What are the Scope Numbers on ISO 13485 Certificates

chris1price

Trusted Information Resource
#1
Hi

I was reading the small print on the ISO13485 certificate for a supplier, and it said "Scope numbers 14, 19".

Looking elsewhere, I saw "Main Activity Field EA/IAF 14, 19"

I can't think of anywhere in 13485 that uses these numbers and I have not noticed this before on other certificates. Can someone enlighten me as to what they mean?

Thanks
Chris
 
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chris1price

Trusted Information Resource
#3
Re: Scope number in 13485 Certificate

Many thanks for the quick response.

No the supplier is not the certification body, they are moulding and assembling medical devices, so the scope looks correct.

I have not seen this previously on a certificate, I need to read the small print more often :)

Chris
 
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