Quality Agreements with external testing laboratories now mandatory?

[dwperron]

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.

If you are dealing with a 17025 accredited lab, then this is all covered in 7.1 Review of requests, tenders, and contracts.
This is where you will discuss and agree upon any specific requirements you have for the lab, including your quality agreements.
More specific is section 7.1.7:
The laboratory shall cooperate with customers or their representatives in clarifying the
customer's request and in monitoring the laboratory’s performance in relation to the work performed.

 

[Chrisx]

ISO 13485 clause 4.1.5 states that a supplier that affects product conformity to requirements must have a written quality agreement. However, does a testing laboratory affect the products ability to conform to requirements? I don't think it does. If I understand the scenario correctly, the test lab is not performing any activity on the product. There test does not change anything about the products conformity to requirements. Rather, the test lab detects whether the product conforms to requirements. That is not the same thing.

 

[Sidney Vianna]

ISO 13485 clause 4.1.5 states that a supplier that affects product conformity to requirements must have a written quality agreement. However, does a testing laboratory affect the products ability to conform to requirements? I don't think it does. If I understand the scenario correctly, the test lab is not performing any activity on the product. There test does not change anything about the products conformity to requirements. Rather, the test lab detects whether the product conforms to requirements. That is not the same thing.

So, a lab that is responsible for final product acceptance and testing does not affect product conformity? What if the lab wrongfully accepts nonconforming products and releases it to the market? The fact that the lab might fail the conformity assessment verification implies that it does and clearly affect the product conformity status in my view.

 

[EmiliaBedelia]

The original question is in the EU regulations forum and mentions critical suppliers, so I think ISO 13485 is not even fully relevant here. Yes, a supplier who is basically performing final inspection is a critical supplier per the EU definition. A critical supplier is defined as a supplier of a product or service where "failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause a significant degradation in performance", which final inspection certainly is. MDD and MDR both required that the NB shall carry out audits/assessments on a supplier if critical activities are being outsourced.

ISO 13485 clause 4.1.5 states that a supplier that affects product conformity to requirements must have a written quality agreement. However, does a testing laboratory affect the products ability to conform to requirements? I don't think it does. If I understand the scenario correctly, the test lab is not performing any activity on the product. There test does not change anything about the products conformity to requirements. Rather, the test lab detects whether the product conforms to requirements. That is not the same thing.

Agreed with Sidney Vianna that this argument does not hold water. Final inspection definitely impacts the conformity of products in the field.
4.1.5 also states that "controls shall be proportionate to the risk involved" - final inspection is perhaps the most important step in the entire process, so the risk here is high, thus additional controls should be imposed.

There are also a lot of requirements from ISO 13485 related to product inspection, control of nonconforming product, etc that are not necessarily covered by ISO 17025. Even if the lab is accredited to this standard, the manufacturer needs to ensure that they are meeting the requirements of ISO 13485 - if they don't hold accreditation to that standard, it's probably most straightforward to document through a QA. From both the EU and ISO 13485 perspective, I think there is a clear need for a QA in this situation.

 

[Chrisx]

I'm not sure how the quality agreement is going to prevent laboratories making errors. The quality agreement could require ISO 17025. Maybe it would reduce the risk. However, if I already require labs to be ISO 17025 certified as part of the supplier approval criteria, then it won't make much difference.

Many test laboratories are not certified to ISO 13485. It may be difficult to identify ISO 13485 certified laboratories that can perform the necessary tests.

My only point was that there is not a clear requirement in ISO 13485 that a quality agreement is required for testing laboratories. I didn't mean to imply that their activities do not pose risks. There are significant risks with test laboratories, but they do not directly affect conformity to requirements.

 

[Sidney Vianna]

but they do not directly affect conformity to requirements.

We all know and agree that one cannot inspect nor test quality into the product; however, inspection and testing DOES affect the product conformity status and that cannot be denied.

 

[EmiliaBedelia]

I'm not sure how the quality agreement is going to prevent laboratories making errors. The quality agreement could require ISO 17025. Maybe it would reduce the risk. However, if I already require labs to be ISO 17025 certified as part of the supplier approval criteria, then it won't make much difference.

Many test laboratories are not certified to ISO 13485. It may be difficult to identify ISO 13485 certified laboratories that can perform the necessary tests.

My only point was that there is not a clear requirement in ISO 13485 that a quality agreement is required for testing laboratories. I didn't mean to imply that their activities do not pose risks. There are significant risks with test laboratories, but they do not directly affect conformity to requirements.

ISO 13485 does not specifically call out any type of supplier (sterilizer, packager, manufacturer, lab...) as requiring a quality agreement. The requirement is tied only to the risk level of the activity being performed. You are expected to use and interpret the standard with respect to your company's specific situation - there COULD be a situation where a test lab is not performing a high risk activity, so the standard does not require a QA across the board. If you agree that there is a higher risk involved with a test laboratory in this specific situation, this then means that you need to implement greater controls, which shall include QAs.

If your laboratory is not ISO 13485 certified and they are performing activities that are within the scope you will need to demonstrate that they are meeting all of the requirements prescribed by the standard for that particular activity. Certification, either to ISO 13485 or to ISO 17025 could be a "shortcut" to demonstrating supplier competence but it's not the only way.