CONTACT US twitter facebook

ISO 13485 Lead Auditor

Course Description

This training course is designed for those individuals who are responsible for Auditing a Medical Devices Quality Management System (MDQMS) in accordance with the requirements of ISO 19011.

After completion, you will be have a detailed understanding of audit techniques and competency requirements of Audit team leads, allowing you to manage an audit programme, audit team, communicate with customers, and manage conflict resolution.

On Day 4 of the course, you can sit for the exam. If you pass, you gain the “Certified ISO 13485 Lead Auditor” Certificate which demonstrates that you have the capabilities and competencies to audit organizations MDQMS.

Target Audience

  • Senior Auditors seeking to perform and lead MDQMS certification audits 
  • Managers aiming to understand the requirements of the audit process
  • Individuals responsible for identifying and making available the evidence required of a MDQMS Audit
  • Team members preparing for a MDQMS audit

Learning Outcomes

  • Understand the requirements of a MDQMS
  • Understand the similarities between ISO 13485 and other standards
  • Understand the role of an Audit team lead
  • Learn how to manage an Audit team
  • Learn how to define an ISO 13485 scope and develop an Audit plan
  • Acquire the skills of a lead Auditor in planning an audit, conducting an audit, drafting reports, and follow-up activities

Our approach

  • Training is based on ISO 19011 best practice  
  • Modules are illustrated with real world examples
  • Exam questions are based on a case study
  • Practice quizzes are similar to the Certification Exam questions


An understanding of ISO 13485 and knowledge of ISO 19011.

Course Overview

  • Module 1 Foundational principles and concepts of a MDQMS
  • Module 2 MDQMS Scope 
  • Module 3 Audit concepts and principles 
  • Module 4 Planning of an ISO 13485 audit 
  • Module 5 Delivering an ISO 13485 audit 
  • Module 6 Closing an ISO 13485 audit 
  • Module 7 Managing an ISO 13485 audit programme

Course Agenda

  • Day 1:  Medical Devices Quality Management Systems (MDQMS) and ISO 13485
  • Day 2: ISO 19011 Audit principles
  • Day 3: Day 1 & Day 2 Audit activities 
  • Day 4: Closing the audit, reporting and follow-up activities, and the Certification exam


  • All candidates at official training courses are tested throughout their course with quizzes and exercises, in combination with a final exam held on the last day of the course.  Both elements are a part of the overall score. For this course, the final exam constitutes a 12 question essay type exam which should be completed within 180 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store.
  • Exam results are returned within 24 hours, with successful candidates receiving both a digital badge and a Certificate of Achievement
download pdf