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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.

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 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.

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.

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.

AS9100 IAQG Sanctioned Aerospace Auditor Transition Training (AATT)

Online: 10-15+ hours

Instructor-led: 4 days

Languages: English (other IAQG-approved languages to be released separately)

9100:2016 AATT Online and Instructor-Led Bundle

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 9100 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 redirected to the IAQG Training Website to finalize registration.

AATT Training Sunset

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.

 

Prerequisites

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 (see “Program Overview” for details on required online coursework).
  • 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.

Program Overview

Required:

The online modules identified as required must be completed prior to attending the instructor-led training.

Optional:

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.
Required: The online modules identified as required must be completed prior to attending the instructor-led training.

Optional: 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.

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 9101:2022forms 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, that 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.

 

Requirements for Successful Completion

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

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 pass.
  • 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.

AATT IAQG Recognized Training

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

  • Evaluation Criteria
  • Bridge from eLearning
  • Pre-Audit and Stage 1
  • Audit Planning

Day 2

  • Audit Planning (continued)
  • Auditing Top Management
  • Auditing Process Owners
  • Auditing Process Trails
  • Conclusions, Reporting, and Certification Recommendation

Day 3

  • Conclusions, Reporting, and Certification Recommendation (Cont.)
  • Roleplay (Forms Application based on Case Study)
  • Short Scenario Situations (9100/9101 Application)
  • Surveillance, Recertification, and Special Audits

Day 4

  • Assessments

Lead Auditor Training Course

 

5 Day Schedule: 7:30 AM – 5:30 PM MST
Audience: Beginner to Advanced

Overview

This five-day course was developed to cover all requirements of both the ISO 9001:2015 and IATF 16949:2016 standards, including the new IATF 16949 requirements for Internal and Second Party Auditors (clauses 7.2.3 and 7.2.4) regarding Core Tools and Customer-Specific Requirements. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & IATF16949:2016 Standards and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

 

Who Should Attend?

  • Quality Managers
  • Those who perform supplier audits
  • Management Representatives
  • Top Management
  • Audit Program Managers
  • Managers who are audited in QMS audits
  • Lead Auditor Candidates
  • Internal Auditors
  • Those involved in designing a QMS for their organizations
  • Those who perform third-party (ISO/IATF certification audits)
  • Quality Consultants

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.  All students are required to bring their own printed copy of ISO 9001:2015.  Most students will be able to obtain a copy from their company. 

Course Objectives

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

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard
Day 2

1

Learning Game on Pre-assignment

2

Exercise: Audit Case Studies

3

Test on Standards

4

Review Test

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit
Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings

Day 4

1

TL Unit: Leading an Audit Team

2

Audit Role Play Exercise 2

3

Exercise: Conducting a Closing Meeting

4

Writing the Audit Report

5

Test on TL Unit / Review Test

6

Conclusion & Evaluations

 

Day 5

1

Linking Automotive Core Tools to IATF 16949

2

Customer Specific Requirements

3

Management Systems Auditing Exercise

4

CSR/Core Tools Examination

 

 

 

We teach you how to use auditing to improve your organization

 

5 Day Schedule: 7:30 AM – 6:30 PM MST Mon – Thu

7:30 AM – 11:00 AM MST Fri

Audience: Beginner to Advanced

Each 5-day class covers:

  • Understanding of Quality Management Principles
  • Interpreting the Requirements Of ISO 9001
  • Interpreting the Requirements Of AS9110
  • Understanding System Documentation and Records
  • Documenting Your QMS (Including Combined and Integrated Systems)
  • Preparing Quality Policies and Objectives
  • Understanding the QMS Auditing Process
  • Preparing an Audit Program and Planning For Audit
  • Performing and Reporting Audits
  • Taking Effective Corrective Action
  • Monitoring, Reporting and Improving System Performance
  • The Registration and Certification Process

The Workshops include:

  • 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

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.

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, so whether you’re a seasoned professional or are entirely new to quality, you’ll come out of this class a better auditor.  All students are required to bring their own printed copy of the AS9110D standard. Most students will be able to obtain a copy from their company.

 

AS9110 Lead Auditor Training Course Objectives

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

5-Day AS9100 Rev D and ISO 9001:2015

Lead Auditor Training Course

 

5 Day Schedule: 7:30 AM – 6:30 PM MST Mon – Thu

7:30 AM – 11:00 AM MST Fri

Audience: Beginner to Advanced
 

This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication.

Overview

This course prepares you to perform effective Quality Management System (QMS) audits. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & AS9100D Standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

 

Who Should Attend?

·       quality managers ·       internal auditors
·       management representatives ·       quality consultants
·       audit program managers ·       top management
·       lead auditor candidates ·       those who perform supplier audits

 

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, so whether you’re a seasoned professional or are entirely new to quality, you’ll come out of this class a better auditor.  All students are required to bring their own printed copy of the AS9100D standard. Most students will be able to obtain a copy from their company.

 

AS9100 Course Objectives

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

 

Agenda

Day 1

Day 4

Activity

Activity

 

1

Course Introduction

1

Test on TL Unit / Review & Retake

2

History of Quality Management

2

Aerospace Industry Unit

3

AQMS Objectives Quiz

3

Test on AS Unit / Review & Retake

4

In-depth Review of Standard

4

AS9101 Unit

 

Lunch

5

Process-Based Auditing

5

Review of Standard (cont’d)

 

Lunch

6

Exercise: Audit Case Studies (part 1)

6

Audit Role Play Exercise 4

7

AS9101 Quiz / Review & Retake

Day 2

8

Exercise 3: Closing Meeting

1

Exercise: Audit Case Studies (part 2)

9

Class Wrap-Up

2

Learning Game on Pre-assignment

10

Test Prep

3

Test on Standard / Review & Retake

4

AU Module – Part 1. Intro to Auditing

Day 5 

 

Lunch

1

Test Preparation

5

Test on Part 1 / Review & Retake

2

Final Examination

6

Part 2. Preparing for an Audit

7

Test on Part 2 / Review & Retake

8

Part 3. Conducting the Audit

9

Test on Part 3 / Review & Retake

Day 3

1

Audit Role Play Exercise 1

2

Part 4. Completing the Audit

3

Test on Part 4 / Review & Retake

4

Exercise: Writing Audit Findings

Lunch

5

Audit Role Play Exercise 2

6

TL Unit: Leading an Audit Team

Seminar Content

The new Automotive Quality Management System requirements have been rebranded as IATF 16949:2016 (formerly ISO/TS 16949:2009). Although the ISO 9001 requirements have been removed from IATF 16949:2016 and are published as a separate ISO standard, IATF 16949 is not a stand-alone standard and must be used in conjunction with ISO 9001, so Omnex is continuing to offer courses that cover both the ISO 9001:2015 and IATF 16949:2016 requirements.
Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global QM, AU and TL Competency Units. This five-day course has been developed to satisfy the Exemplar Global QM, AU and TL Examination Profiles and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

  • Exemplar Global QM
  • Exemplar Global AU
  • Exemplar Global TL

This five-day course was developed to cover all requirements of both the ISO 9001:2015 and IATF 16949:2016 standards, including the new IATF 16949 requirements for Internal and Second Party Auditors (clauses 7.2.3 and 7.2.4) regarding Core Tools and Customer-Specific Requirements. Group exercises and case studies with examples from the automotive industry will be used to develop the required auditing skills. The auditing guidelines of ISO 19011 including the auditing process and methodologies, e. g., planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions and their application in the automotive process approach are covered. Auditing case studies from the automotive industry to develop skills for identifying nonconformities will be used. Techniques for leading audit teams will also be discussed.

Who Should Attend

This seminar is primarily designed for internal or third party auditor candidates, but can also be valuable for Quality Assurance Managers, IATF 16949:2016 Implementation and/or Transition Team Members, Management Representatives, and all others who would like to develop competency in IATF 16949:2016 and the auditing process for first, second and third party auditing.

Recommended Training and/or Experience

An understanding of both ISO 9001:2015 and IATF 16949:2016 requirements and/or work experience in applying IATF 16949:2016 is recommended.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes automotive-based auditing case studies.

Seminar Goals

  • Understand the application of quality management principles in the context of ISO 9001:2015 and IATF 16949:2016.
  • Relate the quality management system to the organizational products, services, activities and operational processes.
  • Relate organization’s context and interested party needs and expectations to the planning and implementation of an organization’s quality management system.
  • Understand the application of the principles, procedures and techniques of auditing.
  • Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
  • Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
  • Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
  • Establish, plan and task the activities of an audit team.
  • Communicate effectively with the auditee and audit client.
  • Organize and direct audit team members.
  • Prevent and resolve conflict with the auditee and/or within the audit team.
  • Prepare and complete the audit report.
  • Understand the purpose and applicable uses of the core tools
  • Link the core tools to IATF 16949:2016 requirements
  • Explain the importance of Customer-Specific Requirements

Seminar Outline

Day One

  • Introduction and Welcome
  • The ISO and IATF Standards Explained
  • Introduction to ISO 9001 and IATF 16949
  • ISO 9001:2015 and IATF 16949:2016 Requirements
    • Group Exercise: Context of the Organization
    • Group Exercise: Interested Parties
    • Group Exercise: Audit Scenarios

Day Two

  • ISO 9001:2015 and IATF 16949:2016 Requirements (cont’d)
    • Group Exercises: Audit Scenarios (cont’d)
    • Independent QMS Written Exercise
  • Introduction to Turtle Diagrams and Audit Trails
  • Management of Audit Programs
  • Audit Planning and Preparation
    • Breakout Exercise 1: Writing an Objective and Scope Statement
    • Breakout Exercise 2: Documentation Review
    • Breakout Exercise 3: Creating an Audit Plan

Day Three

  • Performing the Audit
    • Breakout Exercise 4: Performing an Audit
      • Conducting a Process Approach Audit
      • Conducting an Audit of Risk Planning (6.1)
  • Writing Nonconformity Statements
    • Breakout Exercise 5: Writing Nonconformity Statements
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout

Day Four

  • Linking Automotive Core Tools to IATF 16949
  • Customer-Specific Requirements
    • Management Systems Auditing Written Exercise

Day Five

  • Leading Audit Teams
  • Management System Certification Scheme and Auditor Qualifications
    • Leading Management Systems Audit Teams Written Exercise
  • Review of Audit Process and Audit Management Strategies
    • Leading Management Systems Audit Teams Mock Audit Case Study
      • Including scenarios on Risk-Based Thinking and a Process Flow/PFMEA/Control Plan Manufacturing Process Audit Scenario
  • Practical Application of Audit Principles and Instructor Interviews

 

Days: 5  • Price: $2195
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 17011:2004, ISO 19011:2002, ISO 10012
  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.

