ASL requirement when the supplier is certified for ISO 13485

[akp060]

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

 

[shimonv]

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]

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.

 

[akp060]

Thank You @shimonv

 

[akp060]

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.

Agreed. The ASL has to be there

 

[John Broomfield]

Agreed. The ASL has to be there

An approved supplier list is not a requirement of the standard.

But having and using effective supplier selection criteria is.

 

[akp060]

An approved supplier list is not a requirement of the standard.

But having and using effective supplier selection criteria is.

Noted, Thank You for the clarification