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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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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.
On the following links you can find some useful articles:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Sep 10, 2020
Sep 11, 2020
Sep 11, 2020