Guest user Created: Nov 16, 2023 Last commented: Nov 16, 2023

Identifying gaps between ISO 13485 and ISO 9001

We are currently ISO 13485 certified. We would like to become ISO 9001 certified. Do you have anything that will help me identify the gaps that we need to fill?

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Kristina Zvonar Brkić Nov 16, 2023

We do not have as part of our documentation toolkit any GAP analysis template. But you can look at this article for details:

Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

Also, you can check the Annexes in ISO 13485:2016, where you have a cross-reference table between ISO 9001:2015 and ISO 13485:2016.

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Nov 16, 2023

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