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Clean room not part of my certification

#1
I am 13485 Certified and I do not include our R&D clean room. I have an upcoming Recertification audit and i am running an R&D project in the clean room, do I have to add this to my certification as a change? I am not using this for production and I do not plan to.
 
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Cthames

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#2
As long as it is clear that the area is strictly for R&D, and that you aren't performing any production, validation, or verification activities within that room, you should be okay. I would make sure anyone approaching the room can tell it is strictly for R&D via signage. Perhaps add a statement in the scope of your QM that explains why you choose not to certify the other room?
 
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