We teach you how to use auditing to improve your organization

5 Day Schedule: 7:30 AM – 6:30 PM MST Mon – Thu

7:30 AM – 11:00 AM MST Fri

Audience: Beginner to Advanced

Each 5-day class covers:

  • Understanding of Quality Management Principles
  • Interpreting the Requirements Of ISO 9001
  • Interpreting the Requirements Of AS9110
  • Understanding System Documentation and Records
  • Documenting Your QMS (Including Combined and Integrated Systems)
  • Preparing Quality Policies and Objectives
  • Understanding the QMS Auditing Process
  • Preparing an Audit Program and Planning For Audit
  • Performing and Reporting Audits
  • Taking Effective Corrective Action
  • Monitoring, Reporting and Improving System Performance
  • The Registration and Certification Process

The Workshops include:

  • 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

This course is certified by Probitas Authentication.  Successful completion of this course satisfies the Lead Auditor training requirement for AS9110 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.


5-Day AS9100D and ISO 9001:2015

Lead Auditor Training Course

 

5 Day Schedule: 7:30 AM – 6:30 PM MST Mon – Thu

7:30 AM – 11:00 AM MST Fri

Audience: Beginner to Advanced

This course is certified by Probitas Authentication.  Successful completion of this course satisfies the Lead Auditor training requirement for AS9100D Aerospace Auditor authentication.

Overview

This course prepares you to perform effective Quality Management System (QMS) audits.  You’ll learn how to interpret the verbiage of the ISO 9001:2015 & AS9100D Standard and apply its benefits to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training fun and active while building competence. This is the AS9100 Rev D training you’ll actually enjoy.

AS9100D Space Shuttle

Who Should Attend?

·       quality managers ·       internal auditors
·       management representatives ·       quality consultants
·       audit program managers ·       top management
·       lead auditor candidates ·       those who perform supplier audits

 

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, so whether you’re brand new or have been in quality for years, you’ll come out of this class a better auditor.  All students are required to bring their own printed copy of the AS9100D standard.  Most students will be able to obtain a copy from their company.

 

AS9100D Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Enable you to perform high-quality audits with confidence.
  • Improve your understanding of the AS9100D Aerospace Quality Standard.
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Conform to the auditing practices outlined in ISO 19011, ISO 9001 and AS9101
  • Fulfill the lead auditor training requirements of the IAQG Certified Lead Auditor program.

 

Agenda

Day 1

Day 4

Activity

Activity

 

1

Course Introduction

1

Test on TL Unit / Review & Retake

2

History of Quality Management

2

Aerospace Industry Unit

3

AQMS Objectives Quiz

3

Test on AS Unit / Review & Retake

4

In-depth Review of Standard

4

AS9101 Unit

 

Lunch

5

Process-Based Auditing

5

Review of Standard (cont’d)

 

Lunch

6

Exercise: Audit Case Studies (part 1)

6

Audit Role Play Exercise 4

7

AS9101 Quiz / Review & Retake

Day 2

8

Exercise 3: Closing Meeting

1

Exercise: Audit Case Studies (part 2)

9

Class Wrap-Up

2

Learning Game on Pre-assignment

10

Test Prep

3

Test on Standard / Review & Retake

4

AU Module – Part 1. Intro to Auditing

Day 5 

 

Lunch

1

Test Preparation

5

Test on Part 1 / Review & Retake

2

Final Examination

6

Part 2. Preparing for an Audit

7

Test on Part 2 / Review & Retake

8

Part 3. Conducting the Audit

9

Test on Part 3 / Review & Retake

Day 3

1

Audit Role Play Exercise 1

2

Part 4. Completing the Audit

3

Test on Part 4 / Review & Retake

4

Exercise: Writing Audit Findings

Lunch

5

Audit Role Play Exercise 2

6

TL Unit: Leading an Audit Team

5 Day Schedule: Mon-Thur 7:30 AM – 5:30 PM MST

Fri 7:30 AM – 4:30 PM MST

Audience: Beginner to Advanced
ISO 14001 Lead Auditor Training Exemplar Global TPECS Certified

This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard.
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 14001 and 45001.

Overview

This course prepares you to perform effective Environmental (14001) and Occupational Health & Safety (45001) Management System audits.  You’ll learn how to interpret the verbiage of both Standards and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

 

The course provides a Fast Track to getting Lead Auditor training for BOTH 14001 and 45001 in 5 days!

 

The first 4 days offers a complete Lead Auditor training course for ISO 14001.  It is divided into 3 competency units:

EM Environmental Management Systems (ISO 14001)
AU Auditing Management Systems (ISO 19011)
TL Leading Management Systems Audit Teams

Day 5 adds this additional competency unit:

OH Occupational Health & Safety Management Systems (ISO 45001)

*The AU and TL competency units offered during the 14001 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 competency unit to this training package, it allows you to get jointly certified to BOTH standards.

 

ISO 14001:2015 Lead Auditor Training Agenda

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

 

ISO 45001:2018 Standard Training Agenda

 

Day 5
1 Course Introduction
5 Hazard Identification
6 Understanding ISO 45001 (Part 1)
7 Lunch
8 Understanding ISO 45001 (Part 2)
3 Test on Standard
4 Review Test & Submit Corrections
6 Class Wrap-Up

 

____________________________________________________
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.

Days: 4 

Learning Objectives:

Based on the ISO9001 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.

AGENDA

 

1. Quality Systems, Application and Benefits for Process Audits (ISO9001, 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.

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6

Monday-Thursday  7:30 AM – 5:30 PM MST

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up
  • Registration, Accreditation, and Auditor Certification

The Workshops include:

  • 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


Axeon is an Exemplar Global Certified Training Provider.

ISO 9001 Lead Auditor Training Exemplar Global TPECS Certified
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

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.

Lead Auditor Training Course

Online-Virtual Classroom

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Lead Auditor Training Exemplar Global TPECS Certified

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

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      lead auditor candidates ·      Managers who are audited in QMS audits
·      internal auditors ·      Those involved in designing a QMS for their organizations
·      top management

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

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

LEAD AUDITOR WITH ISO 45001:2018

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 45001 Lead Auditor Training Exemplar Global TPECS Certified

This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard.
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 45001.

Overview

This course prepares you to perform effective Occupational Health & Safety (45001) Management System audits.  You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

The Lead Auditor training course for ISO 45001 is divided into 3 competency units:

OH Occupational Health & Safety Management Systems (ISO 45001)
*AU Auditing Management Systems (ISO 19011)
*TL Leading Management Systems Audit Teams

*The AU and TL competency units offered during the 14001 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.

If you add the Environmental Management Systems competency unit to this training package, it allows you to get jointly certified to BOTH ISO 14001:2015 and ISO 45001:2018 standards in only five days!

 

Agenda

 

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

____________________________________________________
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.

4 Day Schedule: Mon-Thur 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 14001 Lead Auditor Training Exemplar Global TPECS Certified

This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard.
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program for ISO 14001.

 

Overview

This course prepares you to perform effective Environmental (14001) Management System audits.  You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

 

This four-day training course offers a complete Lead Auditor training course for ISO 14001:2015.  It is divided into 3 competency units:

EM Environmental Management Systems (ISO 14001)
*AU Auditing Management Systems (ISO 19011)
*TL Leading Management Systems Audit Teams

*The AU and TL competency units offered during the 14001 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.

If you add the OH competency unit to this training package, it allows you to get jointly certified to BOTH ISO 14001:2015 and ISO 45001:2018 standards.

 

Agenda

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

____________________________________________________
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.

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6

Monday-Thursday  7:30 AM – 5:30 PM MST

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up
  • Registration, Accreditation, and Auditor Certification

The Workshops include:

  • 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


Axeon is an Exemplar Global Certified Training Provider.

ISO 9001 Lead Auditor Training TPECS Certified Exemplar Global
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

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.

