirements of ASME NQA-1, Subpart 2.14 for Commercial Grade Dedication. This course also addresses the EPRI guidance on Commercial Grade Dedication and is suitable for companies in the commercial nuclear industry and those companies doing business with the Department of Energy. This class is suitable for Engineering, Quality Assurance, and Procurement personnel.

Commercial Grade Dedication Training Agenda

Day 1

Part Title Length
1 Introduction 30
2 Terminology 15
    Activity #1: Terminology
NQA-1 Requirements
75
3 DOE-HDBK Clause 5 30
4 DOE-HDBK Clause 6.0 through 6.4 45
    Activity #2: Ball Valves
Lunch
Activity #2: Ball Valves Cont.
2:45
5 DOE-HDBK Clause 6.5 through 6.6 45
    Activity #3: Air Actuated Ball Valves 45
Total class hours Day 1 – 7

Day 2

Part Title Length
5      Activity #3: Air Actuated Ball Valves 60
6 DOE-HDBK Clause 7.0 and 8
Appendix A & B
45
    Activity #4: Gaskets for Piping System 60
    Activity #5: In-Class Examples of CGD 15
Total class hours Day 2 – 3

Class is subject to minimum participation requirements.

NQA-1 Lead Auditor Training

Days: 4

 7:30 AM- 5:30 PM MST

 

Overview

The nuclear industry demands uncompromising quality and safety standards. That’s why understanding and applying the NQA-1 standard is essential for professionals responsible for ensuring compliance in nuclear environments. Axeon’s NQA-1 Lead Auditor training course is designed to provide you with the tools and expertise needed to interpret and implement this critical standard effectively.

Through this course, you’ll gain a deep understanding of NQA-1’s structure and requirements, including:

  • Developing robust Quality Assurance Programs (Part I).
  • Managing and auditing work activities under quality assurance guidelines (Part II).
  • Applying practical strategies for implementation and compliance (Part III).
  • Aligning NQA-1 with other industry standards (Part IV).

This interactive, live-online training emphasizes hands-on learning, with case studies and real-world scenarios to help you apply NQA-1 principles in your organization. Whether you’re new to quality assurance in the nuclear sector or a seasoned professional seeking to enhance your expertise, this course equips you to:

  • Strengthen your organization’s compliance efforts.
  • Lead audits with confidence and precision.
  • Drive improvements in quality, safety, and operational efficiency.

Don’t just understand the standard—master it. Join our expert instructors for a comprehensive training about NQA-1 and gain the practical skills needed to excel in nuclear quality assurance.

NQA-1 Requirements

This course will satisfy the NQA-1 requirements for training and examination of prospective Lead Auditors.

Participation in the required number of audits, evaluation of training and experience, and certification is the responsibility of the Certifying Agency.

Axeon will provide the training and testing requirements of the standard. The employer will assure participation in the required number of audits and will be the certifying agency that certifies their employees as Lead Auditors.

NQA-1 Lead Auditor Training - Nuclear Factory

Who Should Attend

  • Those who desire to become Certified Lead Auditors per NQA-1 requirements
  • Quality Assurance professionals who need to implement and maintain a Quality Program that meets the standard’s requirements
  • Suppliers of products to the nuclear industry that need to have a compliant program
  • Management of companies who need to understand the requirements and structure of an NQA-1 Quality Program

 

NQA-1 Lead Auditor Training Objectives

  1. Summarize and apply nuclear related codes and standards
  2. Structure requirements of an NQA-1 Quality Program
  3. Apply the procedures for performing the audit process from the role of the Lead Auditor
  4. Understand auditing techniques for examining, evaluating, and reporting
  5. Work with corrective actions and closing out of audit reports
  6. Participate in exercises and case studies to put techniques into practice
  7. Complete a written examination to evaluate comprehension of and ability to apply the body of knowledge

 

Agenda

Day 1

  • Introduction and Overview
  • Codes and Standards
  • Structure of QA Programs
Day 2

  • Auditing Techniques
  • Auditing Process
Day 3

  • Auditing Process (cont.)
  • Group Exercises & Case Studies
Day 4

  • Review
  • Examination
  • Closeout & Class Evaluation

 


Related Courses

NQA-1 Commercial Grade Dedication Training ISO 9001 Lead Auditor Training ISO 14001 Lead Auditor Training ISO 45001 Lead Auditor Training

CMMC Certified Professional CCP Training

Days: 4

 8:30 AM – 4:30 PM

 

Overview

Effective cybersecurity management is essential for protecting sensitive data, maintaining regulatory compliance, and securing government contracts. To address these challenges, the Department of Defense (DoD) developed the CMMC framework, which establishes standardized cybersecurity practices for organizations handling controlled unclassified information (CUI).

CMMC applies to all contractors within the defense industrial base (DIB) and is designed to strengthen cybersecurity resilience across every level of an organization. It incorporates best practices from frameworks like NIST SP 800-171, FAR 52.204-21, and DFARS clauses, ensuring a structured approach to risk management and compliance.

This interactive, live-online CCP training provides a deep dive into CMMC requirements, equipping professionals with the skills to implement cybersecurity controls, support compliance efforts, and enhance organizational security. Whether you’re preparing for a Certified CMMC Professional (CCP) role or looking to strengthen your organization’s cybersecurity posture, this course will provide the essential knowledge and tools to help you succeed.

