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Difference (implementation-wise) between ISO 13485 and ISO 9001

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Guest user Created:   Sep 10, 2020 Last commented:   Sep 11, 2020

Difference (implementation-wise) between ISO 13485 and ISO 9001

What is the difference (implementation-wise) between ISO 13485 and ISO 9001, can the two QMS run together?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 11, 2020

There is no difference in the implementation process between ISO 9001 and ISO 13485. Those two standards can run together. However, since ISO 13485:2016 does not have a high level structure as ISO 9001:2015 does, you just need to take into consideration the numbering of the requirements. At the end of the ISO 13485:2016, in Annex B you can find Correspondence between ISO 13485:2016 and ISO 9001:2015. 

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Sep 10, 2020

Sep 11, 2020