Quality Agreements with external testing laboratories now mandatory?

rajanala83

Registered
So an auditor from our Notified Body told us that the laboratories we contact to do raw material and final product testing doing for product release are to be considered critical suppliers by us, and that we need to draw up quality agreements with them including the usual clauses, including e.g. access for the Notified Body to do unannounced audits. Note that all laboratores are ISO 17025 accredited with the respective national authority.

This is a new requirement apparently and our head of QM thinks this is overreach, and not all of the labs are terribly keen on signing our agremeents, obviously. As we are a smaller player in the market we cannot nudge them to do so and there just aren't that many alternatives.

I 'm just wondering if this is something others also have heard from their Notified Body and am happy to hear everyones thoughts and advice on the matter.
 

Billy Milly

Quite Involved in Discussions
I would agree with the auditor - you outsource your production control to those labs and (probably) release your product based on their results. Do you do any product/material testing (same or different?) besides the outsourced?
 

rajanala83

Registered
THank you for your answer!

We do some internal testing also, but the external testing is key to confirm the composition / safety of the raw material - we don't have the capability (machines etc) to do this in s. Also the microbiological status testing of the final product - doesn't make sense to do it in house. So we do release based on their results.

But would national accreditation not be enough - I mean if accreditation is valuable and the lab is accredited, shouldn't we be able to trust them, their methods, and their results?
 

Sidney Vianna

Post Responsibly
Leader
Admin
But would national accreditation not be enough - I mean if accreditation is valuable and the lab is accredited, shouldn't we be able to trust them, their methods, and their results?
If that rationale was valid, an accredited certification for other critical suppliers such as contract manufacturers and sterilization houses would replace such agreements. There is a reason for 13485 to invoke the establishment of such service agreements with critical suppliers.
 

rajanala83

Registered
Thank you! That is also a point well worth considering. I will review our supplier qualification procedure to see if the SOP reflects this.

Now I wonder if quality agreements with external laboratories are common industry prectice in the EU...
 

PFILE

Registered
I've had a similar experience with quality agreements being required for all suppliers that are considered an outsourced process. It's a requirement in ISO 13485:2016, clause 4.1.5.
 

d_addams

Involved In Discussions
The Quality Agreement doesn't explicitly have to cover elements governing the validity of their test results. Think of it more of an agreement about how the two companies will operate and partner together. Types of things you'll see in the quality agreement:
- The supplier WILL MAINTAIN accreditation to 13485.
- The supplier will maintain a CAPA system to identify and correct non-conformances.
- The purchaser maintains accountability for final product release, not the supplier.
- Change notification requirements.
 

rajanala83

Registered
The Quality Agreement doesn't explicitly have to cover elements governing the validity of their test results. Think of it more of an agreement about how the two companies will operate and partner together. Types of things you'll see in the quality agreement:
- The supplier WILL MAINTAIN accreditation to 13485.
- The supplier will maintain a CAPA system to identify and correct non-conformances.
- The purchaser maintains accountability for final product release, not the supplier.
- Change notification requirements.


Thank you! Do you include granting access for conducting unannounced audits (to the Notified Body) and access to SOP for the methods used in quality agreements with suppliers, especially laboratories?
 

d_addams

Involved In Discussions
Thank you! Do you include granting access for conducting unannounced audits (to the Notified Body) and access to SOP for the methods used in quality agreements with suppliers, especially laboratories?

I'm not super familiar with labs specifically and how often an on-site inspection would be asked for test house supplier but if that is a potential need then it should be stipulated (either it is or is not allowed) in the Quality Agreement. Same thing with SOPs. Sometimes suppliers will not share work instructions or methods with you for confidentiality/IP reasons, but in those cases the information could be confidentially shared directly with the Regulator rather than through the client if it needs to be shared with the Regulator. Not sure I've seen suppliers not willing to share policy's/procedures.
 
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