Lead Auditor Training Course

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Lead Auditor Training Exemplar Global TPECS Certified

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

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      lead auditor candidates ·      Managers who are audited in QMS audits
·      internal auditors ·      Those involved in designing a QMS for their organizations
·      top management

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

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

Days: 4

Time:  7:30 AM- 5:30 PM MST

Monday- Wednesday ISO 9001:2015, AND Friday IATF 1649:2016

Audience: Beginner to Advanced

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting. This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.
This class teaches Internal Auditing for IATF 16949:2016 AND ISO 9001:2015 Quality Management System.
This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the IATF 16949:2016 AND ISO 9001:2015 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

TPECS Certified

Who Should Attend

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, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites. This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the IATF 16949:2016 AND ISO 9001:2015 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

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

Agenda

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: Terminology and Definitions

1. Industry vernacular from ISO 9000, ISO 19011, IATF 16949:2016 AND ISO 9001:2015
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 IATF 16949:2016 and ISO 9001:2015

1. Demystifying the IATF 16949:2016 AND ISO 9001:2015 standard
2. Interpreting and cross-referencing the quality standard
3. Analyzing audit findings
4. Audit exercises for the application of ISO standard to quality events
5. Exercise #3-#7: Short case studies in quality events

Part 4: Implementing IATF 16949 and ISO 9001:2015

1. Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
2. Risk-based Elements of 6.1, 7.5.1, and 8.1
3. Action Plan Elements of 6.2
4. Differences in Documentation and Other Requirements
5. Timetable for Transition of Certification to ISO 9001:2015 and IATF 16949:2016
6. Individualized Transition Road Map

Part 5: 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

Part 6: The Audit Process: Performing the Audit Process

1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews Exercise #9
3. Exercise #10 QMS event case studies

Part 7: 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

Part 8: The Audit Process: Finalizing the Audit

1. Writing the audit report
2. Opening and Closing Meetings
3. Exercise #14 Writing and audit report
4. Exercise #15 Writing Non-Conforming Reports
5. Exercise #16 Conducting a Closing Meeting

Review and Examination for Certificate

We teach you how to use auditing to improve your organization

 Days: 4 • Price: $2095

Monday-Friday

Learn to audit processes and management systems to improve the effectiveness of your organization.  Audit 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 ISO 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 for these Exemplar Global (RABQSA) knowledge competency units:
FS – Food Safety Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
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 ISO 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.
____________________________________________________
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.

Overview

This Standard provides requirements and guidelines for the establishment and execution of quality assurance programs during siting, design, construction, operation, and decommissioning of nuclear facilities. This Standard reflects industry experience and current understanding of the quality assurance requirements necessary to achieve safe, reliable, and efficient utilization of nuclear energy and management and processing of radioactive materials. The Standard focuses on the achievement of results, emphasizes the role of the individual and line management in the achievement of quality, and fosters the application of these requirements in a manner consistent with the relative importance of the item or activity.

The NQA-1 -2019 standard includes requirements and guidance and is organized in the following four parts:

  • Part I contains requirements for a Quality Assurance Program for nuclear facility applications.
  • Part II contains additional quality assurance requirements for the planning and conduct of specific work activities conducted under a Quality Assurance Program developed in accordance with Part I.
  • Part III contains guidance for implementing the requirements of Parts I and II. 
  • Part IV contains guidance for the application of NQA-1 and comparisons of NQA-1 with other quality requirements

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 NQA-1 requirements
  • Suppliers of products to the nuclear industry that need to have an NQA-1 compliant program
  • Management of companies who need to understand the requirements and structure of an NQA-1 Quality Program

What you will learn

  • Summary and applicability of nuclear related codes and standards
  • Structure requirements of an NQA-1 Quality Program
  • Procedures for performing the audit process from the role of the Lead Auditor
  • Auditing techniques for examining, evaluating, and reporting
  • Working with corrective actions and closing out of audit reports
  • Participation in exercises and case studies to put techniques into practice
  • Written examination to evaluate comprehension of and ability to apply the body of knowledge

This course will satisfy the NQA-1 requirements for training and examination of prospective Lead Auditors. Participation in required number of audits, evaluation of training and experience, and certification is the responsibility of the Certifying Agency. AXEON Inc. will provide the training and testing requirements of NQA-1. The employer will assure participation in the required number of audits and will be the certifying agency that certifies their employees as Lead Auditors.

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

 

3 Day Schedule: 7:30 AM – 4:30 PM MST

 

Audience: Beginner to Advanced
Process and Software Validation Training RTP Certified by Exemplar Global

Overview

Our process & software validation training course is ideal for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are tasked with process and/or software validation.

Who Should Attend?

  • Those responsible for planning and operating a compliant validation program.
  • Key players such as Process Engineers, Operations, Quality, and Regulatory personnel.
  • R&D, Design Engineers, and Product Formulators who translate product requirements into manufacturing requirements.

Agenda

  1. Introduction to Process Validation
  • Regulatory Perspective
    • Understand the key concepts of Process/Software validation in the Life Cycle of the medical device
    • Recognize the role process/software validation play in the safety and effectiveness of process outputs
    • Study the requirements of a Validation Protocol:(IQ) Installation Qualification, (OQ) Operational Qualification and (PQ) Performance Qualification
    • Understand the perspectives of the FDA, international regulators, and the GHTF
  • Process Validation Requirements
    • Verification vs. Validation decision
    • Regulatory Process/Software Validation guidance documentation
    • Requirements of 21 CFR cGMPs
    • Requirements of ISO 13485 and ISO 14971
    • Recommendations of GHTF SG-3
    • Approaches to validation (i.e. prospective, concurrent, and retrospective validation)
  • Elements of Process Validation Planning
    • Master Validation Plan
    • Statistical methodology Overview:  Capability Studies Cp and Cpk, Control Charts, Challenge Test, Design of Experiments, FMEA, Poka Yoke, Robust Design
    • Validation Methodology
    • Validation Method:
      1. Validation Team
      2. Validation Master Plan

Group Exercises:  Validation vs. Verification; Process Capability; Validation Master Plan;

  1. Process Validation Methodology cont.
  • Validation Protocol Development
  • Phases: DQ, IQ, OQ, PQ
  • Addressing Deviations
  • Final Report
  • Installation Qualification and Concepts
  • Operational Qualification and Concepts
  • Performance Qualification and Concepts
  • Process Validation Final Report
  • Maintaining State of Validation
  • Evaluating Changes in Validated Processes: Need for Re-validation/Partial Re-validation
  • Validation Case Studies:
    • Prepping for an IQ
    • Review an IQ

 

Group Exercises:  Validation Protocol Template; Review of Validation Protocol Case; Installation Qualification Template; Review Installation Qualification Case; Operational Qualification Template; Operational Qualification Case; Performance Qualification Template; Performance Qualification Case; Prepping for an IQ; Review an IQ

 

 

III. Software Validation

  • CDRH:  FDA Software Validation Guide
    • FDA Study of MD Recalls due to Software issues
    • Design Validation of Software
  • Principles of Software Validation
    • SRS:  Software Requirements Specification
    • Defect Prevention
    • Software Life Cycle
    • Software Validation Plan
    • Classic “V” Diagram
      1. Functional Specifications
      2. Design Specifications
      3. IQ Tests
      4. OQ Tests
      5. PQ Tests
      6. Reporting
  • Test Case: Log In Page Software Application
  • Software Validation Procedure
  • Software Validation After Change
  • Independence of Review
  • Flexibility and Responsibility
  • Software Validation Tasks
    • Testing by the Software Developer
    • Validation of Automated Process Equipment and Quality System Software
    • Define User Requirements
    • Validation of COTS software
  • Which software systems need validation?
  • Documentation required for a software validation
    • SRS
    • Software Verification Protocol
    • Software Verification and Validation Report
  • 10-Steps to Software Validation
    • User Requirements
    • Project Plan
    • Functional Specifications
    • GAP Analysis
    • Installation Protocol
    • Installation Report
    • Testing Protocol
    • Testing Report
    • System Release/Go Live
    • Validation Completed

Individual Exercise: In-Class Log In Page; Prepping for an OQ; Review OQ Case; Prepping for PQ; COTS Software Testing; V&V Traceability Matrix

We teach you how to use auditing to improve your organization

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.4
Audience: Beginner to Advanced
MDSAP Training Examplar Global RTP Certified

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply a proper interpretation of the ISO 13485 standard and MDSAP requirements to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
 

Who Should Attend

Individuals who will perform audits to regulatory requirements or Quality Management Systems, individuals assisting their organizations toward ISO 13485 registration or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
 

Prerequisites

There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.  All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
 

Course Objectives

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

ISO 9001:2015 Quality Management Systems Internal Auditor Course

 

We teach you how to use auditing to improve your organization

    Each 3-day class covers:

  • 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

    The Workshops include:

  • Process Analysis For Identifying Resources And Critical Controls
  • Evaluation Of A Quality Manual
  • Preparation Of An Audit Schedule
  • Preparation Of Checklists From Process Analysis
  • Factual Evidence
  • Audit Investigation
  • Nonconformity Statements

ISO 9001 Internal Auditor Training TPECS Certified

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
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.

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13458 Internal Auditor Training TPECS Certified

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      internal auditors ·      Managers who are audited in QMS audits
·      top management ·      Those involved in designing a QMS for their organizations

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

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

INTERNAL AUDITOR WITH ISO 45001:2018

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

Monday, Tuesday, Friday

Audience: Beginner to Advanced

Course Objectives

  • Help you develop the knowledge and skills required to become an Internal Auditor.
  • Improve your understanding of the International Standard.
  • Conform to the auditing practices outlined in ISO 19011.

 

Overview

This course prepares you to perform effective Occupational Health & Safety (45001) Management System audits.  You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings, and reporting.  Training includes easy-to-use tools to simplify the auditing process.

 

The Interal Auditor training course for ISO 45001 is divided into 2 competency units:

OH Occupational Health & Safety Management Systems (ISO 45001)
*AU Auditing Management Systems (ISO 19011)

 

*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Lead Auditor courses.  Once it has been completed for one Lead Auditor course, it does not have to be repeated for additional courses.

