ISO 13485 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

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

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

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

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

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

Prerequisites

There are no required prerequisites for this training.

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

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

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

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

Who Should Attend

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

 

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider.

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

Exemplar Global TPECS Certified badge for ISO 9001 Lead Auditor

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

 

ISO 13485 Lead Auditor Training Objectives 

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

 

Agenda

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

 


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