ISO 13485:2016 Transition

The new ISO 13485:2016 standard is published in March 2016. To inform you about the changes within the new standard, we developed a training course in which these changes are explained.

With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll be able to identify the gaps in your current Quality Management System (QMS).

Who should attend?

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

You should have good knowledge of ISO 13485.

What will I learn?

You will learn about:

  • Key changes
  • How these changes may impact your current QMS
  • 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 and ISO 13485:2016 and identify how these may impact your organization
  • Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
  • Make a smooth transition to ISO 13485:2016 and understand what resources may be required

What's included?

  • 3 hours training course (09 am - 1 pm)
  • English spoken and English training material
  • Including training material and lunches

* This training is also offerend in combination with the Changes for Internal Auditor training session in the afternoon. If you are interested in this training, click here.

This training is also available in Dutch.



We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 80 or send an email to