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Pick 4 Bundle - $3800
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With Axeon Pick 4 Training Packages, you can use your 2018 training budgets 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 = $3800

Save up to $2850

Pick 3 Bundle - $2985
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With Axeon Pick 3 Training Packages, you can use your 2018 training budgets 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

Pick 2 Bundle - $2190
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With Axeon Pick 2 Training Packages, you can use your 2018 training budgets 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

Combined ISO 14001 & ISO 45001 Systems Lead Auditor $2295
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COMBINED ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEMS
LEAD AUDITOR WITH ISO 45001:2018 OCCUPATIONAL HEALTH AND
SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR

We teach you how to use auditing to improve your organization

 Days: 5 • Price: $2295

Monday-Friday

Each 4-day class covers:

  • Environmental Management and Sustainability
  • Understanding and Reducing Environmental
    Impacts
  • Comparison of EMS Standards
  • Assessing Environmental Impacts
  • EMS Policy, Objectives and Targets
  • Audit Planning and Preparation
  • Environmental Legislation and Regulation (USA)
  • Documenting the EMS
  • Performing and Reporting the Audit
  • Environmental Education and Training
  • Corrective Action and Follow-up
  • Monitoring, Reporting and Improving
    Environmental Performance
  • Registration, Accreditation and Auditor
    Certification
  • Requirements of BS OHSAS 18001
  • Application of OHSMS to various industries
  • Establishing a process-based OHSMS
  • Audit Planning and Preparation
  • OHSAS Legislation and Regulation (USA)
  • Documenting the OHSAS
  • Performing and Reporting the Audit
  • OHSAS Education and Training
  • Monitoring and Improving OHSMS

The Workshops include:

  • Assessing Environmental Impacts
  • Environmental Policy
  • Objectives and Targets
  • Writing a Checklist
  • Opening Meeting
  • Audit Investigation
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action
  • Assessing and Mitigating Risks
  • Preparing for an audit
  • Writing a Checklist
  • Opening Meeting
  • Audit Investigation
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Attendees successfully completing the examinations provided inExemplarGlobalLogo conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

EM – Environmental Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
OH – Occupational Health and Safety Management Systems

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

While ISO 14001 and ISO 45001 is used as the model for teaching audit, this class enables students to develop and apply auditing skills using any recognized 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.

AS9120 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) $600 add-on
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AS9120 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) 

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 Axeon.
  • 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.

AS9110 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) $800 add-on
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AS9110 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) 

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.
  • 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.

AATT AS9100 IAQG Sanctioned 4-day Aerospace Auditor Transition Training - $2590
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AS9100 IAQG Sanctioned Aerospace Auditor Training (AATT)

 

IAQG-sanctioned 9100:2016 AATT Online and Instructor-Led Bundle

Axeon is certified by Probitas Authentication and is an IAOG recognized Training Provider.  This course is certified by the IAOG 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 the applying the 9100:2016 requirements in audit situations using 9101:2016 forms and in consideration of 9101:2016 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.

Length:

  • Online:  10-15+ hours
  • Instructor-led: 4 days

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

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, 9101:2016 requirements, and 9101 Forms.

Standard Documents

  • It is recommended that you purchase the official (published) version of 9100:2016, 9101:2016, 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.
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 9101:2016 forms and the conformity with 9101:2016 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 9100:2016 and your ability to use the 9101:2016 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.

Instructor-Led Training

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

WHO SHOULD ATTEND

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

REQUIREMENTS FOR SUCCESSFUL COMPLETION

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

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.

5-Day Lead Auditor IATF 16949:2016 (TS 16949) - $1995
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IATF 16949:2016 Lead Auditor Training for Automotive Quality Management Systems

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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

5-Day ISO 17025 Lead Auditor with Testing and Calibration Focus: $1995
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ISO 17025 36 (hr) Lead Auditor

 

Days: 5  • Price: $1995

 

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 17025:2005 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 17025:2005 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 17025:2005 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 17025:2005 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 17025:2005
  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 ACLASS

5-Day FSSC ISO 22000 Food Safety Lead Auditor Certified - $2045
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FOOD SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR COURSE USING
ISO 22000:2005

We teach you how to use auditing to improve your organization

 Days: 5 • Price: $2045

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 5-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 inExemplarGlobalLogo 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.

5-Day AS9110 Rev C Aerospace-MRO Probitas Certified Lead Auditor - $2095
+

AS9110 Rev C AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR

We teach you how to use auditing to improve your organization

 Days: 5 • Price: $2095

Monday-Friday

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


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.

