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Question about notify body

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Guest user Created:   Dec 16, 2021 Last commented:   Dec 17, 2021

Question about notify body

I am putting an ISO 13485 QMS system.  I have previously had 2 QMS systems in other companies accredited by notified bodies and thought that this is the only way to gain certification. My present line Manager states other companies other than notified bodies can issue ISO 13485 instead of going down the notified body route, I am not sure that this is right. I cannot find a company that does this. Am I right in thinking it has to be a notified body
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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 Dec 17, 2021

If you want to have proper certificate, that will be recognized worldwide, it has to be a certification body.

For more information on this topic, please see following article:

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