Address of Legal Manufacturing Site in ISO 13485 certificates?

N

N.Abue

Registered
#1
#1
Hello,

So our company has 2 legal entities. The companies address is in Belgium however our legal manufacturing facility is in another country. Our ISO 13485 certificate is under the Belgian address. Do we need to get a new ISO certificate with the legal manufacturing address or does the ISO certificate still apply?

Thanks
 
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shimonv

shimonv

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#2
#2
Usually each site has its own QMS certificate, unless you have multi-sites QMS certificate, that is two or more sites that operate under one QMS system.
 
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