 

Agenda

 

Course Introduction

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

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

 

4 Day Schedule: Mon-Wed 7:30 AM – 5:30 PM MST

Friday 7:30 AM – 5:30 PM MST

Audience: Beginner to Advanced
ISO 14001 Internal Auditor Training TPECS Certified

This course is recognized by Exemplar Global as meeting the Knowledge requirements for Internal Auditor Certification.

Who Should Attend

Those responsible for planning and scheduling an internal audit program for ISO 14001 and those who must perform audits to ISO 14001, EMS representatives, Regulatory Affairs Managers, EMS professionals, ISO 14001 Project Managers, ISO 14001 Project Team Members or anyone desiring an in-depth understanding of the ISO 14001 Audit Process.

 

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard.
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program for ISO 14001 and 45001.

Overview

This course prepares you to perform effective Environmental (14001) and Occupational Health & Safety (45001) Management System audits.  You’ll learn how to interpret the verbiage of both Standards and apply it to your own organization.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, and reporting.  Training includes easy-to-use tools to simplify the auditing process.

 

The course provides a Fast Track to getting Internal Auditor training for BOTH 14001 and 45001 in 4 days!

The first 3 days offer a complete Internal Auditor training course for ISO 14001.  It is divided into 2 competency units:

EM Environmental Management Systems (ISO 14001)
AU Auditing Management Systems (ISO 19011)

 

Day 4 adds this additional competency unit:

OH Occupational Health & Safety Management Systems (ISO 45001)

 

*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Internal 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 OH competency unit to this training package, it allows you to get jointly certified to BOTH standards.

 

Agenda

 

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

 

Days: 3 • CTUs: 2.4

Day 1-3: 7:30AM–5:30PM MST

Who Should Attend

Those responsible for planning and scheduling an internal audit program for ISO 14001 and those who must perform audits to ISO 14001, EMS representatives, Regulatory Affairs Managers, EMS professionals, ISO 14001 Project Managers, ISO 14001 Project Team Members or anyone desiring an in-depth understanding of the ISO 14001 Audit Process.
TPECS Certified

This course will help your organization learn

  • How to interpret the ISO 14001 requirements
  • How to analyze EMS audit findings
  • The Exemplar Global and U.S. Certification System
  • EMS Auditor qualifications
  • The roles and responsibilities of EMS auditors
  • How to make Effective Audit Checklists
  • How to audit organization documents
  • Tips for the EMS Internal Auditor
  • To identify and report audit findings
  • Requirements for documentation in the Environmental Management System
  • How to plan and conduct effective EMS audits
  • How to refine interview and Note-Taking skills
  • Corrective action initiation and closure
  • Creation of an EMS Audit Report
  • Preparation and presentation of a closing meeting

 

Agenda

 

Day One

  • Terminology and Definitions
  • Background, History and Rationale for EMS
  • Introduction to the ISO 14001 family of documents
  • Analysis of the Contents of ISO 14001
  • Audit of the Active Manufacturing Co. (Audit #1)
  • Environmental System Requirements
  • Analyzing EMS Audit Findings
  • Exemplar Global and U.S. Certification System
  • EMS Auditor Qualifications

 

Day Two

  • Roles and Responsibility of Auditors
  • Creation of Effective Audit Checklists
  • Audit of Company Documents (Audit #2)
  • Auditing Tips for the EMS Internal Auditor
  • Audit of Active Mfg. – Department Audit (Audit #3)
  • Compiling Audit Findings
  • Documentation in the Environmental Management System

 

Day Three

  • Planning and Conducting Effective Audits
  • Refining Interview and Note-Taking Skills
  • Applicability of the Elements to Company Situations
  • Audit of Active Mfg. – Dept and System Auditing (Audit #4)
  • Corrective Action Initiation and Closure
  • Creation of an EMS Audit Report
  • Preparation and Presentation of a Closing Meeting

 

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

ISO 9001:2015 Quality Management Systems Internal Auditor Course

We teach you how to use auditing to improve your organization

 

    Each 3-day class covers:

  • 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

    The Workshops include:

  • Process Analysis For Identifying Resources And Critical Controls
  • Evaluation Of A Quality Manual
  • Preparation Of An Audit Schedule
  • Preparation Of Checklists From Process Analysis
  • Factual Evidence
  • Audit Investigation
  • Nonconformity Statements

 

Axeon is an Exemplar Global Certified Training Provider. ISO 9001 Internal Auditor Training TPECS Certified
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
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.

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Recognized by Exemplar Global

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      internal auditors ·      Managers who are audited in QMS audits
·      top management ·      Those involved in designing a QMS for their organizations

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

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

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced
IVDR Training Recognized by Exemplar Global

The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition!

Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation. 

Overview

A three-day course on the In Vitro Diagnostic Regulation 2017/746 with a focus on the requirements for Medical Device Manufacturers.

In this course, you will receive a general overview of the IVDR, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the IVDR, an IVDR gap analysis template, a General Safety and Performance Requirements (GSPR) checklist, and a Technical Documentation Checklist.

Who Should Attend

Individuals who will perform audits to IVDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward IVDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.

Objectives

  • Outline the primary changes that need to be addressed to Transition from IVDD compliance to IVDR compliance
  • Practical guidance on how to address the new IVDR requirements
  • Describe/Understand the objectives, terminology and structure of the IVDR.
  • Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier
  • Explain the impact of the new IVDR requirements on economic operators (importers, authorized representatives) including manufacturers.
  • 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.
  • Describe the increased requirements for risk management including risk benefit and state of the art
  • Plan a gap assessment to transition an organization to compliance.
  • Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist)
  • Identify the necessary step as to prepare an organization to transition to the IVDR.

Agenda

  • High level overview of the EU IVD Regulation
    1. Definitions
    2. Primary changes in the regulation and how to address them
  • Implementation timeline
  • Review of the 113 MDR Articles, the organization of the regulation and “how to find things”
  • Paths to CE Mark
  • Review of the 14 Annexes, their structure and “how to find things”
  • Lifecycle of a Medical Device and related Articles and Annex requirements
    1. Proof of Concept
    2. Design & Development
    3. Device Classification
    4. Design and Safety Requirements
    5. Risk Management
    6. Performance Evaluations
    7. Performance Studies
    8. Manufacturing requirements
      1. UDI requirements
    9. Conformity Assessments – Class A, B, C, D
    10. Technical Documentation
    11. Conformity Paths for – Class A, B, C, D
    12. Registration of Devices and Placing on the Market
    13. Post Market Surveillance and Vigilance
  • Review of Significant Articles
    1. In Depth Review and Discussion of Articles
  • Review of Significant Annexes
    1. In Depth Review and Discussion of Annexes
  • Strategy for Deployment
  • Significant Pitfalls to watch out for
  • Unknowns – Still to be determined
  • Tools and References

 

Quizzes, Tools, Workshops: Each day are ongoing quizzes to confirm your understanding of key concepts;  Review of helpful tools including:  EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14971:2019 checklist and comparison to the MDR requirements;  Further, there are workshops including:  Device Classification, Compliance Scenarios, and review of practical implementation examples.

 

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.

Days: 3 

 7:30 AM- 4:30 PM MST

Overview

This intermediate course begins as an introduction to the ASME Y14.5 standard and the history of GD&T.  Attendees, through practical applications and exercises will demonstrate the strengths and advantages of GD&T as a design tool, manufacturing, and purchasing aid, and overall communications facilitating tool.  The course then shifts to cover some of the more used geometric dimensioning controls in mechanical engineering drawings.  Basic applications of positions are explained in greater detail.

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
  • Prerequisites: A working understanding of technical drawings (perspectives, sections, details, etc) Possession of the ASME y14.5-2009 Dimensioning and Tolerancing standard is required.

Learning Objectives:

  • Review the “old” system versus GD&T including terminology and basic rules
  • General rules of dimensioning and drafting per the standard
  • Tolerance Zones- definition, concepts, comparisons to existing systems
  • GD&T symbology and definitions of controls
  • Datum Reference Frames- definition and proper construction and selections

 

AGENDA

  • Introduction: What is GD&T
  • Terminology & Basic Rules
  • Features and Rules of GD&T
    • Intro to Features and Material Conditions
    • Rule #1 of GD&T- Envelope Principle
    • Maximum Material Condition
    • Least Material Condition
    • The Feature Control Frame
  • Datums Control
    • Intro to Datums
    • Datum Reference Frame
    • Primary Datum Controls
    • Datum Targets
    • Intro to MMB and LBM
  • Adding GD&T to a Design
    • SLOF for Drawings-Size, Location, Orientation and Form
    • Choosing Datums
    • Virtual Conditions Calculations
  • Form Tolerances
    • Straightness-Surface
    • Straightness-Derived Median Line
    • Flatness-Surface
    • Flatness-Derived Median Plane
    • Circularity
    • Cylindricity
  • Orientation Tolerances
    • Parallelism-Surface
    • Parallelism-Axis
    • Perpendicularity-Surface
    • Perpendicularity-Axis
    • Angularity-Surface and Axis
  • Profile Tolerances
    • Profile of a Surface-Basics
    • Profile In-Depth-Modifiers
    • Profile of a Line
  • Location Tolerances
    • True Position
    • Functional Position Gauging
    • Concentricity
    • Symmetry
  • Runout Tolerances
    • Runout/Circular Runout
    • Total Runout

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced
EU MDR Training Recognized by Exemplar Global

Overview  

Three-day course on the Medical Device Regulation 2017/745 with a focus on the requirements for Medical Device Manufacturers.

In this course you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the MDR, an MDR gap analysis template, and a General Safety and Performance Requirements (GSPR) checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.

Who Should Attend

Individuals who will perform audits to MDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward MDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.