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This AS9110 course is being offered through Quality Management International, Inc. (QMII), a Probitas Authentication certified and IAQG certified Training Provider.

5-Day AS9100 Rev D Aerospace & ISO 9001 - Probitas Certified Lead Auditor - $2095
+

ISO 9001 & AS9100:2016 Rev D AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR

AS9100-Rev-D-Certified-Training

We teach you how to use auditing to improve your organization

 Days: 5 • Price: $2095

Monday-Friday

  Each 5-day class covers:

  • Understanding of Quality Management Principles
  • Interpreting the Requirements Of ISO 9001
  • Interpreting the Requirements Of AS9100
  • 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


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

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.

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4-Day NQA-1 Lead Auditor Training $1995
+

4-Day NQA-1 Lead Auditor Training

 

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 One

  • Introduction and Overview
  • Codes and Standards
  • Codes and Standards (cont.)
  • Structure of QA Programs
  • Structure of QA Programs (cont.)

 

Day Two

  • Auditing Techniques
  • Auditing Techniques (cont.)
  • Auditing Process
  • Auditing Process (cont.)

 

Day Three

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

 

Day Four

  • Review
  • Examination
  • Closeout & Class Evaluation

 

4-Day ISO 9001:2015 Lead Auditor $1995 Recognized by Exemplar Global
+

ISO 9001:2015 Quality Management Systems Lead Auditor Course 

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

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 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
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 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 examination satisfies the training requirements for certification by Exemplar Global as a lead auditor.

4-Day ISO 45001 Certified Lead Auditor - $1995
+

OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR
WITH ISO 45001

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

Each 4-day class covers:

  • Requirements of ISO 45001
  • Application of OHSMS to various industries
  • Establishing a process-based OHSMS
  • Audit Planning and Preparation
  • OHSAS Legislation and Regulation (USA)
  • Documenting the OHSAS
  • Performing and Reporting the Audit
  • OHSAS Education and Training
  • Corrective Action and Follow-up
  • Monitoring and Improving OHSMS
  • Registration, Accreditation and Auditor Certification

The Workshops include:

  • Assessing and Mitigating Risks
  • Preparing for an audit
  • Writing a Checklist
  • Opening Meeting
  • Audit Investigation
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Attendees successfully completing the examinations provided inExemplarGlobalLogo conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

OH – Occupational Health and 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 Health and Safety Management Systems Lead Auditor.

While ISO 45001 is used as the model for teaching audit, this class enables students to develop and apply auditing skills using any recognized management system standard.
A prior review of the ISO 45001:2018 standard and internal audit experience is suggested for this course.

____________________________________________________

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 ISO 14001 EMS Certified Lead Auditor - $1995
+

ENVIRONMENTAL MANAGEMENT SYSTEMS LEAD AUDITOR
WITH ISO 14001

Iso-14001-environmental-management-systems

We teach you how to use auditing to improve your organization

 Days: 4 • Price: $1995

Monday-Friday

Each 4-day class covers:

  • Environmental Management and Sustainability
  • Understanding and Reducing Environmental Impacts
  • Comparison of EMS Standards
  • Assessing Environmental Impacts
  • EMS Policy, Objectives and Targets
  • Audit Planning and Preparation
  • Environmental Legislation and Regulation (USA)
  • Documenting the EMS
  • Performing and Reporting the Audit
  • Environmental Education and Training
  • Corrective Action and Follow-up
  • Monitoring, Reporting and Improving Environmental Performance
  • Registration, Accreditation and Auditor Certification

The Workshops include:

  • Assessing Environmental Impacts
  • Environmental Policy
  • Objectives and Targets
  • Writing a Checklist
  • Opening Meeting
  • Audit Investigation
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Attendees successfully completing the examinations provided inExemplarGlobalLogo conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

EM – Environmental 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 an Environmental Management Systems Lead Auditor.

While ISO 14001 is used as the model for teaching audit, this class enables students to develop and apply auditing skills using any recognized 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.

4-Day ISO 13485:2016 Lead Auditor with 21 CFR 820 - $2095 Recognized by Exemplar Global
+

Quality Medical Device Management Systems Lead Auditor with ISO 13485:2016 and FDA 21 CFR 820

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Interpretation of the latest revision ISO 13485
  • FDA 21 CFR 820
  • 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 Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units:

MD – Medical Device 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 Medical Device Management Systems Lead Auditor.

Even though ISO 9001 and ISO 13485 are 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.