Benefits of Attending CCP Training

  • Deepen your understanding of the CMMC framework, including levels, domains, processes, and key practices.
  • Navigate essential compliance references like NIST SP 800-171, FAR 52.204-21, and DFARS clauses with confidence.
  • Learn the critical roles and responsibilities within the Cyber AB ecosystem.
  • Prepare for the CCP certification exam and take the next step toward becoming a CMMC assessor.
CCP Training - Computer cords

Who Should Attend

  • DoD contractor employees
  • Regulatory compliance officers
  • Cybersecurity managers and consultants
  • Professionals seeking Certified Assessor roles
  • Any individuals seeking foundational knowledge of CMMC
  • Defense-sector cybersecurity professionals from all nations

 

Prerequisites for Certification

  1. Review the CCP requirements from the Cyber AB website.
  2. Learn about the CCP Exam Requirements.
  3. Take CCP training with a CAICO Approved Training Provider (ATP). ATPs can be found through the CMMC Marketplace.
  4. Pass the CCP certification exam.
  5. Recommended background and experience for the CCP program:
    • College degree in a cyber or informational technology field or 2+ years of related experience or education or 2 years of equivalent experience (including military) in a cyber, information technology, or assessment field
    • CompTIA A+ certification or equivalent knowledge/experience
  6. DoD CUI Awareness Training DoD Mandatory Controlled Unclassified Information (CUI) Training (usalearning.gov)
  7. Favorable DoD Tier 3 Background Investigation Determination or Possess a NAC (National Agency Check) or other DoD accepted clearance.

This class is offered in partnership with ecfirst.


Related Courses

CMMC Certified Assessor (CCA) Training AS9100 Rev D Lead Auditor Training ISO 9001:2015 Lead Auditor Training Root Cause Analysis & Corrective Action Training

CMMC Certified Assessor CCA Training

Days: 4

 8:30 AM – 4:30 PM

 

Overview

Certified CMMC Assessors (CCAs) play a critical role in evaluating and verifying an organization’s compliance with the CMMC framework. This advanced CCA training provides a deep dive into the CMMC Model, equipping professionals with the specialized knowledge and technical expertise needed to lead and conduct CMMC Level 2 assessments with confidence.

Delivered in a live-online, interactive format, this engaging four-day CCA training immerses you in real-world assessment scenarios that reflect the complexities of today’s cybersecurity landscape. Through hands-on exercises, collaborative discussions, and expert-led instruction, you will:

  • Apply CMMC and NIST SP 800-171 requirements.
  • Examine assessment objectives and evidence collection to ensure accurate and consistent evaluations.
  • Develop the skills to conduct structured, high-quality CMMC assessments.

This course is designed for cybersecurity professionals seeking deep technical and administrative expertise in CMMC assessments. With an interactive approach that blends instruction, real-world application, and peer collaboration, you’ll gain the skills and confidence to excel as a CMMC Assessor.

Benefits of Attending CCA Training

  • Gain the expertise to lead organizations through CMMC compliance, ensuring they meet Department of Defense cybersecurity requirements.
  • Qualify to conduct official CMMC assessments, playing a critical role in strengthening security within the Defense Industrial Base (DIB).
  • Expand and improve your career prospects with CMMC Assessor certification, opening doors to new opportunities as an assessor, consultant, or instructor.
CCA Training - Man working on computer

Who Should Attend

  • Consultants who provide CMMC guidance
  • Professionals seeking CAICO CMMC Certified Assessor roles
  • Individuals seeking CMMC Certified Instructor roles

 

Live-Online Approach

Our training approach is designed to be interactive, practical, and engaging, ensuring a well-rounded learning experience. This approach includes:

  • Engaging Instruction: Expert-led sessions featuring visuals, real-world case studies, and practical insights for deeper understanding.
  • Collaborative Discussions: Interactive dialogues that encourage questions, idea-sharing, and peer learning.
  • Practical Application: Hands-on exercises based on real scenarios to reinforce key concepts.
  • Exam Readiness: Practice quizzes modeled after certification exams to boost confidence and success.

 

Path for Certification

  1. Hold a CMMC Certified Professional (CCP) Certification.
    • The CCP credential is a prerequisite.
  2. Obtain DoD Tier 3 Clearance.
    • Gain a Tier 3 Background Investigation determination or equivalent.
  3. Maintain Good Standing with CAICO and stay compliant with CAICO application requirements.
  4. Sign required agreements and forms.
  5. Submit initial application fees and maintain certification through annual renewal fees.
  6. Complete the CMMC Assessor Course.
  7. Pass the CCA Certification Exam.
  8. Meet Professional Experience Requirements:
    • At least 3 years of cybersecurity experience
    • At least 1 year of assessment or audit experience
    • Hold a baseline certification aligned to the Intermediate/Advanced Proficiency Level under DoD Manual 8140.3 (e.g., Security Control Assessor)

This class is offered in partnership with ecfirst.


Related Courses

CMMC Certified Professional (CCP) Training DoD CMMC Certification Training Package AS9100 Rev D Lead Auditor Training ISO 9001:2015 Lead Auditor Training

CMMC Training: DoD CMMC Certification Training Package

 8:30 AM – 4:30 PM MST

 

Overview

As cybersecurity threats continue to evolve, the Department of Defense (DoD) enforces strict compliance requirements to safeguard controlled unclassified information (CUI). The Cybersecurity Maturity Model Certification (CMMC) ensures that organizations meet these rigorous standards. Certified CMMC Professionals (CCPs) and Certified CMMC Assessors (CCAs) are key to implementing and evaluating these requirements.

This DoD CMMC training package includes both the Certified CMMC Professional (CCP) course and the Certified CMMC Assessor (CCA) course, purchased together at a bundled rate. You’ll first choose the dates that work best for your CCP course. Once you have registered for your CCP, we’ll contact you to schedule your CCA course for a date that fits your availability. Each course is delivered in its full, original format with no condensed or combined content.