Objectives

  • Outline the primary changes that need to be addressed to Transition from MDD/AIMD compliance to MDR compliance
  • Practical guidance on how to address the new MDR requirements
  • Describe/Understand the objectives, terminology and structure of the MDR.
  • Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier
  • Explain the impact of the new MDR requirements on economic operators (importers, authorized representatives) including manufacturers.
  • 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.
  • Describe the increased requirements for risk management including risk benefit and state of the art
  • Plan a gap assessment to transition an organization to compliance.
  • Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist)
  • Identify the necessary step as to prepare an organization to transition to the MDR.

Agenda

  • High level overview of the EU MDR Regulation
    1. Definitions
    2. Primary changes in the regulation and how to address them
  • Implementation timeline
  • Review of the 123 MDR Articles, the organization of the regulation and “how to find things”
  • Paths to CE Mark
  • Review of the 178 Annexes, their structure and “how to find things”
  • Lifecycle of a Medical Device and related Articles and Annex requirements
    1. Proof of Concept
    2. Design & Development
    3. Device Classification
    4. Design and Safety Requirements
    5. Risk Management
    6. Clinical Evaluations
    7. Clinical Investigations
    8. Manufacturing requirements
      1. UDI requirements
    9. Conformity Assessments – Class I, IIa, IIb, III
    10. Technical Documentation
    11. Conformity Paths for – Class I, IIa, IIb, III
    12. Registration of Devices and Placing on the Market
    13. Post Market Surveillance and Vigilance
  • Review of Significant Articles
    1. In Depth Review and Discussion of Articles
  • Review of Significant Annexes
    1. In Depth Review and Discussion of Annexes
  • Strategy for Deployment
  • Significant Pitfalls to watch out for
  • Unknowns – Still to be determined
  • Tools and References

 

Quizzes, Tools, Workshops:  Each day are ongoing quizzes to confirm your understanding of key concepts;  Review of helpful Tools including:  EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14941:2012 checklist and comparison to the MDR requirements;  Further, there are Workshops including:  Device Classification, Compliance Scenarios, and review of practical implementation examples.

 

Course Certification

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.

Days: 3 

 7:30 AM- 4:30 PM MST

Overview

The AS13100 AESQ (Aerospace Engine Supplier Quality) Supplemental QMS Requirements simplifies and harmonizes: a)  the aerospace engine manufacturer requirements for its supply chain, and, b) requirements flowed-down to the engine manufacturers by regulators, customers, and industry.  Suppliers with multiple customers will learn how coordinate and apply AS13100 to minimize total requirements and improve overall product quality.

This course provides review of and insight into each of the AESQ supplemental requirements.  Workshop activities have been tailored for understanding how to apply this Standard and the additional RM (Reference Manual) requirements.  Participants will learn how to apply this Standard within their own organization and coordinate the requirements between their Customers, Regulatory Authorities, and their own Supply Chain.

 

AS13100 FMEA

 

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 PPAP

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

AS13100 Learning Objectives:

  • Understand the requirements of the AS13100 standard
  • Practical application of the AS13100 requirements
  • Identification of Standards and Handbooks reference in AS13100 and overview of these guidance materials
  • Overview and Activities/Workshops related to the Reference Manuals:
    • RM13000 Problem Solving Methods including 8D
    • RM13002 Alternate Inspection Frequency Plans
    • RM13003 Measurement Systems Analysis (MSA)
    • RM13004 Defect Prevention Quality Tools to support APQP and PPAP
    • RM13005 Quality Audit Requirements
    • RM13006 Process Control Methods
    • RM13007 Sub Tier Management
    • RM13008 Design Work
    • RM13009 AS13100 Compliance Matrix
    • RM13010 Human Factors
    • RM13011 Rework and Production Repair of NC Products
    • RM13102 First Article Inspection
    • RM13145 APQP and PPAP within Aerospace
  • Workshops to enhance understanding of Tools and RMs
  • Understanding of the Core Tools including: Design FMEA, Process Flow Diagrams, Process FMEA, Production Control Plans, Measurement Systems Analysis, and Process Capability Studies

 

Who Should Attend

  • 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

 

AGENDA

Day 1

Part 1 Introductions
Part 2 History, Purpose, Related Publications (SAE/AESQ/ISO and Other), Terms and Definitions, Standards/Handbooks/Manuals  
Activity #1:  Terminology  
Part 3 Detailed Review of the AS13100 additional requirements to the AS9100 standard:  Clauses 1-8.3  
Topics & In-Class Exercises: Supplier Type and Supplemental Requirements & Appendix B;  AS9115 Applicability; Compliance Assessment; Human Factors RM 13010; ISO 31000 Risk Management; RM 13003 MSA; MSA Acceptance Limits; Auditor Qualifications – Training; Delegations of Product Release Verification; Retention of Documented Information; Prevention of Counterfeit Parts AS 6174; APQP & PPAP in Design; Design FMEA Process; AS9146 FOD; Design Phases RM 13008; Design for ‘X’ (DfX:  DfM, DfA, DfS, DfC); Critical Items & Key Characteristics;  
Activity #2:    MSA Repeatability Mitigation RM 13003

Activity #3a:  Design FMEA  RM 13004

 
Estimated time for day 1 7.5 hours in class

Day 2

Part 3 Cont. Detailed Review of the AS13100 additional requirements to the AS9100 standard:  Clauses 8.4 – 10
Topics & In-Class Exercises:  Sub-tier Assessment Process (SCMH); Audit Types RM 13005;  ITAR/EAR; D&D Software Requirements Specification (SCMH); Process FMEA; PFMEA/Control Plan process RM 13004; AS9102 FAI;  Rework & Repair of NC Product RM 13011; Process Control Methods RM 13006; Process Capability Cp, Pp, Cpk, RM 13006; Alternate Inspection Frequency Plans RM 13002; Appendix C Training Syllabus Process Controls RM 13006; Internal Audit Types & Frequencies; Quality Audits – Production Process over 3-years RM 13005; 8D Structured Problem Solving RM 13000; Human Factors in Problem Solving RM 13010;  Lean Six Sigma & 5S; AS 9145 2016-11 & APQP Process Flow;  
Activity #3b:  Process FMEA RM 13004

Activity #4:  8D Problem Solving Case Study

 
Part 4 AS13100 Chapter B  AS9145 Supplemental Requirements  
Topics & In-Class Exercises:  APQP and PPAP Process Flow Diagram; APQP & PPAP Timing Chart & Events; DFMEA RM 13004; Process Flow Diagram RM 13004; Control Plan RM 13004; Production Preparation Plan AS 13100; Alternate Inspection Plan RM 13002  
Estimated time for day 2 7.5 hours in class
Day 3
Part 4 cont. AS13100 Chapter B  AS9145 Supplemental Requirements cont.  
Topics & In-Class Exercises:  Pre-Launch Control Plan RM 1345; MSA GRR RM 13003; AESQ PPAP Elements AS13100; PPAP Coordinator and CAR3 Training RM 12145; PPAP Submission/Retention Levels; PPAP Elements and RM References AS13100; Typical Use of PPAP Elements RM 13145; Supply Chain Risk Management RM 13145; APQP Assurance Actions AS13100; Robust Statistical Evaluations Chart RM 13006;  
Part 5 Core Defect Prevention Quality Tools APQP & PPAP  
Topics & In-Class Exercises:  APQP Phase 1-5 Resource Manuals References; Design FMEA Severity/Occurrence/Detection Ranking Tables RM 13004; DFMEA Potential Causes & Controls RM 13004; Critical Items, Key Characteristics, Special Requirements AS9100; Process Flow Diagram, Defect Detection RM 13004; PFMEA Severity, Occurrence, Detection Rating Tables RM 13004; Control Plan Inputs/Defect Detection RM 13004; Cp and Cpk Calculations  
     Activity #5:  Use of PPAP Submissions in Supplier Control RM 13145  
Estimated Time for Day 3 7.5 hours

Internal Auditor Class

With Live Audits

Days: 3 • CEU Hrs: 2.4
Time: 7:30 a.m.- 6:30 p.m. MST
Audience: Beginner to Advanced

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.
This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 Rev D standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Probitas Authentication AS13004

Who Should Attend?

Individuals who will perform audits to AS9100:2016 Rev D Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 Rev D registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the 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.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the AS9100:2016 Rev D requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • 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 and Definitions

  1. Quality industry vernacular from AS9100:2009, 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 AS9100:2009

  1. Demystifying the AS9100:2016 Rev D standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100:2016 Rev D 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

Internal Auditor Class

With Live Audits

Days: 3 • CEU Hrs: 2.4
Time: 7:30 a.m.- 5:30 p.m.
Audience: Beginner to Advanced

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 Rev D standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Probitas Authentication AS13004

Who Should Attend?

Individuals who will perform audits to AS9100:2016 Rev D Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 Rev D registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the 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.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the AS9100:2016 Rev D requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • 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 and Definitions

  1. Quality industry vernacular from AS9100:2009, 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 AS9100:2009

  1. Demystifying the AS9100:2016 Rev D standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100:2016 Rev D 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

Days: 2

Time:  7:30 AM- 4:30 PM MST

AXEON’s training courses begin with your objectives in mind. Before any training begins the instructor must have an objective to deliver your desired outcome. If the course does not have a specific objective, students can go through the motions with little added value. AXEON’s course setup begins with a candid discussion of your needs and expectations with the course instructor to develop specific areas of focus for the class. Below is a general outline for the course and topics that will be covered.