____________________________________________________

Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

3-Day ISO 9001:2015 Internal Auditor Course - $1595 Recognized by Exemplar Global
+

3-Day ISO 9001:2015 Internal Auditor

ISO 9001:2015 Quality Management Systems Lead 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 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.

3-Day Internal Auditor ISO 13485 Course - $1595 Recognized by Exemplar Global
+

Quality Medical Device Management Systems Internal Auditor with ISO 13485:2016

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 • Price: $1595

Monday-Thursday  8:00 am – 6:00 pm

    Each 3-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Interpretation of the latest revision ISO 13485
  • FDA 21 CFR 820
  • 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

    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


Axeon is an Exemplar Global Training Provider.

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units:

MD – Medical Device Management Systems
AU – Auditing Management Systems

The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Internal Auditor.

Even though ISO 9001 and ISO 13485 are 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.  Successfully completing the course examinations satisfies the training requirements for certification by Exemplar Global as an internal auditor.

3-Day IATF 16949:2016 and ISO 9001:2015 Internal Auditor $1595
+

3 Day IATF 16949:2016 AND ISO 9001:2015
Internal Auditor Class

 

Days: 3

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

Day 2 7:30 a.m.- 4:30 p.m.

Day 3 7:30 a.m.- 4:30 p.m.

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.

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 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

________________________________________________________________

3- Day AS9100 Rev D & ISO 9001 Internal Auditor- $1595
+

3 Day AS9100:2016 Rev D & ISO 9001 Internal Auditor Class

With Live Audits

Days: 3 • CEU Hrs: 2.4

Time: Day 1 7:30 a.m.- 4:30 p.m.

Day 2 7:30 a.m.- 4:30 p.m.

Day 3 7:30 a.m.- 4:30 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.

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

 

 

3 Day MDSAP & ISO 13485 Internal Auditor Class- $1895
+

MDSAP & ISO 13485 Internal Auditor Class with ISO 13485:2016

MDSAP-ISO-13485-certified-auditor-training

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 • Price: $1595

Monday-Thursday  8:00 am – 6:00 pm

Days: 3 • CEU Hrs: 2.4

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 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 Internal Audit 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.

2-Day Root Cause Corrective Action and Preventive Action Course- $1295
+

2-Day Root Cause Analysis, Corrective Action and Preventive Action Training

 

Schedule

Day 1: 7:30 am – 4:30 pm

Day 2: 7:30 am – 4:30 pm

Root Cause & CAPA 

This course teaches attendees 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.

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 an in depth understanding of the 8-step approach for CAPA’s.

 

Agenda

 

Day 1

  • Overview of Root Cause & Corrective/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
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement

 

Day 2

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

  • 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

 

Review & Exam

 

2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295
+

2-Day Risk Based Thinking and Risk Management

ISO 31000 & 14971

Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016

 Quality Risk Management Principles and Practices

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 Aerospace and Medical Device Manufacturers, these same techniques 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 and ISO 31000
  • 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.

 

What you will learn

  • The components of risk management that can be applied to any organization, regardless of their products or customers
  • How to design a risk management structure for your organization that gets results
  • 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
  • Tools used for Risk Assessment such as FMEA and FMECA
  • How to quantify risk as the first step in establishing priorities for your organization

 

Day 1 Agenda

  • Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
  • 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
  • Additional Requirements for ISO 31000

 

Day 2 Agenda

  • Guidelines from ISO 14971/31000 Risk Assessment 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

 

2-Day ISO 14001 Project Management Transition-Implementation
+

Understanding and Implementing ISO 14001

 

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 One

  • 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 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 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.

________________________________________________________________

2-Day ISO 13485 Internal Auditor- $1295
+

2-Day ISO 13485 Internal Auditor

Days: 2 • CEU Hrs: 1.9

Day 1: 7:30 a.m.- 5:30 p.m.

Day 2: 7:30 a.m.- 4:00 p.m.

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 ISO 13485 Quality Management Systems.

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 ISO 13485 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 13485 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 life-time professionals. 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
  • Fully understand and interpret the ISO 13485 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 13485

  • Demystifying the ISO 13485 standard
  • Interpreting and cross-referencing the quality standard
  • Analyzing audit findings
  • Audit exercises for application of ISO 13485 to quality events
  • 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

 

2-Day Human Factors - $1295
+

Human Factors – $1295

Days: 2 • 

 Day 1-2: 7:30 a.m.–4:30 p.m.

 

Course Description

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 course 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 will all of Axeon’s courses, this is a practical, how-to course 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?

Quality Managers, Managment Representatives, Quality Engineers, Safety Managers,  and Top Management

ALSO:   Quality Consultants, Those involved in performing corrective actions, Those involved in medical device risk management, and Regulatory Affairs Specialists

 

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.

