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Why would a non-medical dev manufacturer want to implement QMS using 13485?

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Guest user Created:   Jul 28, 2020 Last commented:   Jul 29, 2020

Why would a non-medical dev manufacturer want to implement QMS using 13485?

Hi, I’m looking for some guidance with quality manual and quality policy, can you help?
ISO 13485 is for medical device manufacturers- why would a non-medical dev manufacturer want to implement QMS using 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 29, 2020

If you are looking for guidance for Quality Policy and Quality Manual, but you are not a manufacturer of medical devices, then you should look for the ISO 9001. ISO 9001:2015 is a standard that is applicable to all businesses.

Following articles can help you to understand the ISO 9001:2015:

You can even look at our Quality manual template and Quality Policy template from our ISO 9001:2015 Documentation toolkit:

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Jul 28, 2020

Jul 29, 2020