Overview

Statistical process control (SPC) procedures help you monitor process behavior. One of the staple SPC tools used by quality process analysts, improvement associates, inspectors and more is the control chart. Axeon’s statistical process control training will walk you through the details of control charting and other SPC procedures and how to apply them within your organization.

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

 

Agenda

  • Sources of Variation
    • Common and Special Cause Sources
    • Detecting Special Cause Sources
  • Charts: Xbar and R
    • Differences Between Measurements and Averages
    • Computing Control Limits and Charting
  • Other Charts
    • Individuals & Moving Ranges
    • Xbar and S Charts
    • Charts for Short Production Runs
  • Attribute Charts (p, np, c, u)
    Chart Interpretation

    • Type I and Type II Errors
    • Guidelines for Analysis of Charts
    • Out of Control Signals
  • Sensitivity
    • Impact of Sample Size on Chart Sensitivity
    • Determining Sample Size
  • Process Capability
    • Capability ratio – Cr
    • Performance Ratio – Pr
    • Capability Index – Cp
    • Performance Index – Pp
    • Process Capability – CpK
    • The Standard Normal
    • Z Values
    • Computing Proportion Defective

Days: 2 

 7:30 AM- 4:30 PM MST

Corrective Action Training – Root Cause & CAPA 

In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.

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.

This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build 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 an in depth understanding of the 8-step approach for CAPA’s.

 

Agenda

Day 1

  • Overview of Root Cause & Corrective and Preventive Action
  • 8-Step Closed-Loop Process
  • Typical Problems with Root Cause Analysis
  • Why most problem-solving models don’t get to the root cause and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking
  • Responsibilities for Root Cause and Corrective/ Preventive Action
  • Quality, Design, Frontline Management, Supervisors, Worker
  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
    • Activity #1 – Detailed problem descriptions
  • Step 3: Containing the problem
    • Activity #2 – Containment Potential
  • Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data analysis tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
  • Data Collection
    • Population versus sampling; options for sampling
    • Check sheets, graphs, and tables for discrete data collection
    • Surveys, interviews, and field observation for opinions or less precise data
  • Activity #3 – “5 why” method
  • Activity #4 – Ishikawa or Cause & Effect Diagram
  • Activity #5 – FMEA (Failure Modes Effect Analysis)
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
    • What, Who, When Plans
    • Short Term, Medium Term, Long Term Actions
  • Step 7: Verifying corrective action effectiveness
    • Layered Process Auditing
    • Charting: Paynter Charts
    • Quality Assurance SPC
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement

Day 2

Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools

  • “Live” Case Studies and Application
  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
  • Step 3: Containing the problem
  • Step 4: Identifying the root cause or causes
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report
  • New requirements for Corrective Action “documented information”

Review & Exam

Risk Management for AS13004

Days: 2 

 7:30 AM- 4:30 PM MST

 

AS13004 Overview

This class teaches participants the Aerospace Risk Requirements (per AS9100, 9110, and 9120) as well as the specific requirements for Operation Risk as defined in AS13004 PFMEA and Control Plans.  The course follows a well-organized, systematic approach to Identify, Assess, and Mitigate Risks that impact Aerospace organizations and the risks to their customers and stakeholders. While Risk Management is a basic requirement of ISO 9001, the Aerospace standards incorporate all of these requirements and add further requirements to make aerospace products and services safe and effective throughout the Supply Chain. Further, with reduced risks inherent in the Design and Manufacture of aerospace articles, the costs associated with their manufacture should be reduced.

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 Risk Management Training - Airplane

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

 

AGENDA

Day 1

  • Risk terminology
  • Four-step Risk Management process outlined in ISO 31000
  • Risk-based Thinking requirements of ISO 9001:2015 and AS9100D
  • Strategic vs. process risk management
  • Tools, methods, and a streamlined approach for addressing risk-based thinking requirements.
  • Hands-on exercises

Day 2

  • Aerospace risk terminology
  • Overview of APQP and PPAP risk tools: Process Flow Diagrams, PFMEA’s and Control Plans
  • How to develop a Process Flow Diagram (identifying process risks)
  • Guidelines for performing a Process Failure Modes and Effects (FMEA) analysis
  • Creating an effective Control Plan used to manufacture and control and resolve ongoing process risks
  • Detailed hands-on case study developing an FMEA analysis, with tools for completing each stage
  • Requirements for Operational Risk Management
  • Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans
  • Guidance on using AS13004 methodology to meet Operational Risk Management requirements

Probitas Authentication AS13004

Days: 2 • CEU Hrs: 1.9

 7:30 a.m.- 5:30 p.m.

Audience: Beginner to Advanced

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class teaches Internal Auditing for ISO 9001:2015 Quality Management Systems and makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO 9001:2015 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Who Should Attend

Individuals who will perform audits to ISO 9001:2015 Standards or Quality Management Systems, individuals assisting their organizations toward ISO 9000 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the ISO 9001:2015 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the ISO 9001:2015 requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • 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 class mates (industry professionals)
  • Self-assessment of audit skills and internal audit programs Exercise #1

Part 2: Quality Terminology and 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
  • Terminology Exercise #2

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
  • Conducting Audit Interviews Exercise #9
  • Exercise #10 Quality event case studies

Part 6: The Audit Process: Audit Skills and 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 and audit report
  • Exercise #15 Writing Non-Conforming Reports
  • Exercise #16 Conducting a Closing Meeting

Review and Examination for Certificate

Days: 2 • CEU Hrs: 1.9

Time:  7:30 a.m.- 4:30 p.m. MST

Audience: Beginner to Advanced

ISO 9001 & AS9100 Internal Auditor Training Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Who Should Attend?

Individuals who will perform audits to the AS9100:2016 or ISO 9001:2015 Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

ISO 9001 & AS9100 Internal Auditor Training

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the AS9100:2016 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

ISO 9001 & AS9100 Internal Auditor Training Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the AS9100:2016 requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • 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 and Definitions

  1. Quality industry vernacular from AS9100:2009, 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 AS9100:2009

  1. Demystifying the AS9100:2016 Rev D standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for the application of AS9100:2016 Rev D 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 Quality event 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

Part 7:  The Audit Process:  Finalizing the Audit

  1. Writing the audit report
  2. Opening and Closing Meetings
  3. Exercise #14 Writing and audit report
  4. Exercise #15 Writing Non-Conforming Reports
  5. Exercise #16 Conducting a Closing Meeting

Review and Examination of Certificate

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.

Application of risk management to medical devices

 

2-Day Schedule: 7:30 AM – 4:30 PM MST

 

Audience: Beginner to Advanced
RTP Certified Training

ISO 14971 Training Overview

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Medical Device Manufacturers, these same techniques learned in this ISO 14971 training can be used regardless of the products or services offered by your organization.

 

Who Should Attend?

  • Anyone who needs to develop and implement a comprehensive Risk Management
  • Program meets requirements for ISO 14971:2019
  • Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
  • Quality Managers
  • Engineering 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.
ISO 14971 Training - Medical Device Risk Management

 

Agenda

Day 1 

  • Risk terminology and theory from ISO 14971 and ISO 13485
  • History of risk management and relationship with Corrective and Preventive Actions
  • Requirements of ISO 14971
  • Design of framework for managing risk
  • 4.3.2 Establishing risk management policy
  • Integration into organizational processes
  • Establishing internal communication and reporting mechanisms
  • Establishing external communication and reporting mechanisms
  • Implementing risk management
  • Implementing the framework for managing risk & risk management process
  • Continual improvement of the framework
  • Communication and consultation
  • Establishing the internal and external context
  • Establishing the context of the risk management process
  • Defining risk criteria
  • Risk assessment
  • Risk identification
  • Risk analysis
  • Risk evaluation
  • Risk treatment
  • Selection of risk treatment options
  • Preparing and implementing risk treatment plans
  • Monitoring and review
  • Recording the risk management process
  • Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis

Day 2

  • Guidelines from ISO 14971
  • Techniques – Risk Management
  • Selection of risk assessment techniques
  • Selection of techniques
  • Availability of Resources
  • The Nature and Degree of Uncertainty
  • Complexity of risk
  • Application of risk assessment during life cycle phases
  • Types of risk assessment techniques
  • Flow charts and process mapping
  • Brainstorming
  • Risk Checklists
  • Delphi Method
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis (Event Tree Analysis)
  • HAZOP & HACCP
  • Cause & Effect with 5-Whys & 7-M
  • Preliminary hazard analysis
  • Risk Ranking and Filtering
  • Case Studies with application
  • Organization’s Risk Procedures and Tools
  • Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
  • Risk Applications in the Aerospace organization
  • Internal Audit
  • Training
  • CAPA System
  • Supplier Selection & Control
  • Outsourcing – Special Processes
  • Facilities and Equipment
  • Design & Development
  • Production and Process Controls
  • Process Validation and Re-Validation
  • Servicing
  • Design FMEA Case Study
  • Various Risk Case Studies
  • Organization’s Case Studies
  • Statistical Methods
  • Test

Day 1-2: 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.

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

Cybersecurity Maturity Model Certification

Days: 2 

 Time: 7:30 AM- 3:30 PM MST

Audience: Beginner to Advanced

Overview

The CMMC Foundations training course enables participants to understand the fundamental concepts and principles of the CMMC model.

Who Should Attend

  • Individuals interested in being part of the CMMC ecosystem
  • Individuals seeking to gain knowledge about the CMMC model
  • Individuals interested in using the CMMC model
  • Suppliers of the Department of Defense (DoD) and Defense Industrial Base (DIB) and others seeking CMMC certification

Prerequisites

There are no required prerequisites to participate in this training course.

