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ISO 13485:2016 Transition Overview

Course Details:

1 Day, 6.5 Instructional Hours
6.5 Engineering Professional Development Hours (PDHs)

Course Description:
Learn what you need to know to transition to the new ISO 13485:2016 Quality Management System (QMS) standard in this one-day overview.

Prerequisites: Understanding of ISO 13485:2003 is required.

Learning Objectives:
This course will provide participants an understanding of the key changes and how they will impact their organization. Our experienced instructor will discuss the new requirements, facilitate hands-on exercises, and provide guidance on how to transition to ISO 13485:2016. Upon completion of this course, you will be able to:

  • Explain the reason for the changes to ISO 13485:2016
  • Explain the requirements, and purpose of ISO 13485:2016
  • Identify and understand the key changes between ISO 13485:2003 and ISO 13485:2016
  • Explain how regulatory requirements have been imbedded into ISO 13485:2016
  • Identify the gaps between ISO 13485:2016 and your current QMS
  • Assess the overall impact the new requirements will have on your current quality management system
  • Contribute to the development of a transition plan to ISO 13485:2016
  • Determine key strategies and actions to ensure an effective transition
  • Understand the transition timeline

Each participant will receive a training manual and a copy of the ISO 13485:2016 standard.

Who Should Attend:
Participants finding this course beneficial include those in organizations that are currently certified to ISO 13485:2003 and looking to transition to ISO 13485:2016. In addition, this course would be essential to:

  • Senior management responsible for the effectiveness of the QMS
  • Employees assisting organizations with their transition to ISO 13485:2016
  • Management representatives, operations managers, process owners, and consultants responsible for ensuring the requirements are met

Course Info


For location details and single session sign-ups:



Claire Pickrell

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