View Full Version : Do Supplier's Laboratories Need to be Accredited to ISO/IEC 17025
dlsquality 16th July 2008, 03:44 PM 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 16th July 2008, 03:50 PM 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 16th July 2008, 03:53 PM 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 16th July 2008, 04:04 PM We are accredited to ISO/TS 16949
dlsquality 16th July 2008, 04:05 PM So are you implying that all of your suppliers that provide data (e.g. acceptance data) have ISO/IEC 17025 accredited laboratories?
db 16th July 2008, 04:09 PM 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 16th July 2008, 04:13 PM 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 16th July 2008, 04:18 PM 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 16th July 2008, 04:21 PM The supplier does assembly work for us and performs acceptance tests on the assembled parts.
db 16th July 2008, 04:29 PM 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.
Stijloor 16th July 2008, 04:32 PM The supplier does assembly work for us and performs acceptance tests on the assembled parts.
It seems that we're dealing with an outsourced process.....
Do you require PPAPs from that supplier?
Now, assuming for a moment that they could be considered an "internal lab", have you verified the "defined scope?" (Re: 7.6.3.1)
Does your customer require PPAPs from you, and if so, does the submittal include your supplier's testing results/data?
Great topic...:agree1:
Stijloor.
db 16th July 2008, 04:42 PM It seems that we're dealing with an outsourced process.....
Interesting point. I was looking at them as a supplier (providing product), but now...
Daniel, do you buy product from this other company, or do they assemble your product and test it? It could make a difference.
Do you require PPAPs from that supplier?
I did not even go there, but TS does require you to apply the product approval process to your suppliers. So, I would assume that you do require PPAPs (or equivalent).
bobdoering 16th July 2008, 05:48 PM Daniel.
The supplier's lab is considered an external laboratory and must be accredited.
Stijloor.
Actually, the TS16949 standard offers two options in 7.6.3.2, and one of them is to be accredited. The other is to show evidence of acceptability to the customer. Often, if the vendors are TS16949, and the testing falls within the laboratory scope of their certification, it will work. ISO vendors can be a little dicier. Most customers demand that for PPAP a third party lab be used, but for ongoing control the internal lab may suffice. But, better get it in writing (evidence). :cool:
dlsquality 16th July 2008, 05:54 PM This particular supplier is certified to ISO/TS 16949
bobdoering 16th July 2008, 06:08 PM This particular supplier is certified to ISO/TS 16949
I would ask them for a copy of their lab scope from their quality manual or TS cert. If they have one - and it covers the type of testing they are doing, you are golden. If not, you may want to ask your customer SQE (sooner than later). Better safe than sorry.
prototyper 17th July 2008, 05:05 AM The supplier does assembly work for us and performs acceptance tests on the assembled parts.
Can you be more specific on the type of acceptance tests performed?
If these tests are to validate their processes then I don't believe ISO/IEC 17025 is required. (TS16949:2002 7.6.3.1)
If these tests are to validate work done by either you or one of your other sub suppliers then they become a third party laboratory and ISO/IEC 17025 is required. (TS16949:2002 7.6.3.2)
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