Course Objectives

  • Understand the basic concepts, definitions, and approaches of the CMMC model
  • Get acquainted with the CMMC maturity levels, domains, processes, and practices
  • Develop a general understanding of how the CMMC model could be applied in the supply chain of the DoD and the DIB sector

Educational Approach

  • Contains lecture sessions illustrated with graphics, examples, and discussions
  • Encourages interaction between participants by means of questions, suggestions, quizzes, etc.
  • Includes quizzes which are a simulation of the questions of the final exam

Day 1

Introduction to the CMMC ecosystem and the CMMC model

Day 2

CMMC practices, assessment process, and code of professional conduct.

Exam and Certification:

The “CMMC Foundations” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP) requirements. It covers the following competency domains:

Domain 1: Fundamental concepts of the CMMC model, CMMC ecosystem, and code of professional conduct
Domain 2: CMMC domains, processes, practices, and assessment process

Upon the successful completion of the exam, you can apply for the credential shown in the table below:

Credential Exam Professional Experience CMMMS project experience Other requirements
PECB Certified CMMC Foundations PECB CMMC Foundations exam None None Signing the PECB Code of Ethics

 

Miscellaneous information:

  • Participants will be provided with the training course material containing over 200 pages of explanatory information and quizzes.
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, candidates can retake the exam once for free within 12 months of the initial exam date.
  • The PECB CMMC Foundations credential is not approved by the CMMC-AB. It is a PECB credential that demonstrates the candidate’s understanding and knowledge of the basic concepts of the CMMC model.

Automotive Core Tools Training for Process and System Auditors

Days: 2

Overview

In order to ensure a high initial quality of audit activities in the companies and the entire supply chain, the appropriate competence of the auditors employed in relation to the respective methods is required. The IATF 16949 also clearly highlights this requirement for the competence of the auditors. The efficient approach during the audits is an important success factor. This training focuses on typical audit situations along the Automotive Core Tools.

Who Should Attend?

This training is intended for employees from the Quality department and/or other departments of the organization who wish to acquire knowledge about the main Core Tools of the Automotive Industry or develop their skills in performing typical auditing situations in this context. This two-day training course is also aimed at qualified VDA 6.3 process auditors who wish to apply for an extension, as well as prospective VDA 6.3 Process and IATF System auditors who are seeking qualification.

Course Objectives

The participants strengthen their technical competence and deepen their knowledge on the basic of typical auditing situations in the context of quality methods, focusing on an efficient approach. Both the assessment of the technically correct application of the respective methods and the case-specific assessment of typical situations are a central component of the training.

Methods and Duration:

During the training, technical lectures on the essential Core Tools (APQP, VDA 2 / PPAP, FMEA, VDA 5 / MSA, Cmk / Ppk / Cpk / SPC and 8D) will be alternated with exercises in typical examples.
The focus is on practical application by the participants. Here, group work, individual exercises, question and answer exercises, as well as group discussions will be held.
The exploration of the course contents will alternate between some thematic exhibitions and practical exercises based on the professional reality of the participants.
Theoretical-practical training, with application to real cases, lasting 16 hours (2 days).

Advanced Product Quality Planning and Production Part Approval Process- APQP and PPAP Training

Days: 2

Time: 7:30 AM – 4:30 PM MST

Overview

This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins with conceptual product needs and extends through product definition, production planning, product and process validation (i.e., PPAP), product use, and post-delivery service. This standard integrates and collaborates with the requirements of the 9100, 9102, 9103, and 9110 standards.

The requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.

Learning Objectives 

  • 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 and PPAP Training

Who Needs an APQP and PPAP Training?

  • 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.

 

Agenda

 

1 Introduction
2 History, Aerospace requirements for APQP/PPAP
3 Activity #1  Terminology
4  AS9145  Clause 4.1 – 4.2  General Requirements, Start-Up
5 Workshop #1  SCMH  Checklists
6 AS9145  Clause 4.3  Phase I Planning
7 Workshop #2
8 AS9145  Clause 4.4  Phase 2  Product Design & Development
9 Workshop #3
10 AS9145  Clause 4.5  Phase 3  Process Design & Development
Day 1

 

Day 2
1 AS9145  Clause 4.5  Phase 3  Process Design & Development
2 Workshop #4
3 AS9145  Clause 4.6  Phase 4  Product & Process Validation
4 AS9145  Clause 4.7  Phase 5  Ongoing Production, Use, Post Delivery
5 Workshop  #5
6 AS9145  Clause 5.1 – 5.4   PPAP
7 Workshop  #6
8 In-Class Case Study

AS13000 Training: Problem-Solving Requirements for Suppliers

Days: 2

Time:  7:30 a.m.- 4:30 p.m. MST

Overview

As Root Cause CAPA for Aerospace, an AS13000 training is a must-have. If you are a Boeing, Airbus, or other top OEM supplier, you need this class! All suppliers for the top OEM’s are required to have an 8D Practitioner. This course fulfills the training and testing requirements to become an 8D Practitioner.

AS13000 defines the Problem-Solving standard for suppliers within the aero-engine sector, with the Eight Disciplines (8D) problem-solving method being the basis for this standard.

This 2-day course provides students with a comprehensive and standardized set of tools to become an 8D practitioner and meets all the requirements of “training syllabus” (see AS1300 APPENDIX C). Successful application of 8D achieves robust corrective and preventive actions to reduce the risk of repeat occurrences and minimize the cost of poor quality. This is essential to enable long-term customer-supplier relationships and positively contributes towards zero defects and customer satisfaction.

This course includes the practical application of each of the 8D disciplines.

AS13000 Training
Root Cause Analysis

Learning Objectives:

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


Who Should Attend:

An AS13000 training is a requirement for Aerospace Suppliers of any top OEM. Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-D process.

Agenda

Day 1

  • Introduction & 8-D Practitioner Requirements
  • Problem Solving Terminology and Definitions
  • Activity #1 Standard Terminology
  • Review of Standard
  • Requirements for an 8-D Practitioner Appendix C
  • Topics: Problem Solving Form Append. A, Team Dynamics, Questioning and Listening Techniques, Basic Tools overview
  • Methods: Appendix B: Questions, Brainstorming, Comparison Sheets, Check Sheets/Talley Sheets, Histograms, Scatter Diagrams, Run and Control Charts, Pareto Analysis, Human Factors, Analysis Techniques, Root Cause Chain
Case Studies:
  • Activity #1.1 Inputs for Process Flow Diagram
  • Activity #1.2 Is/Is Not and 8D Form
  • Case Studies Cont. :
  • Activity #2.1 5W2H Define the Problem
  • Activity #2.2 Define the Problem 8-D form
  • Activity #2.3 PCB CAR Review/8-D D2 & D3
  • Activity #3.1 Ishikawa – Fishbone

Day 2

  • Case Studies Cont. :
  • Activity #2.1 5W2H Define the Problem
  • Activity #2.2 Define the Problem 8-D form
  • Activity #2.3 PCB CAR Review/8-D D2 & D3
  • Activity #3.1 Ishikawa – Fishbone

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

1/2-Day How To Perform Remote Audits

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

Days: .5

Time: 7:30 AM- 11:30 AM MST

Audience: Beginner to Advanced

Overview

This half (1/2) day training will inform you on recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.

You’ll receive an understanding of the following:

  • The FDA’s announcement on January 31, 2024, to integrate ISO 13485:2016 into the new 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 integration of ISO 14971 – Risk Management Files in the QMS
  • 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

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

Objectives

  • Understand the primary changes from QSR to the QMSR
  • Understand the importance of creating a Quality Plan to effectively plan for the changes
  • Understand the Technical Documentation requirements compared to the obsolete Technical File requirements
  • Re-emphasize the risk management requirements of ISO 14971:2019 and ISO/TR 24971:2020
  • Identify the necessary steps as to prepare an organization to transition to the QMSR requirement
  • The importance of MDSAP

Agenda

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

Course Certificate

Participants will receive a 21 CFR 820 & ISO 13485:2016 QMSR Training Certificate.

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.

Class is subject to minimum participation requirements.

 Days: 1

Time: Day 1 7:30 a.m.- 4:30 p.m.

Audience: Beginner to Advanced

Overview:

This course introduces you to the Nadcap process and helps you get prepared for the certification process including the onsite assessment performed by the Nadcap auditor.  You’ll learn about Nadcap and how to effectively work within the Nadcap system.
 

Who Should Attend:

Individuals responsible for obtaining or maintaining Nadcap accreditation for their organizations.  Quality directors, managers, process owners, quality engineers, auditors, laboratory personnel, and production management.

Prerequisites
There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals.

Course Objectives

  • Learning about Nadcap, its purpose, and documentation.
  • Prepare for Nadcap accreditation.
  • Understanding and application of Nadcap requirements.
  • Preparing for and performing internal audits to Nadcap criteria.
  • Preparing for the Nadcap audit
  • How to respond to Nadcap corrective actions.

NADCAP Training Outline:

  • Introduction to Nadcap
    • History
    • Purpose
    • Documents
    • Meetings
    • Participation
    • Requesting certification etc…
  • Preparing for Nadcap Certification
    • Documenting requirements
    • Self-audits
    • Self-audit frequency
  • The Nadcap Audit Process
    • Stages of the audit
    • ITAR
  • Nonconformance Report (NCR) Response Methodology and Process
    • Response Time Frame
    • Cycles explained
    • Components of the response

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

Days: 1

Time: 7:30a.m.-4:30p.m. MST

What are ITAR and EAR?

