How the ISO 9001:2015 Revision Affects Medical Device Companies

How the ISO 9001-2015 Revision Affects Medical Device Companies

The ISO 9001:2015 is set to be the most far-reaching change brought about to the ISO 9000 series standards since 2000. The most discernible change that medical device companies have to adopt is that they will now be taking a process management approach rather than a checklist approach for inspecting the final product.

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