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ISO 9001:2015 Quality Management

Axeon is an Exemplar Global Certified Training Provider. 

ISO 9001 Quality Management Systems, the world’s leading quality management standard, has recently been revised.

What is ISO 9001?

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

Why was ISO 9001 revised?

All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.

What are the main changes to the standard?

The new version follows a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk.

I am certified to ISO 9001:2008. What does this mean for me?

Organizations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.


Early Bird Pricing

• $200 off- 90 Days in Advance

• $100 off- 60 Days in Advance


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

Monday-Thursday  7:30 am – 5:30 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 Certified Training Provider.

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

QM – Quality Management Systems
AU – Auditing Management Systems
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.

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 Certified Training Provider.

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

QM – Quality Management Systems

AU – Auditing Management Systems

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

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

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



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


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



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 Risk Management: AS13004 PFMEA Training - $1295

2- Day Risk Management

AS13004 PFMEA Training

This is Risk Management for the Aerospace and ISO 9001.

This class teaches participants a well-organized, systematic approach to Risk Assessment that targets and reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Aerospace and ISO 9001 Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

Who should attend

  • Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
  • Addresses requirements for ISO 9001 Risk-based Thinking, AS9100 Operational Risk Management, and
    AS13004 PFMEA and Control Plans.
  • Quality Managers
  • Management Representatives
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Project Teams

What you will learn

  • How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
  • How to address the Operational Risk Management requirements of AS9100 (per AS13004).
  • Tools used for Risk Assessment such as FMEA and PFMEA.
  • How risk management can be applied to any organization, regardless of its products or customers.
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed.
  • How to quantify risk as to the first step in establishing priorities for your organization.

Day 1 Agenda

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

Day 2 Agenda

  • Guidelines for performing Failure Modes and Effects (FMEA) analysis
  • Detailed hands-on case study developing an FMEA analysis, with tools for completing each stage.
  • Requirements for Operational Risk Management.
  • Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans.
  • Guidance on using AS13004 methodology to meet Operational Risk Management requirements.

2 Day ISO 9001:2015 Internal Auditor- $1295

2 Day ISO 9001:2015 Internal Auditor

Days: 2 • CEU Hrs: 1.9

 7:30 a.m.- 5:30 p.m.

Audience: Beginner to Advanced



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.


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.




 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 How to Perform Remote (Virtual) Audits $500

The emergence of COVID-19 and its related worldwide travel restrictions, combined with the need to conduct quality, supplier, and/or regulatory audits, has required organizations to find alternatives to the traditional face-to-face audit that can be implemented now.

If you will be participating in a virtual audit, as the auditor or auditee, you need this class. It doesn’t matter which side of the table you will be sitting on.


This is a practical, how-to course that is not bogged down in academic discussions. It focuses on applying ISO guidelines for remote auditing, along with techniques for conducting audits using computer-based and telecommunication tools.

An excellent add-on to an internal- or lead-auditor training course!

• Understand the differences between in-person and remote auditing.
• Help you identify risks and opportunities posed by remote auditing.
• Learn tips and methods for effectively performing a remote audit.

Who Should Attend?
• quality managers • internal auditors
• audit program managers • quality consultants
• lead auditors


This training does not include full internal- or lead- auditor training. (That would be a prerequisite for this class for the Standard to be audited.)

Training Agenda
1 Feasibility of Remote Auditing
2 Tips for Remote Auditing
3 Confidentiality, Security & Data Protection
4 Risk Assessment for Remote Auditing
5 Planning a Remote Audit
6 Conducting a Remote Audit
7 Limitations of Remote Auditing


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



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 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


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.



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 AS9102 First Article Inspection - $890

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.