ISO 13485 & EU MDR / 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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We do not have as part of our documentation toolkit any GAP analysis template. But you can look at this article for details:
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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