By registering for this package, you will:

  • Gain the foundational knowledge of CMMC principles, practices, and compliance requirements in the CCP course.

  • Build advanced skills in conducting official CMMC assessments through the CCA course.

  • Develop hands-on expertise applying NIST SP 800-171 controls in realistic scenarios.

  • Be prepared to sit for both the CCP and CCA certification exams.

Led by experienced instructors in a live-online format, this package offers flexibility in scheduling while ensuring you receive the complete training experience for each certification. Whether your goal is to guide organizations toward CMMC compliance or to perform accredited assessments, this pathway gives you the knowledge, credentials, and confidence to succeed.

Benefits of Attending CCP & CCA CMMC Training 

  • Save Money – Lower cost than buying each course separately.
  • Flexible Scheduling – Pick your CCP dates now, schedule your CCA later.
  • Two Full Courses – Complete, unabridged CCP and CCA training.
  • Streamlined Path – Secure both courses in one purchase.
  • Dual Exam Prep – Get ready for both CCP and CCA certifications.
  • Career Boost – Qualify to implement and assess CMMC requirements.
CMMC Training - Man working on computer

Who Should Attend

  • Employees of DoD contractors
  • Regulatory compliance officers
  • Cybersecurity leadership and managers
  • Consultants who provide CMMC guidance
  • Professionals seeking CAICO CMMC Certified Assessor roles
  • Individuals seeking CMMC Certified Instructor roles
  • Anyone looking to build a foundation of knowledge and skills around CMMC

 

CMMC Training Approach

Our CMMC training approach is designed to be interactive, practical, and engaging, ensuring a well-rounded learning experience. This approach includes:

  • Engaging Instruction: Expert-led sessions featuring visuals, real-world case studies, and practical insights for deeper understanding.
  • Collaborative Discussions: Interactive dialogues that encourage questions, idea-sharing, and peer learning.
  • Practical Application: Hands-on exercises based on real scenarios to reinforce key concepts.
  • Exam Readiness: Practice quizzes modeled after certification exams to boost confidence and success.

 

Prerequisites for Certification

CCP Exam Requirements

  1. College degree in a cyber or information technical field or 2 plus years of related experience or education or 2 plus years of equivalent experience (including military) in a cyber, information technology, or assessment field.
  2. Suggested CompTIA A+ or equivalent knowledge/experience.
  3. Complete CMMC Certified Professional Class offered by a Approved Training Provider (ATP).
  4. Pass DOD CUI Awareness Training no sooner than three months prior to the exam.
  5. Each student will need to register with CMMC-AB The Cyber AB and pay the application fee. Once registered, the student will receive a CMMC Professional Number (CPN). This number is mandatory if the student is planning to pursue The Cyber AB Certification. ecfirst needs this number when uploading the training completion data. Registration is available in the CMMC-AB The Cyber AB website.
  6. Students will not be able to take the exam until the CMMC-AB releases the CCP exam to the public. The student will be responsible to purchase the exam on The Cyber AB website.

CCA Exam Requirements

  1. Learn more about the CCA Exam Requirements.
  2. Take CCA training with a Approved Training Provider (ATP).
  3. Pay exam fee, register for exam, and take and pass CCA certification exam.
  4. Have or gain a favorable DoD Suitability Determination, or Possess a NAC (National Agency Check) or other DoD accepted clearance.

Below, you will register for the Certified CMMC Professional (CCP) portion of the CMMC training bundle. Once you have purchased your seat, an Axeon representative will contact you to schedule your Certified CMMC Assessor (CCA) course.


Related Courses

CMMC Certified Professional (CCP) Training CMMC Certified Assessor (CCA) Training AS9100 Rev D Lead Auditor Training ISO 9001:2015 Lead Auditor Training

Days: 5
Day 1-4: 11am – 5pm ET
Day 5: Exam Only

Detailed Course Description

Develop your expertise and value as an ISO 17025 specialist. Review, write, and understand ISO 17025 nonconformances. Hone your skills; understand the rigors of the ISO/IEC 17025:2017 standard. Consultants will benefit from this course to help transition clients from other ISO standards to the requirements of ISO/IEC 17025.This course can also be invaluable as a refresher for long-time assessors of the ISO/IEC 17025 standard.

Learning Objectives

  • Understand all of the ISO/IEC 17025:2017 elements.
  • Cover the full range of assessment techniques and good practices.
  • Benefit from practical assessment exercises.
  • Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
  • Get practical experience of planning, running, and reporting on assessments.

 

Who Should Attend

This course is for laboratory managers, laboratory technicians and laboratory technical staff, prospective assessors and consultants, and auditors of all types who want or need to learn better audit practices and want an appreciation for the technical demands of ISO/IEC 17025.

 

This course will help you:

  • Understand all of the ISO/IEC 17025:2017 elements.
  • Cover the full range of assessment techniques and good practices.
  • Benefit from practical assessment exercises.
  • Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
  • Get practical experience of planning, running, and reporting on assessments.

 

Prerequisites

All attendees are required to bring their own copy of the ISO/IEC 17025:2017 standard to this course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T804).

