Do Supplier's Laboratories Need to be Accredited to ISO/IEC 17025

[dlsquality]

Hello All!

We currently use test results from a supplier that is included in our qualification report (i.e. validation). Although the standard doesn't specifically state this, is there an implied requirement for supplier's laboratories to be accredited to ISO/IEC 17025? Does the fact that we use their data as part of our validation process emphasize this need?

Looking forward to your feedback and opinion!

Daniel

 

[Boscoeee]

Hello All!

We currently use test results from a supplier that is included in our qualification report (i.e. validation). Although the standard doesn't specifically state this, is there an implied requirement for supplier's laboratories to be accredited to ISO/IEC 17025? Does the fact that we use their data as part of our validation process emphasize this need?

Looking forward to your feedback and opinion!

Daniel

What standard is your QMS under?

 

[Stijloor]

Hello All!

We currently use test results from a supplier that is included in our qualification report (i.e. validation). Although the standard doesn't specifically state this, is there an implied requirement for supplier's laboratories to be accredited to ISO/IEC 17025? Does the fact that we use their data as part of our validation process emphasize this need?

Looking forward to your feedback and opinion!

Daniel

Daniel.

The supplier's lab is considered an external laboratory and must be accredited.

Stijloor.

 

[dlsquality]

We are accredited to ISO/TS 16949

 

[dlsquality]

So are you implying that all of your suppliers that provide data (e.g. acceptance data) have ISO/IEC 17025 accredited laboratories?

 

[db]

Daniel.

The supplier's lab is considered an external laboratory and must be accredited.

Stijloor.

I'm not sure I agree with this as a blanket statement. It sounds like they way they use the data, it does need to be. However, this got me thinking. TS does not require the organization’s internal lab to be accredited. However, if my company buys product from my supplier, who’s lab doesn’t have to be accredited for their TS, is that lab considered an external lab to me? I would tend to think not (otherwise, all tier 2 and below would need to have their labs accredited).

I think I would need a little bit more information on the relationship of the two companies to make a judgment.

And also, don’t forget that external labs may be used without accreditation, if there is evidence that the lab is acceptable to the customer.

 

[dlsquality]

If you read the definition of a laboratory in the ISO/TS 16949 standard, it's defined as a facility for inspection... Doesn't that imply that inspection and/or test is their main activity?

 

[db]

If you read the definition of a laboratory in the ISO/TS 16949 standard, it's defined as a facility for inspection... Doesn't that imply that inspection and/or test is their main activity?

Short answer is no. That is why they have requirments for internal labs. So, if I have a calibration lab in my facility, it has to meet the requirements.

I am unclear as to your relationship with the supplier. Is the data they are sending you related to the parts they ship you, or are they using a third party to test stuff for you (which is kinda how I read it). If they are doing testing for you, then they need to meet the requirments of the external lab.

 

[dlsquality]

The supplier does assembly work for us and performs acceptance tests on the assembled parts.

 

[db]

The supplier does assembly work for us and performs acceptance tests on the assembled parts.

Okay, in that case, I would say that they would not have to be accredited. However..... they still have to be acceptable to your customer (as would any supplier). If they are TS, then you might want to have a copy of their lab scope to ensure their internal lab is capable.