4-Day ISO 13485:2016 with FDA 21 CFR 820

Lead Auditor Training Course

Online-Virtual Classroom

4 Day Schedule: 7:30 AM – 5:30 PM MST


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

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


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

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

Who Should Attend?

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



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

Course Objectives

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


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