Agenda

 

  1. Background of ISO 17025:2017
  2. Definitions, Terminology: ISO 9000, VIM etc.
  3. Assessment and Auditing Requirements: ISO 17011:2017, ISO 19011:2018, ISO 10012:2003
  4. Logo and Symbol Use/Opening and Closing Meetings
  5. ILAC, IAAC, APLAC Recognition and Oversight
  6. ISO 17025 Requirements/Accreditation Requirements
    1. Clause 4 Review
      1. Case Studies on Clauses 4
      2. Review Clause 4 Case Studies
      3. Evening Assignments – Clause 4
  7. Accreditation Stages
  8. Document Review Exercise – Clause 5
  9. Auditing Guidelines – ISO 19011
  10. ISO 17025 Requirements
    1. Clause 5 Review
    2. Uncertainty (NIST 1297)- includes budgets and examples
  11. Traceability and PT/ILC
  12. ISO 17025 Scope of Accreditation
  13. Opening Meeting Activities
  14. Assessing ISO 17025 Using a Checklist
    1. Includes method witnessing /role playing
  15. Uncertainty Budget Software and example
  16. Case Studies: Uncertainty/PT/ILC/Traceability/Calibration Certificates
  17. Review of Assessment Case Studies and Certificate Shortcomings
  18. Assessment report Preparation
  19. Closing Meeting Participation Exercises
  20. Review of Standards and Assessment Requirements
  21. ACLASS-specific training, report types, assessor duties and resources available
  22. Practice Exam and Review
  23. Exam
  24. Audit Checklists and Audit reports
  25. Review of Standards and Internal Auditing issues
  26. Exam

 

As a member of your ISO 17025 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers. 

________________________________________________________________

This class is being taught and certified by ANAB.

Days: 5
Day 1-4: 7:30AM – 4:30PM Local Time
Day 5: Exam Only

Detailed Course Description

Develop your expertise and value as an ISO 17025 specialist. Review, write, and understand ISO 17025 nonconformances. Hone your skills; understand the rigors of the ISO/IEC 17025:2017 standard. Consultants will benefit from this course to help transition clients from other ISO standards to the requirements of ISO/IEC 17025.This course can also be invaluable as a refresher for long-time assessors of the ISO/IEC 17025 standard.

Learning Objectives

  • Understand all of the ISO/IEC 17025:2017 elements.
  • Cover the full range of assessment techniques and good practices.
  • Benefit from practical assessment exercises.
  • Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
  • Get practical experience of planning, running, and reporting on assessments.

 

Who Should Attend

This course is for laboratory managers, laboratory technicians and laboratory technical staff, prospective assessors and consultants, and auditors of all types who want or need to learn better audit practices and want an appreciation for the technical demands of ISO/IEC 17025.

 

This course will help you:

  • Understand all of the ISO/IEC 17025:2017 elements.
  • Cover the full range of assessment techniques and good practices.
  • Benefit from practical assessment exercises.
  • Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
  • Get practical experience of planning, running, and reporting on assessments.

 

Prerequisites

All attendees are required to bring their own copy of the ISO/IEC 17025:2017 standard to this course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T804).

Agenda

 

  1. Background of ISO 17025:2017
  2. Definitions, Terminology: ISO 9000, VIM etc.
  3. Assessment and Auditing Requirements: ISO 17011:2017, ISO 19011:2018, ISO 10012:2003
  4. Logo and Symbol Use/Opening and Closing Meetings
  5. ILAC, IAAC, APLAC Recognition and Oversight
  6. ISO 17025 Requirements/Accreditation Requirements
    1. Clause 4 Review
      1. Case Studies on Clauses 4
      2. Review Clause 4 Case Studies
      3. Evening Assignments – Clause 4
  7. Accreditation Stages
  8. Document Review Exercise – Clause 5
  9. Auditing Guidelines – ISO 19011
  10. ISO 17025 Requirements
    1. Clause 5 Review
    2. Uncertainty (NIST 1297)- includes budgets and examples
  11. Traceability and PT/ILC
  12. ISO 17025 Scope of Accreditation
  13. Opening Meeting Activities
  14. Assessing ISO 17025 Using a Checklist
    1. Includes method witnessing /role playing
  15. Uncertainty Budget Software and example
  16. Case Studies: Uncertainty/PT/ILC/Traceability/Calibration Certificates
  17. Review of Assessment Case Studies and Certificate Shortcomings
  18. Assessment report Preparation
  19. Closing Meeting Participation Exercises
  20. Review of Standards and Assessment Requirements
  21. ACLASS-specific training, report types, assessor duties and resources available
  22. Practice Exam and Review
  23. Exam
  24. Audit Checklists and Audit reports
  25. Review of Standards and Internal Auditing issues
  26. Exam

 

As a member of your ISO 17025 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers. 

Days: 3 • CEU Hrs: 2.4
7:30 a.m. – 4:30 p.m. (MST)

Course Description

The ISO IEC 17025:2017 Internal Auditor training course is designed to further develop your understanding of ISO/IEC 17025 and help you understand how to plan and lead an ISO/IEC 17025 assessment. Attendees will gain an understanding of uncertainty, traceability, and PT/ILC and how they are assessed. This course will prepare you to meet technical demands of the assessor while providing practical exercises to aid comprehension.

Learning Objectives

  • Understand all the elements of ISO IEC 17025:2017.
  • Cover the full range of assessment techniques, good practices, and assessor responsibilities.
  • Benefit from practical assessment exercises.
  • Gain an understanding an assessing uncertainty, traceability, and PT/ILC.
  • Get practical experience in planning, running, and reporting on assessments.

Who should attend?

This course is for laboratory managers, laboratory technicians and laboratory technical staff, prospective assessors and consultants, and auditors of all types who want to learn better laboratory audit practices and an appreciation for the technical demands of ISO/IEC 17025.