 

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.

 

 

Course Syllabus

DAY ONE

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 TWO

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

 

 _______________________________________________________________

2-day EU MDR - $1295
+

European Medical Device Regulation

(EU MDR)

The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges. Strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.

The EU MDR isn’t in effect until May 2020. Companies with limited resources and sizeable medical device portfolios often need help planning how and when to transition MDR.

The two-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, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.

 

Agenda:

  • Overview of the Medical Device Regulation
  • Implementation timeline
  • Paths to CE Mark
  • Regulation structure overview
  • 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

2-day AS9100 Rev D & ISO 9001 Internal Auditor- $1295
+

 2 Day (18 Hr) AS9100:2016 Rev D & ISO 9001 Internal Auditor Class

Live online or Onsite Only

Days: 2 • CEU Hrs: 1.9

Time: Day 1 7:30 a.m.- 5:30 p.m.

Day 2 7:30 a.m.- 4:00 p.m.

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 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 AS9100:2016 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.

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.

Course 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

Part 1:  Introductions and Self-Assessment

  1. Course requirements
  2. How to get the most from this experience
  3. Networking with class mates (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 AS9100:2016, 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 AS9100:2016

  1. Demystifying the AS9100:2016 standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100:2016 to quality events
  5. Exercise #3-#7: Short case studies in quality events

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

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 for Certificate

 

2- Hour Introduction to Root Cause Corrective/Preventive Action Tools- Training Video $500
+

2- Hour Introduction to Root Cause Corrective/Preventive Action Tools- Training Video

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

2 Day ISO 9001:2015 Internal Auditor- $1295
+

2 Day ISO 9001:2015 Internal Auditor

Days: 2 • CEU Hrs: 1.9

Day 1: 7:30 a.m.- 5:30 p.m.

Day 2: 7:30 a.m.- 4:00 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.

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 ISO 9001:2008 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

 

1/2-Day Counterfeit Parts Class- $500
+

1/2-Day Counterfeit Parts AS5553 Class

We teach you how to identify and prevent the use of counterfeit parts

Days: 1/2 • Price: $500

Course 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 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

Course 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 {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

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)

1-Day Transition for ISO 9001:2015, ISO 13485:2016, AS9100:2016 Course $950
+

9001:2015 , 13485:2016, & AS9100:2016 Transition

Who Should Attend

Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100.

Course Objectives

  • Understand the key changes to ISO 901:2015, AS9100 Rev D (2016), and ISO 13485:2016
  • Understand the development and implications of Annex SL
  • Learn how the new format and structure of 2015 sub-clauses compares to those of 2008
  • Provide tools, techniques and tips to address the new requirements for strategic planning, risk management, the context of the organization, etc.
  • Become aware of new requirements in documentation

Agenda

 

Day One

 

  • New Requirements of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
  • Implications of Appendix 4
  • Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
  • Risk-based Elements of 6.1, 7.5.1, and 8.1
  • Action Plan Elements of 6.2
  • Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015 and AS9100:2016
  • Individualized Transition Road Map

 

1-Day NADCAP Basics- $850
+

 

1 Day Nadcap Introduction

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.

Course 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.

 

 

 

1-Day Maximizing the ROI from your Quality Management System- $950
+

Maximizing the ROI from your Quality Management System

1-day Managment Training

Days: 1

Schedule: 7:30-4:30 daily

Audience: Top management

Overview 

A 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.

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 are NOT the intended audience for this course, although they are certainly welcome.

 

Goals

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

 

Learning Outcomes

  • 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.

Couse Syllabus

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

______________________________________________________

1-Day ITAR & Export Basics- $850
+

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.

If your company is concerned about ITAR but you don’t understand US export regulations, then this training is for you.

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 once a month

4. Everything your company manufacturers or offers services on is either subject to the ITAR or EAR Regulations

5. 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

1-Day Food Safety Overview
+

1-Day Overview (Food Safety)

 

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 One

  • 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

 

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1-Day AS9102 First Article Inspection - $890
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AS9102 First Article Inspection

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 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.

An FAI is intended to:
•Reduce future escapes, risks, and total costs.
•Help ensure safety of flight.
•Improve quality, delivery, and customer satisfaction.
•Reduce costs and production delays associated with product nonconformances.
•Identify product realization processes that are not capable of producing a conforming product, and
•Initiate and/or validate corrective actions.

1-Day AS9100 Manager and Executive Overview
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AS9100 Overview

 

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