ISO 13485:2016 Transition

Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard.

With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.

By attending, you’ll be able to identify the gaps in your current Quality Management System (QMS) and start planning your transition and certification to comply with ISO 13485:2016.

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.


Who should attend?

  • Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.

What will I learn?

You will learn about:

  • Key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016
  • Revised terms and definitions
  • Relationship between ISO 9001:2015 high level structure and ISO 13485:2016
  • Transition timelines and what resources may be required.

How will I benefit?

This course will help you:

  • Recognize the key changes between ISO 13485:2003/EN 13485:2012
  • Understand how these changes may impact your current QMS
  • Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
  • Consider transition timelines and what resources may be required.

What is included?

  • You will gain 8 CPD hours
  • Training course notes
  • Lunch
  • Refreshments
  • An internationally recognized BSI Training Academy certificate 
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    For availability and any further information, please contact our training department at Tel: 3149 3326