ISO IEC 17025 Agenda

Day 1

Activity Length
1 Introduction & Benefits of ISO 17025 1:00
Topics: History, Accreditation vs Compliant, TUR/TAR/CMC, ILAC, A2LA
Activity #1: Terminology ISO 17025 :30
2 Detailed Review of ISO/IEC 17025 Requirements 3:00
Lunch :30
2 Detailed Review of ISO/IEC 17025 Requirements cont. 1:45
Activity #2: Environmental and Other Factors :30
Activity #3: Determine Distribution :45
Topics: QMS Options, Impartiality, Confidentiality, Organizational Structure, Resource Requirements, Environmental, Reference Materials, Calibrations, Metrological Traceability, SI Units, Records, Lab Contracts, Decision Rules, Lab Verification & Validation of Methods, Sampling, Handling, Technical Records, Measurement Uncertainty

Day 2

Activity Length
2 Detailed Review of ISO/IEC 17025 Requirements cont. 2:15
Activity #4: Calibration Certificate :45
Activity #5: Determining Measurement Conformity :30
Activity #6: ISO 17025 Audit Case Studies 2:00
Topics: Measurement Uncertainty, Proficiency Testing (Inter-laboratory Comparisons), Reporting Results (Certificates: Calibration/Lab Tests), Calibration Frequency, Complaints, Non-Conforming Work, Management System Requirements: Options A and B, Documentation, Risks & Opportunities, Improvement, Corrective Action
Lunch :30
3 Understanding the Requirements of ISO 19011 Auditing 1:30
Topics: Principles of Auditing, Objective/Scope/Criteria, Audit Manager, Lead Auditor, Auditor, Audit Client, Determine Audit Feasibility

Day 3

Activity Length
3 Understanding the Requirements of ISO 19011 Auditing cont. 1:00
Topics: Auditing Activities, Audit Schedule, Audit Checklist, Sampling,
4 Conducting the Audit 1:30
Topics: Opening Meeting, Document Review, Interviewing Auditees, Generate Audit Findings :30
Activity #7: Prepare to be Audited – Mock Audit
Activity #8: Prepare to Perform Mock Audit
:30
Lunch :30
4 Activity #9: Perform Mock Audit
Activity #10: Debrief Audit Experience
1:30
5 Reporting NCs and Audit Reporting 1:00
Activity #11: Writing Non Conformity Statements :45

Days: 2 • CTUs: 1.6

Our ISO 17025 Training Program Will Benefit:

People who are looking for a course that will provide the skills necessary to successfully implement ISO 17025. Project managers who are looking for an in-depth, start to finish understanding, of how to manage a successful project. Project managers and members of an ISO 17025 implementation team who want to know the specific steps to undertake to assure a successful project. Members of ISO 17025 project teams who want to gain critical knowledge to move their organization toward cost effective solutions. ISO Project Managers who want to use the latest project management techniques to effectively manage their project.

 

Personnel who attend our training will leave with:

  • A detailed project timeline that has been customized for their organization and its unique needs
  • A complete understanding of the project management steps necessary for success
  • A list of implications for their organization
  • A communication plan for Top Managers, Managers and decision makers and employees
  • A list of barriers unique to their organization and a plan for overcoming these
  • A project task list that is customized to their organization with names assigned to each task
  • A resource plan including a project budget
  • A Gap Analysis that identifies and prioritizes the areas requiring the most work
  • The confidence necessary to proceed with a successful project
ISO 17025 Training

 

Use this ISO 17025 training to Jumpstart (or re-start) your Implementation Project

This course is designed for participants who need to implement ISO 17025 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:

  • Fully understand and successfully interpret the ISO 17025 requirements
  • Achieve the benefits that are inherent within the ISO 17025 requirements
  • Proceed with their project in a timely, cost effective manner
  • Understand the obligations directed or implied within the ISO 17025 requirements
  • Create a communication plan for your organization, management and executives
  • Develop a project plan including timeline and assigned responsibility for specific tasks

The agenda and course content described below has been created by Quality Management and Educational experts with the goal of making your project a success. This is a hands on ISO 17025 training that each student will walk away from with “deliverables” that are intended to jump start your ISO 17025 project.

This course can be customized to meet the unique implementation needs of your organization.

 

Agenda

 

Day One

  • Background and Introduction
  • The contents of ISO 17025
  • Activity #1 Implications of the Requirements
  • Discussion of Activity #1
  • Strategies for Making the Requirements Work for Your Organization
  • Project Management
  • Gap Analysis Activity #2

 

Day Two

  • Student Activity #3 Identifying and Communicating Anticipated Benefits
  • Student Activity #4 Differences in Approach to be Communicated
  • Student Activity #5 Anticipated Involvement (Scope of Work)
  • Student Activity #6 First Steps in Initiating the Project
  • Student Activity #7 Responsibilities within the Project
  • Student Activity #8 Reporting and controlling project results
  • Student Activity #9 Identification of Business Factors
  • Student Activity #10 Driving and Restraining Forces
  • Student Activity #11 Skills Acquisition Planning
  • Student Activity #12 Anticipated Resources
  • Student Activity #13 Budget and Deadlines
  • Student Activity #14 Building a Project Plan and Timeline
  • Selecting a Certification Body
  • Project Notes

 

As a member of your ISO 17025 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers.

Who Should Attend

Those responsible for planning and scheduling an audit program for ISO 22000, Food Safety Managers, HACCP Team members, Quality Assurance Managers, Quality professionals, or anyone desiring an understanding of ISO 22000 and how it is designed to work within your organization.

