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Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers - Page 5

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  Post Number #33  
Old 30th September 2016, 10:32 AM

Total Posts: 771
Re: Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers

"It is the responsibility of the manufacturer to determine which are critical items or processes and how their purchase is controlled. This depends on the manufacturer’s risk management activity. However, the auditing organization may decide to visit suppliers deemed by the manufacturer to be non-critical."
So it is up to you to decide - but your NB may disagree with you.

Your NB obviously knows about any suppliers listed on your certification and in this case I would suggest that the agreement you have with such a supplier would need to explicitly state the need for support for audits (both announced and unannounced).

Your other suppliers will be subject to your "Supplier Evaluation" process, which will be examined as part of any routine NB audit. It is at this stage where the NB may decide that your control over a particular supplier is not robust enough, so this identifies other suppliers with which you may need formal audit agreements in place. (Though, as Somashekar suggests, it is probably good practice to have that in place for all supply agreements).
Thanks to Pads38 for your informative Post and/or Attachment!

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