Acceptable use of a non accredited external ISO/IEC 17025 laboratory

L

Lisa Cooper

#1
#1
Hello everyone: My organization was recently recommmended for certification to ISO/TS16949. One of the minor nonconformances was for using a nonaccredited external for calibration services. The lab's initial ISO/TS16949 certification assessment is scheduled for Sept 2004 - not too big of issue. This finding has lead to a internal disscussion around when can we use a non accredited ISO/IEC 17025 lab. Can you use a non accredited external lab for chemical or material characterization testing if the test is strictly for engineering purposes such as ascertaining initial material characterization or problem analysis data? It seems to me if the data is not used for process development, pre-launch or process/product validation or verification it may be acceptable.

Thanks for you input.
 
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C

cncmarine

#2
#2
Question:

Why would you need to use a non accreited lab?
Are you responsible for the design?
 
S

SteelWoman

#3
#3
See 7.6.3.2 - it says if you use an outside lab they MUST:

A) Have a lab scope (even the non-certified ones have this document, in my experience)

AND must EITHER:

B) Be certified to a nationally recognized lab standard

OR

C) You must have evidence that your customer approves their use.


We developed a form letter that we send to our automotive customers (we only have Tier 2 automotive customers) whenever we are faced with using a non-certified entity and inform them of the name of the company, the service they will provide, and what their certification status is - as long as the customer signs it and approves their use (I've NEVER had a customer NOT sign off on it) then we're good to go, as long as I also get that Lab Scope from them. We've been audited on this several times and the auditor has not had a problem with it at all - how can they? It's pretty clear in 7.6.3.2.

The question of why WOULD you use an uncertified body? It happens - we recently sold a large portion of our facility to a competitor - including the Technical lab. The lab was covered by our TS certification, but now is NOT certified to anything under the new owner. The new owners are also our MAJOR supplier of steel, so we have no real choice but to use them. Enter the customer approval letters. We also have another processor/sub (not a lab, but same concept) that is LITERALLY housed in a barn - a tiny slit operation that just happens to be next to one of our customers and they're very comfortable using them and WANT us to use them to sub the work. But even with them we had to get it in writing from the customer.

Hope that helps. Remember that in MOST instances, customer approval/request trumps the standard.
 
Last edited by a moderator:
L

Lisa Cooper

#4
#4
Thank you for the replies.

First to respond to the "Question: Why would you need to use a non accreited lab? Are you responsible for the design?"

One of the analytical labs we occasionally use for material characterization is not accredited, nor plans to be accredited. We provide small income and volume to this rather largely profitable specialized lab with many non-automotive suppliers, extremely large semiconductor customers base. Therefore, we have no leverage and they see no incentive or value in achieving this accreditation.

I fully understand and agree with "SteelWomen", however I was hoping to find there is exceptions for applying this requirement depending on the type of testing performed. So apparently as I suspected, it's all external lab regardless of testing purpose.

Our TS auditor started down the path of establishing a criteria for when external labs must comply, but he was reluctant and eluded to the fact I need to understand the purpose of the test and how the data was used. Leading me to believe there is some defined line. However, I didn't want to open up Pandora’s box during the audit.

I'm happy to accept any other thoughts on this topic.

Best Regards,

Lisa
 
G

Gayle215

#5
#5
17025 lab accreditation

Hello there,
If anyone can provide feedback on this issue it would really help a great deal. At our Corporate headquarters we have an internal lab of sorts, I'm told by some that the testing done is for R&D purposes and by others that the information is submitted to the customer.
Then we have sister companies that each have their own internal labs, some have decided to become accredited others have not.
Then we have a sister company that does only testing which is sometimes used by one of the other plants.

I'm clear on the internal labs need to conform but, I'm not totally clear on the Corporate lab or the offsite lab.

If a sister company uses the corporate or offsite lab, is this considered an external lab which must be accredited or given acceptance by the final customer?
 
Hershal

Hershal

Metrologist-Auditor
Trusted Information Resource
#6
#6
Gayle215,

Technically, the Corporate lab has a supplier-client relationship with the sister organization. Therefore, the sister organization needs to define whether accreditation is required. This is also true for the off-site lab, when they do work for another group.

I certainly suggest it is beneficial, and in some arenas is a requirement, but the sister organization may be operating in a market where it is optional.

Should accreditation be necessary, there are a number of accrediting bodies in the U.S. that can perform accreditation to ISO/IEC 17025. They include IAS, A2LA, NVLAP, L-A-B, ACLASS and others. SCC (Canada) is also accepted in the U.S.

If you need accreditation to ISO Guide 65, then only ANSI or SCC are available in the U.S. currently.

Hershal
 
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