ISO 13485 Lead Auditor Training (In-Person)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

 

Overview

Compliance with ISO 13485 and FDA regulations is critical for medical device manufacturers to ensure product quality, meet customer expectations, and maintain regulatory approval. A well-executed audit program is essential for identifying risks, improving processes, and demonstrating compliance. Skilled lead auditors play a crucial role in helping organizations uphold these standards and achieve long-term success.

This in-person ISO 13485 Lead Auditor Training course provides a structured, hands-on approach to auditing Medical Device Quality Management Systems (QMS). Recognized by Exemplar Global, this program equips participants with the knowledge and practical skills to conduct audits in alignment with ISO 13485:2016 and 21 CFR 820. Through real-world applications, you’ll learn how to interpret and apply the standard’s requirements within your organization.

Led by experienced instructors, this course covers every stage of the audit process, including:

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

This ISO 13485 Lead Auditor in-person training experience provides direct interaction with instructors and peers, fostering deeper discussions, immediate feedback, and a more immersive learning environment. Hands-on exercises, role-playing scenarios, and case studies reinforce key auditing techniques, ensuring you leave the course with practical, applicable skills.

By the end of the program, you’ll be prepared to conduct internal, supplier, and third-party audits with confidence, 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 looking at x-rays

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 ISO 13485 Lead Auditor Certification in Medical Device Quality Management Systems.

 

ISO 13485 Lead Auditor Training Objectives 

  1. Develop the knowledge and skills required to become an ISO 13485 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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