ISO 13485:2016 Auditor Transition

Course Description

For Existing Auditors. This 1-day workshop is intended to provide an understanding of the ISO 13485:2016 changes and how to audit to the new requirements.


Trained ISO 13485:2003 (EN ISO 13485:2012) Auditors who are looking to upgrade to audit to ISO 13485:2016 requirements and individuals responsible for the oversight of ISO 13485 compliance.

Course Objectives

Upon completion of the course the participants will be able to:

  • Understand the detailed requirements of ISO 13485:2016
  • Have the ability audit to ISO 13485:2016 requirements
  • Understand the relationship between ISO 13485 and other regulatory standards
  • Understand how the relationship between ISO 9001 and ISO 13485 has broken
  • Envision the impact the changes will have on the organization

What the Attendees Walk Away With:

  • Comprehensive ISO 13485:2016 workbook
  • ISO 13485:2016 Audit Checklist
  • ISO 13485:2016 Auditor Certificate

1 Day

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Outline:

Overview of ISO 13485 Quality Management System Standard
Class Objectives
History of ISO 13485 and its relation to ISO 9001:2015
ISO 13485 Quality Management Systems Terms and Vocabulary
Information on transitioning from ISO 13485:2003 to ISO 13485:2016

Interpreting the differences between ISO 13485:2003 & ISO 13485:2016
Element by Element Review Including:

  • Changes to each Element
  • What to look for during an audit
  • Who is audited
  • Role Plays

Presentation of Final Exam