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Using ISO 9001 documents for ISO 13485

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Guest user Created:   Jul 15, 2022 Last commented:   Jul 18, 2022

Using ISO 9001 documents for ISO 13485

I am currently working through the ISO 13485 documentation, and have noticed that some of the documentation is similar to the ISO 9001 documentation.  If applicable, could I use some of the templates / documents that we have for ISO 9001 for 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 Jul 18, 2022

Yes, you can. This applies mostly to, for example, forms and procedures for internal audit, corrective measures, and non-compliant products.  

On the following link you can find the article that compares ISO 9001 and ISO 13485:

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