Guest user Created: Apr 09, 2020 Last commented: Apr 10, 2020

ISO 13485 Implementation

If I have a certificate of ISO13485 (for my 1st factory) , and now i would like to expand my business to second factory , can i add a new facilities information on the available ISO ? or i have to apply a new ISO13485?

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Kristina Zvonar Brkić Apr 10, 2020

You can add a new facility to the existing ISO 13485 certificate if the processes on the new facility are covered by the scope of your ISO 13485 certificate. In that case, just inform your certification body that during the next audit you want to make a Scope extension to the new facility.

For more information, read this article:

What are the steps for ISO 13485 certification? https://advisera.com/13485academy/blog/2020/03/18/iso-13485-certification/

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Apr 09, 2020

Apr 10, 2020

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