Course Objectives

  • Understand ISO 22000 requirements and the business implications of successful implementation
  • How ISO 22000 supports HACCP
  • How ISO 22000 goes beyond HACCP in providing for food safety
  • Provide critical knowledge for your staff and management
  • Gain insight into ISO 22000 and Food Safety requirements to augment/sustain your existing program
  • Implement, design and complete a successful ISO 22000 project

 

Agenda

 

Day 1

  • Background, History and Rationale for Food Safety
  • Analysis of the Contents of ISO 22000
  • Review and understand the implications of PAS 220 and GFSI
  • Identify and understand the implications of ISO 22000 and the new approach to Food Safety
  • Understand how the ISO 22000 Certification process works and the steps necessary to achieve success

 

We teach you how to use FSSC 22000 v.6 auditing to improve your organization

 Days: 4 • Price: $2095

Monday – Thursday

Learn to audit processes and management systems to improve the effectiveness of your organization. Auditing is one of the most powerful tools an organization has. Time and time again we have seen our students apply what they have learned to help top management reduce waste, prevent defects and problems, improve efficiency and create more value for their customers.

You will learn practical, hands-on audit skills and concepts that bring life to these subjects. Our students are amazed at how engaging our classes are, and at how valuable these skills are to their careers and their companies.

Each 4-day class covers:

  • Understanding the differences between the Management System, the Standard, and the Audit
  • Appreciating the value of the Management System
  • Understanding of food safety management principles
  • Interpreting the requirements of FSSC 22000
  • Understanding, evaluating and applying risk assessment principles, processes and tools
  • Interpreting the requirements of PAS 220 for basic food safety
  • Recognizing a wide variety of food safety management system components and their interrelationship with legal requirements
  • Understanding system documentation and records
  • Leadership requirements

The Workshops include:

  • Preparing food safety policies and objectives
  • Understanding the FSMS auditing process
  • Preparing an audit programme and planning an audit
  • Performing an investigation, evaluating evidence, and reporting audit results
  • Verifying and taking effective corrective action
  • Monitoring, reporting and improving system performance
  • The registration and certification process
  • Analyzing Processes to Identify Resources and Critical Controls
  • Reviewing Processes and Preparing Checklists
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting


Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment.

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Food Safety Management Systems Lead Auditor.

Even though FSSC 22000 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

Fundamentals and Applications of Geometric Dimensioning & Tolerancing (GD&T) Training

Days: 3

 7:30 AM- 4:30 PM MST

 

Overview

Geometric Dimensioning and Tolerancing (GD&T) is a powerful tool for improving communication, design clarity, and manufacturing efficiency. This three-day course provides a comprehensive, intermediate-level introduction to the ASME Y14.5 standard, giving participants the knowledge and practical skills needed to interpret, apply, and communicate GD&T effectively across design, manufacturing, and inspection processes.

The course begins with the history and principles of Geometric Dimensioning and Tolerancing, demonstrating how it enhances design intent, ensures consistency across drawings, and facilitates collaboration between engineering, purchasing, and manufacturing teams. Participants will then explore frequently used geometric controls and tolerancing practices, with a focus on positions, datum reference frames, and feature control frames. Hands-on exercises reinforce real-world applications, helping attendees understand the advantages of GD&T in mechanical engineering and manufacturing workflows.

By the end of the course, attendees will be able to read and apply Geometric Dimensioning and Tolerancing standards with confidence, make informed decisions when selecting tolerances, and improve part functionality, quality, and communication throughout the product lifecycle.

Prerequisites

Participants need to have a working understanding of technical drawings (perspectives, sections, details, etc) in order to be fully successful in this Geometric Dimensioning and Tolerancing training.

Participants also need the ASME Y14.5-2018 Dimensioning and Tolerancing standard. This will not be supplied by Axeon.

Geometric Dimensioning and Tolerancing - Person marking on technical drawings

Who Should Attend

  • Anyone who designs, drafts, engineers, purchases, manufactures, estimates, or inspects parts and assemblies
  • Professionals who use the ASME Y14.5 Dimensioning and Tolerancing standard
  • Quality Managers
  • Engineering Managers
  • Design Teams
  • Management Representatives
  • Project Teams

 

Geometric Dimensioning and Tolerancing Learning Objectives

  1. Review and understand the “old” system versus GD&T including terminology and basic rules.
  2. Understand the general rules of dimensioning and drafting per the standard.
  3. Understand the different Tolerance Zones and their definitions, concepts, and comparisons to existing systems.
  4. Understand and apply the symbology and definitions of controls.
  5. Utilize and understand the Datum Reference Frames and their definition as well as their proper construction and selections.

 

Agenda

Part 1: Introduction: What is GD&T?
Part 2: Terminology & Basic Rules
Part 3: Features and Rules

    • Intro to Features and Material Conditions
    • Rule #1 of the Envelope Principle
    • Maximum Material Condition
    • Least Material Condition
    • The Feature Control Frame
Part 4: Datums Control

    • Intro to Datums
    • Datum Reference Frame
    • Primary Datum Controls
    • Datum Targets
    • Intro to MMB and LBM
Part 5: Adding it to a Design

    • SLOF for Drawings-Size, Location, Orientation and Form
    • Choosing Datums
    • Virtual Conditions Calculations
Part 6: Form Tolerances

    • Straightness-Surface
    • Straightness-Derived Median Line
    • Flatness-Surface
    • Flatness-Derived Median Plane
    • Circularity
    • Cylindricity
Part 7: Orientation Tolerances

    • Parallelism-Surface
    • Parallelism-Axis
    • Perpendicularity-Surface
    • Perpendicularity-Axis
    • Angularity-Surface and Axis
Part 8: Profile Tolerances

    • Profile of a Surface-Basics
    • Profile In-Depth-Modifiers
    • Profile of a Line
Part 9: Location Tolerances

    • True Position
    • Functional Position Gauging
    • Concentricity
    • Symmetry
Part 10: Runout Tolerances

    • Runout/Circular Runout
    • Total Runout

 


Related Courses 

AS9100 Rev D Lead Auditor Training ISO 9001 Lead Auditor Training IATF 16949 Lead Auditor (TS 16949) Training Statistical Process Control (SPC) Training

 

How To Perform Remote Audits

Days: 0.5 • CEU Hrs: 0.4

Time: 7:30 AM- 11:30 AM MST

Description

The emergence of COVID-19 and its related worldwide travel restrictions, combined with the need to conduct quality, supplier, and/or regulatory audits, required organizations to find alternatives to the traditional face-to-face audit that can be implemented now.

