Is ISO 13485 Location Specific?

D

dchella16

Hello,

I'm trying to understand if an ISO 13485 certification is location specific. For example, can my office in the US work under the QMS of our office in India?
 

John Broomfield

Leader
Super Moderator
Hello,

I'm trying to understand if an ISO 13485 certification is location specific. For example, can my office in the US work under the QMS of our office in India?

dchella,

Your US Office may work under your QMS if it applies both to India and the USA; you make this clear in the scope statement.

...but you’ll find that certification is location specific and the included locations are stated on each certificate.

You may ask your CB to extend your certificate for your India facility to include your US office but they’d have to audit the US office.

John
 
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