Audit & Agreements for "Test Laboratory" Supplier?

ga2qa23

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#1
Hi all, when you contract a "Test Laboratory" supplier to write test protocols and perform controlled testing to meet standard(s), do you perform audits of them (either in-person or remotely) as part of your supplier evaluation/qualification procedure?

Do you also sign a formal Supplier Quality/Regulatory Agreement with them? Or do you instead just get a Quote document from the Test Laboratory, then you provide a Purchase Order, which acts as the contract for performing testing services to meet the standard(s).

I myself am part of a medical device startup and we're getting quotes from various test laboratories to perform our "design verification" testing on our medical device prototype for things like biocompatibility validation, cleaning validation, sterilization validation, etc. We feel that at a minimum, a remote audit is required, to confirm that they have calibrated equipment, training, etc. But we feel that you wouldn't normally sign a Supplier Quality/Regulatory Agreement for performing lab testing like this.
 
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ECHO

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#2
When I was at a bigger company, we made sure the "Test Laboratory" stayed up to date on their ISO 13485 cert. I can't remember if we enforced this with a SQA.

When I was at a start up, we used UL, because they have a blurb in their protocol and report about ISO 13485 cert. I am not sure if they still do. Before you send them the PO, just make sure they still add it.
 

ECHO

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#4
For the start up, we definitely didn't.

For the bigger company, if we did, the design quality and engineering team wasn't involved. That said, we probably had some kind of SQA because we were only allowed to use the 1 testing house.
 
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