Overview: 
This is a practical, how-to course that is not bogged down in academic discussions. It focuses on applying ISO guidelines for remote auditing, along with techniques for conducting audits using computer-based and telecommunication tools.
An excellent add-on to an internal- or lead-auditor training course!

Objectives
• Understand the differences between in-person and remote auditing.
• Help you identify risks and opportunities posed by remote auditing.
• Learn tips and methods for effectively performing a remote audit.

Who Should Attend?
• quality managers
• internal auditors
• audit program managers
• quality consultants
• lead auditors

Prerequisites
This training does not include full internal- or lead- auditor training. (That would be a prerequisite for this class for the Standard to be audited.)

Agenda:

1. Feasibility of Remote Auditing
2. Tips for Remote Auditing
3. Confidentiality, Security & Data Protection
4. Risk Assessment for Remote Auditing
5. Planning a Remote Audit
6. Conducting a Remote Audit
7. Limitations of Remote Auditing

Nadcap Training

Days: 1 • CEU Hours: 0.8

7:30 AM – 4:30 PM MST

 

Overview

Nadcap accreditation is a critical requirement for organizations performing special processes in the aerospace and defense supply chain. For many companies, the challenge is not understanding what Nadcap is, but knowing how to prepare, what auditors expect, and how to navigate the accreditation process successfully. Without a clear understanding of the Nadcap system, organizations often struggle with audit findings, corrective action responses, and ongoing compliance.

This basic, one-day Nadcap training course introduces participants to the Nadcap program and provides a practical overview of what it takes to prepare for and maintain Nadcap accreditation. Attendees will learn how the Nadcap system operates, what auditors are looking for during onsite assessments, and how to work effectively within the Nadcap framework. The course also addresses internal audits, self-audits, corrective action responses, and common challenges organizations face during the accreditation process.

Designed for both newcomers and experienced professionals, this training emphasizes clarity, preparation, and practical application. By the end of the course, participants will have a solid understanding of Nadcap requirements and the confidence to support accreditation activities before, during, and after a Nadcap audit.

What is Nadcap?

The National Aerospace and Defense Contractors Accreditation Program (Nadcap) is an industry-managed accreditation program administered by the Performance Review Institute (PRI). It is used to standardize and improve quality across aerospace and defense special processes such as heat treating, nondestructive testing, welding, chemical processing, and laboratories.

Nadcap accreditation involves rigorous audits against defined technical criteria and requires organizations to demonstrate process control, compliance, and continual improvement. This Nadcap training course helps participants understand how Nadcap fits into the aerospace quality landscape, how accreditation decisions are made, and what organizations must do to successfully achieve and maintain approval.

Nadcap Training - People working on a plane

Who Should Attend

  • Quality directors
  • Quality managers
  • Process owners
  • Quality engineers
  • Auditors
  • Laboratory personnel
  • Production management

 

Nadcap Training Objectives

  1. Understand the basics of Nadcap, its purpose, and documentation.
  2. Prepare for Nadcap accreditation.
  3. Understand and apply Nadcap requirements.
  4. Prepare for and perform internal audits to Nadcap criteria.
  5. Prepare for the Nadcap audit
  6. Understand how to respond to Nadcap corrective actions.

 

Agenda

Part 1: Introduction to Nadcap

  • History
  • Purpose
  • Documents
  • Meetings
  • Participation
  • Requesting certification
Part 2: Preparing for Nadcap Certification

  • Documenting requirements
  • Self-audits
  • Self-audit frequency
Part 3: The Nadcap Audit Process

  • Stages of the audit
  • ITAR
Part 4: Nonconformance Report (NCR) Response Methodology and Process

  • Response Time Frame
  • Cycles explained
  • Components of the response

 


Related Courses 

AS9100 Rev D Lead Auditor Training AS5553 & AS6174 Counterfeit Parts Training AS9102 First Article Inspection Training AS9145 APQP & PPAP Training

 

Supplier Audit Training

Days: 2 • CEU Hours: 1.9

7:30 AM – 4:30 PM MST

 

Overview

Supplier performance has a direct impact on product quality, regulatory compliance, and operational risk. Effective supplier auditing is essential for organizations that rely on external providers to meet customer, regulatory, and quality management system requirements. This two-day Supplier Audit Training equips participants with the practical skills and confidence needed to plan, conduct, and report meaningful audits that add value beyond basic compliance.

This course follows the complete audit lifecycle, from audit preparation and risk-based planning through conducting interviews, evaluating evidence, facilitating opening and closing meetings, and documenting audit results. Participants learn how to apply ISO standards and customer requirements to real-world audit situations using industry-proven techniques aligned with ISO 19011 auditing guidelines. Emphasis is placed on understanding audit objectives, selecting appropriate audit types, and evaluating supplier risks, capabilities, and performance.

Designed as a highly interactive and application-focused course, this training minimizes academic theory and maximizes hands-on learning. Through activities, roleplay exercises, and case studies, attendees practice auditing techniques in simulated supplier environments, strengthening their ability to identify issues, assess effectiveness, and communicate findings clearly and professionally. By the end of the course, participants will be prepared to conduct supplier audits with confidence, consistency, and measurable impact.

