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

Ronen E

Just a person
Super Moderator
#31
Re: NB Audits of Sub-Contractors and Critical Suppliers

How then, do I determine what suppliers need to have contracts that allow for unannounced audits if the NB has the authority to visit a supplier that I have not identified as critical?[/LEFT]
I believe that the following clause from the MEDDEV is key:

Whether the subcontractor is undertaking the supply of a part, material or service, which may affect the compliance of the device with the essential requirements.
Cheers,
Ronen.

PS At the end of the day it is a matter of risk management. If you estimate that the odds of the NB deciding to audit a supplier - due to lack of controls on your part, quality consistency issues or else - are low, you may decide that the risk is low enough (acceptable) and skip the audit-access provisions in the contract. If you do so, however, I recommend that those odds are estimated in a formal, documented process that represents top management support.
 

somashekar

Staff member
Super Moderator
#32
Re: NB Audits of Sub-Contractors and Critical Suppliers

How then, do I determine what suppliers need to have contracts that allow for unannounced audits if the NB has the authority to visit a supplier that I have not identified as critical?
Its a good manufacturing practice to establish contracts across your subcontracting suppliers. Its also a good practice to include about audit agreements by self or second party, at any point of time with reasonable prior information, without infringement on the suppliers other processes that are not connected. You may never audit most of your subcontracting suppliers per your discretion, but that is an other matter.
 
#33
"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).
 

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