ISO 17025 Nonconformance or Not? Chemical Testing Laboratory - Need Help

M

McAuliffe0317

#1
A chemical testing laboratory has listed on its A2LA Scope of Accreditation, several methods for ICP-MS. The method has validated standard detection limits for all of these methods. However, they also have, in the same written SOP, low level and ultra low level detection limits. The low level and ultra low level detection limits are not validated.
The laboratory uses an "ISO 17025" and a "non-ISO" report format for its results. The ISO 17025 report format does NOT contain the use of the A2LA symbol or make any reference to accreditation, but it does contain all elements, as required by the ISO 17025:2005 standard, including the method number. This method number directly corresponds to the same method number on their Scope of Accreditation.

I initially wrote a nonconformance on an internal audit. My nonconformance was that:

"The low level detection limit is not included in the method validation performed on mmddyy (document #xxx). There is no exception noted on the final report that this level of detection is not covered under the current ISO 17025 Scope of Accreditation."
My thought being that a client, who pulls the Scope of Accreditation while looking at their test report (which states the method number) would incorrectly assume it was covered under the Accreditation.

Does everyone agree that this is a nonconformance? If so, what clause of the standard? Also, what would be a good corrective action? We have considered separating the low level detection limit methods from the standard level detection limits methods and also have considered a "deviation" on the final report. Any thoughts? Now, I am having second thoughts. The laboratory has been accredited for several years and has gone through three different assessors. This has not been noted as a problem in any audit.

Thanks for any help!
 
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BradM

Staff member
Admin
#2
Re: ISO 17025 Nonconformance or Not? Need Help

The laboratory uses an "ISO 17025" and a "non-ISO" report format for its results. The ISO 17025 report format does NOT contain the use of the A2LA symbol or make any reference to accreditation, but it does contain all elements, as required by the ISO 17025:2005 standard, including the method number. This method number directly corresponds to the same method number on their Scope of Accreditation.


Hello there!:bigwave:

A quick question. Notice I bolded/underline a part of your quotation. Did you mean to say the non-ISO report does not contain the symbol or make reference? I would think it would be on the ISO 17025 report.
 
#3
Re: ISO 17025 Nonconformance or Not? Need Help

What type of audit are you performing? Internal? Accreditation or Supplier?

If you are not certain of the requirements of ISO/IEC 17025, then I'm not sure you have a non-conformity! Also, if this is an internal audit, what does the lab's own documentation - rather than the standard - have to say about this?

You might not find sufficient clarity in the standard's reqirements to make anything really 'stick'....
 
M

McAuliffe0317

#4
Re: ISO 17025 Nonconformance or Not? Need Help

This is an internal audit. Regardless of the type of audit, the lab still must meet the requirements and intent of the standard. Whether one "knows" the standard, or not, there still can be a nonconformance. The internal procedures should be in compliance with the standard.

The laboratory is a chemical testing laboratory. They do not put the A2LA symbol on their test reports. Never have since they received accreditation.

The laboratory procedures do not address "combined" methods in which there may be two different levels of detection.

I would appreciate an outsider's view on the interpretation of the ISO 17025 standard. Does this lab need to differentiate the standard and low level test methods, either on the report or with separate method numbers? Thanks
 
#5
Re: ISO 17025 Nonconformance or Not? Need Help

Now I'm confused by your statements....

Is this lab accredited? You mention A2LA and then say the lab isn't accredited....

Are they providing results from testing and required to do this, by the client, within their accredited scope? If the test method is outside the accredited scope, did they inform the client?

Since the lab procedures don't address such 'combined' methods, that's where your problem really lies, I believe. It would be in appropriate to ignore that in any type of audit.....

I feel as if we need more info.
 

Jim Wynne

Staff member
Admin
#6
Re: ISO 17025 Nonconformance or Not? Need Help

Is this lab accredited? You mention A2LA and then say the lab isn't accredited....
The OP doesn't say the lab is not accredited. He says "They do not put the A2LA symbol on their test reports. Never have since they received accreditation. " (my emphasis)


Are they providing results from testing and required to do this, by the client, within their accredited scope? If the test method is outside the accredited scope, did they inform the client?
They don't inform the client, which is the conundrum the OP is concerned with. They do testing that's outside the scope, but don't divulge that fact on the reports.

I think the OP is right to be concerned, as it appears that a customer may assume that the testing is within the accredited scope. That doesn't mean it's an NC, though, unless the customer is being deliberately deceived. The first thing a lab customer should do is review the lab's scope and determine whether the testing they want falls within it. If the lab represents non-accredited test procedures as being accredited, there's a problem.
 
#7
Re: ISO 17025 Nonconformance or Not? Need Help

I didn't read it that way Jim, since there's a comma missing.........

On the other issues, I'll await the OP's comments back rather than get out my crystal ball.......
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Re: ISO 17025 Nonconformance or Not? Need Help

Technically no, it is not a non-conformance under the Standard. The internal QMS may have additional documentation that makes it so however. Also, review the A2LA policies regarding use of the logo to see if they require it.

Test labs, even if they are accredited, at least in the U.S., are NOT required to issue a report with the logo, even if the report otherwise complies with Clause 5.10, it is left as a business decision.

Hope this helps.
 
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