What is a Supplier Audit?

A supplier audit is a structured evaluation of a supplier’s processes, systems, and controls to determine whether they can consistently meet quality, regulatory, and customer requirements. These audits are used to assess risk, verify compliance, and identify opportunities for improvement across the supply chain.

Depending on organizational needs, these audits may focus on quality management systems, manufacturing processes, product conformity, regulatory compliance, or supplier performance. Effective audits go beyond checklist verification and evaluate how well processes are implemented, controlled, and sustained over time.

This course teaches participants how to plan and conduct supplier audits that are aligned with audit objectives, supplier risk, and applicable standards, while following best practices defined in ISO 19011.

Supplier Audit - Person looking in to Steel Lava

Who Should Attend

  • Supplier Auditors and Lead Auditors
  • Quality Engineers and Quality Technicians
  • Supplier Quality Engineers (SQE)
  • Quality Managers and Quality Supervisors
  • Purchasing and Supply Chain Professionals
  • Procurement and Sourcing Managers
  • Manufacturing and Operations Personnel
  • Regulatory and Compliance Professionals
  • Individuals involved in supplier qualification, approval, or performance monitoring

 

Supplier Audit Training Objectives

  1. Improve your understanding of the Supplier Auditing requirements in relevant International Standards.
  2. Understand the need for and different types of audits.
  3. Audit Suppliers depending on the Audit Objectives, Risks and Regulations.
  4. Conform to the auditing practices defined in ISO 19011.
  5. Improve your skills and confidence as an auditor.

 

Agenda

Day 1
Part 1: Course Introduction
Part 2: Terminology & Definitions
Part 3: Supplier Auditing: Concepts and Benefits
Part 4: Types of Audits and Auditing Tools
 
Day 2
Part 1: Initial Assessment, and Monitoring Supplier Performance, Supply Chain Risk
Part 2: Miscellaneous Topics: APQP/PPAP, Supplier Performance Metrics, Supplier Continual Improvement, Source Delegations (Delegation of Verification)

 


Related Courses 

AS9100 Rev D Lead Auditor Training ISO 9001 Lead Auditor Training ISO 13485 Lead Auditor Training AS9145 APQP & PPAP Training

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

Human Factors is a term that appears in the latest versions of several ISO standards, including:

  • ISO 9001:2015 General manufacturing QMS
  • AS9100D:2016  Aerospace QMS
  • ISO 14971:2007 Risk management for medical devices
  • ISO 45001:2018 Occupational health and safety

This Human Factors online training helps you to understand human factors in the context of each standard.  You will learn how to apply the concept of human factors to your management system and address the standard requirements.  You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.

As with all of Axeon’s courses, this is a practical, how-to that is not bogged down in academic discussions.  We use case studies, practice exercises, and learning activities to keep the training activities and build competence.

Who Should Attend our Human Factors Online Training?

·     Quality managers Also:
·     Management representatives ·     Quality consultants
·     Quality engineers ·     Those involved in performing corrective actions
·     Safety managers ·     Those involved in medical device risk management
·     Top management ·     Preparation Of Checklists From Process Analysis
·     Regulatory affairs specialists

 

Prerequisites

 

None.  Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.

Course Objectives

  • Understand the requirements of human factors in the context of each standard.
  • Learn how to address human factors within your organization’s quality and/or safety management system.
  • Provide practical tools and methods for addressing human factors.

 

Agenda

 

Day 1 

Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard

Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action

Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors

Day 2

Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety

Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance

Final Test

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management

Overview 

A QMS (Quality Management System) is NOT a cost of doing business.  It’s an investment.  And top management should expect to get a financial return on that investment.  However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.

The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015.  In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.

Why Attend?

This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.

If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.

Who Should Attend?

  • Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
  • Quality Managers and/or Management Representatives
  •  Anyone considering implementing an ISO quality system

Course Objectives

  • Understand the new top management ISO requirements and how to accomplish them.
  • Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
  • Learn how to maximize the ROI from your management system.
  • Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
  • Learn the mistakes to avoid that can negatively impact your management system.
  • To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

 

Agenda

Benefits of a Quality Management System

  • Overview of Potential Benefits, including Return on Investment (ROI)
  • Why Top Management Leadership and Commitment is Important.
  • Creating an Organizational Culture that Supports Quality.

Overview of Quality Principles

  • What is Quality?  What is Quality Management?
  • Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.

How to Maximize the ROI from your QMS

  • ROI Depends on an Organization’s Level of Commitment to its QMS System.
  • Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.
  • Using the Process Approach to Manage Quality (Turtle Diagram).
  • Establishing KPIs and Determining Process Effectiveness.
  • Continuously Improving your QMS.
  • Reducing the Costs of Poor Quality (COPQ).
  • Using Your QMS to Manage Risks and Support Your Strategic Direction.

The Five Biggest Mistakes Executives Make with Quality Management

Final Test

With Axeon’s Pick 2 Training Package*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… or send four employees to the same training. You customize your training your way to fit your needs.

Pick 2 Price = $2190

Save up to $1000!

 

*Does not include 4- and 5-day lead auditor courses.

With Axeon’s Pick 3 Training Packages*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… or send four employees to the same training.  You customize your training your way to fit your needs.

Pick 3 Price = $2985
Save up to $1800

 

*Does not include 4- and 5-day lead auditor courses.

With Axeon’s Pick 4 Training Packages*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… Or send four employees to the same training. You customize your training your way to fit your needs.

Pick 4 Price = $3800
Save up to $2850

 

*Does not include 4- and 5-day lead auditor courses.