Guest user Created: Nov 12, 2019 Last commented: Nov 13, 2019

Transition to ISO 13485:2016

We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?

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Kristina Zvonar Brkić Nov 13, 2019

First of all, you need to get a new edition of ISO 13485: 2016 and do a GAP analysis for the new requirements. You can find the difference between the new and the previous edition of the standard in Annex A of the standard ISO 13485:2016 - Comparison of content between ISO 13485: 2003 and ISO 13485: 2016.

For more information and details, I suggest a meeting which you can schedule here: https://advisera.com/13485academy/free-consultation/

Of course, fell free to see if our ISO 13485:2016 toolkit can help you on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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Nov 12, 2019

Nov 13, 2019

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