ITAR (International Traffic in Arms Regulations) and the EAR (Export Administration Regulations) are export control regulations run by different departments of the US Government.  Both of them are designed to help ensure that defense-related technology does not get into the wrong hands.  An export license is a general term for both ITAR and EAR-controlled items in which the US Government has granted permission to transport or sell potentially dangerous items to foreign countries or parties.

Obtaining EAR and ITAR Compliance

To be ITAR or EAR compliant, a manufacturer or exporter whose articles or services appear on the USML or CCL lists must register with the U.S. State Department’s Directorate of Defense Trade Controls (DDTC). ITAR and EAR compliance can be problematic for a global corporation because the data related to a specific type of technology may need to be transferred over the Internet or stored locally outside the United States to make business processes flow smoothly. It is the responsibility of the manufacturer or exporter to take the necessary steps to certify that they are in compliance with the regulations.

Export control laws provide for substantial penalties, both civil and criminal.  Failure to comply with ITAR can result in civil fines as high as $500,000 per violation, while criminal penalties include fines of up to $1,000,000 and 10 years imprisonment per violation.  Under EAR, maximum civil fines can reach $250,000 per violation. Criminal penalties can be as high as $1,000,000 and 20 years imprisonment per violation.

ITAR:

The Department of State is responsible for the export and temporary import of defense articles and services governed by 22 U.S.C. 2778 of the Arms Export Control Act and Executive Order 13637. The International Traffic in Arms Regulations (“ITAR,” 22 CFR 120-130) implements the AECA.

The more stringent of the two sets of regulations was written for articles with direct defense-related applications.  Articles specifically designed or otherwise intended for military end-use are enumerated on the United States Munitions List (USML) or the Missile Technology Control Regime (MTCR) Annex and therefore controlled by International Traffic in Arms Regulations (ITAR) which is administered by the Directorate of Defense Trade Controls (DDTC) at the State Department.  Items, services, and information are all covered by the ITAR regulations.  The most controlled items are Significant Military Equipment (SME) which have “capacity for substantial military utility or capability” such as tanks, high explosives, naval vessels, attack helicopters, etc which are noted on the USML with an asterisk.  Some examples include; an export license (DSP-5), exchanging technical emails or teaching how to repair an ITAR-covered item which requires a Technical Assistance Agreement (TAA), and allowing a foreign company to manufacture an item requires a Manufacturing License Agreement (MLA).

EAR:

Most other items not specifically listed in the USML, but with the capability to be used for either civilian or military purposes are considered “dual-use” and controlled under the Export Administration Regulations (EAR) which is administered by the Bureau of Industry and Security (BIS) at the Department of Commerce (DoC).   The Commerce Control List (CCL) is the equivalent list at the DoC to the State Department’s USML.  The CCL specifically controls for Chemical & Biological Weapons, Nuclear Nonproliferation, National Security, Missile Technology, Regional Stability, Firearm Convention, Crime Control, and Anti-Terrorism.  The level of control depends on the country being exported to, destination party, end-use, and Export Control Classification Number (ECCN).  Specifically, there are “600 Series” and “500 Series” items that are more strictly controlled than the rest of the CCL, but less strictly controlled than the articles on the USML.

Who should attend?

This introductory course is for 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, and legal and financial advisors.

Why go to this class?

  1. ITAR isn’t easy- you will need a guide to help you through.
  2. Online courses require no travel.
  3. This 1-day training is only on our calendar six times a year.
  4. Everything your company manufactures or offers services on is either subject to the ITAR or EAR Regulations.
  5. Failure to comply with ITAR can result in civil fines are as high as $500,000 per violation, while criminal penalities include fines of up to $1,000,000 and 10 years imprisonment per violation.

 

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

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

 

_______________________________________________________________________

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

 

Days: 1 • CEU Hrs: 0.8

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

Audience: Beginner to Advanced

Overview

The aviation, space, and defense industry established the International Aerospace Quality Group (IAQG).  The IAQG strives to improve quality and safety while reducing cost throughout the value stream. The AS9102 Rev C First Article Inspection standard applies to the complete value stream.

The FAI process requirements are used at all levels of the supply chain by organizations around the world.  This standard provides a consistent process and documentation requirements for verification of aviation, space, and defense product.

Its use should result in improved: a) quality, b) schedule, and c) cost performance by: the reduction or elimination of organization-unique requirements and wider application of good practices.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the AS9102 standard. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Understand “When” and “How” to use the AS9102 Standard.
  • Help you develop the knowledge and skills required to complete the AS9102 Forms.
  • ‘Improve your understanding of the International Standard.
  • Learn how to interpret the requirements of the Standard and compare to your own Standard Operating Procedures (SOPs).

Agenda

  1. Introduction to: the Course Objectives and the Purpose, Intent and Proper Application of First Article Inspection
    • 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
  2. The IAQG and Standards Development
  3. AS9102 Terminology
    • Terminology Game and Understanding the Forms lingo
  4. Comprehensive Review of the AS9102 Rev C Requirements and How to Complete the FAIR per Appendix B
    • The Required (R), Conditionally Required (CR) and Optional (O) boxes
    • Forms Review and Detailed Requirements for each Form and Box
  5. Understanding the Reporting and Objective Evidence Required in the FAIR (Firsts Article Inspection Report)
    • In-Class evaluation of Examples of Completed Forms 1, 2 and 3
    • The Planning, Activities and Documentation necessary to complete the AS9102 Forms
  6. Good Practices for Completing and Reviewing FAIRs
    • In-Class Exercise of Evaluating Drawings and Documenting the FAI Objective Evidence
    • In-Class Exercise Reviewing Completed FAIRs
  7. Completing the Forms from Source Documents. How to divine the necessary information and proper presentation of information in Forms: 1, 2 and 3
    • Case Study: Using Drawing, Certificates of Conformance, Bill of Materials to Complete a full FAI Report
    • Case Study: Missing information and sources of Objective Evidence for the FAI Report
  8. FAIR Checklist Items for Reviewing and Approving Organization and Supplier FAIR

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

1-Day AS6500 Manufacturing Management Program

Days: 1

 7:30 AM- 4:30 PM MST

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, and Supplier Quality and Management

Overview

The AS6500 standard is applicable to all phases of the system acquisition life cycle. It is intended for use on all programs with manufacturing content. It requires proven manufacturing management practices with the goal of delivering affordable and capable systems to the extent that it is invoked contractually.  The agreement between the customer and the organization shall include the manufacturing management requirements in AS6500 based upon tailoring the requirements of this standard to address the program situation.

 

Many international publications are referenced within this 16-page standard to give additional insight in meeting customer requirements and enhancing the performance of your current Manufacturing Management System.

 

Learning Objectives:

  • Review and understand the requirements, application and conformance declaration to the AS6500 standard
  • 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.
  • 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
  • Practical workshops to enhance your understanding and successful application of this standard

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

 

AGENDA

Day 1

Part 1 Introductions
Part 2 History, Purpose, Terms and Definitions
      Activity #1A & 1B:  Terminology
Part 3 Detailed Review of the AS6500 Standard Requirements
Topics & In-Class Exercises: MS Objectives, Producibility Analysis: Trade Curves, Design for Manufacturing and Assembly, MIL HDBK 727, Key and Critical Characteristics: Process Flow and Control Plans; PFMEA:  Activity #3 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, Cp and Cpk Process Capability, Activity #4:  Cp and Cpk, FAI/FAT Supplier Management and Quality: PPAP
Activity #2:    Management System Objectives
Activity #3:  Process Flow Diagram and PFMEA
Activity #4:  Calculate Cp and Cpk (Process Capability)

 

Learn to identify and prevent the use of counterfeit parts with AS5553 and AS6174

Days: 1 • CEU Hrs: 4.8
Time: 7:30 a.m.- 4:30 p.m. MST
Audience: Beginner to Advanced

Overview

  1. Discuss Industry Problems with Counterfeit Parts and industry efforts on Counterfeit Part Prevention
  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 Product
  5. Discuss Methods for Auditing Counterfeit Parts Prevention (CPP) within AS 9100C/AS 9120B (ISO 9001:2015)
  6. Internal Audits

Who Should Attend?

  • End User (government or commercial using platforms, systems, and/or equipment e.g. UK MoD, US DoD, NASA etc.)
  • Platform Integrator
  • Systems Integrator
  • OEM (System level e.g. Radar, Lower Level e.g. Power Supply)
  • CEM (Board Level)
  • Product Maintenance/Repair Organization
  • Material Procurement Organizations (e.g. BPO organizations etc.)
  • Others (any organization contracted by a customer to comply or who chooses to use to enhance its processes)

Agenda

  • The training of personnel
  • The inspection and testing of electronic parts
  • Processes to abolish counterfeit parts proliferation
  • Processes for maintaining electronic part traceability
  • Use of suppliers that are the original manufacturer, or an authorized dealer
  • Reporting and quarantining
  • Methodologies to identify suspect counterfeit
  • Design, operation, and maintenance of systems
  • Flow down of counterfeit detection and avoidance requirements
  • Process for keeping continually informed of current counterfeiting information and trends
  • Process for screening GIDEP reports and other credible sources
  • Control of obsolete electronic parts

Online, Interactive, Instructor-Led AATT Prep Class

 

Days: 1

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

Overview

Serious about passing the AATT (Aerospace Auditor Transition Training) training? Sign up for the class!

This AATT Prep Class will help you prepare for the 4-day AATT AS9100 IAQG Sanctioned training.

If you are going to take the AATT class you might as well pass it. Select this class and Axeon will help you prepare to pass the AATT course.

Languages: English (other IAQG-approved languages to be released separately)

Who Should Attend?

  • Individuals looking to pass the AATT AS9100 IAQG Sanctioned 4-day Aerospace Auditor Transition Training