ASL requirement when the supplier is certified for ISO 13485

akp060

Involved In Discussions
#1
Hi All,

Someone told me that you don't require to list a supplier who is compliant with ISO 13485 and certified for that matter. I would like to request some opinions here, as there no such interpretation from the standard
 
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shimonv

Trusted Information Resource
#2
You need to control the lis of your suppliers and there is really no exception. Having an ISO 13485 does not mean that you are immune from errors.
 

John Broomfield

Staff member
Super Moderator
#3
Your supplier selection and re-selection criteria have to be effective.

Blaming a certification scheme is not going to be accepted by any competent auditor, let alone your customers.
 
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