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Integration ISO 13485 & ISO 9001

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Guest user Created:   May 11, 2021 Last commented:   May 12, 2021

Integration ISO 13485 & ISO 9001

I have already purchased the toolkit of ISO 13485 + MDR and
I noticed that in the Procedures there are references to ISO 9001.

But I don't see an ISO 9001 + ISO 13485 integrated toolkit on your website,

so if I want to get the ISO 9001 toolkit,

should I still keep it separate from ISO 13485?

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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 May 12, 2021

No, we do not have integrated ISO 9001 and ISO 13485. It is not necessary to have both standards. ISO 13485 is a quality management standard specially made for medical device manufacturers. Some manufacturers also have ISO 9001, so we left ISO 9001 in References for them. 

If you want to get ISO 9001 toolkit, you do not maybe need to buy the whole toolkit, only some documents according to which ISO 9001 differs from ISO 13485.

Here you can find an article regarding similarities and differences between ISO 9001 and ISO1 3485:

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May 11, 2021

May 12, 2021