Critical Supplier/Quality Agreement Procedure

Al Rosen

Staff member
Super Moderator
#1
Does anyone have an example of a procedure for determining a critical supplier and an example of a Quality Agreement that would be used for different types of Critical Suppliers.

I would think a Quality Agreement for a component supplier would be different than a supplier of services or for an Authorized Representative.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Regarding the quality agreement, yes, it's different from suppliers and third parties.

Suppliers basically have to do their own thing, and you decide if the product they supply fulfill your requirements (this relationship is treated by 7.4 of ISO 13485).

Third parties (as in 4.1.5 of ISO 13485) are in fact acting on behalf of the organization, including doing things in the name/under the responsibility of the organization to fulfill applicable regulatory requirements. So the quality agreement has to focus on responsibilities and activities related to this compliance. Unfortunately, the only good guidance that exists right now for this in the document Contract Manufacturing Arrangements for Drugs: Quality Agreements , which is for pharma, but the generic guidance fits for devices too.
 
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Al Rosen

Staff member
Super Moderator
#3
Thanks, Marcelo. I'd still like to see some examples of the procedure and agreements or templates, if anyone has something they can share without revealing sensitive information.
 
#5
Thanks, Marcelo. I'd still like to see some examples of the procedure and agreements or templates, if anyone has something they can share without revealing sensitive information.
i was working on QAg inhouse, and does some level of internet search before formalizing ours;

enclosing certain ref...just in case if you haven;t already seen these...
there are others., which i will add in next post.,
 

Attachments

#8
You can use the same general template for service and component suppliers. Just make some tweaks based on what is supplied. But the general structure is the same.
 

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