ISO 9001 Requirements for ISO 17025 Accredited Calibration Laboratory

#1
I have written ANSI for their determination, but they have not replied and it's been several months. I am hoping someone here can help.
We had our ISO 9001:2008 Audit and the auditor informed us that we cannot use 3 of our calibration labs to calibrate some of our gages and equipment because they are not specifically ISO17025 accredited. They are accredited to other well known standards, just not ISO17025. We have used them through at least 4-5 other ISO audits and those auditors, all different, never found this to be a problem. I do not find anything stating that we can only use 17025 labs. Verbiage from ISO9001 doesn't state this specific requirement. We use the labs suggested by the manufacturers of the gages and equipment. We are supplied with valid calibration certificates. Does anyone have any information or experience with this? I'd really like to address this before our surveillance audit. Thanks.
 
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Sidney Vianna

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#2
Re: Accredited calibration labs-ISO 9001

Does anyone have any information or experience with this? I'd really like to address this before our surveillance audit. Thanks.
It is very simple: if an external auditor tells you that you can only outsource calibration services to an ISO 17025 accredited lab, the auditor MUST identify the source for the requirement. Failure to identify an applicable requirement invalidates the nonconformity. It is THAT simple.

A simple contact with a knowledgeable manager at the CB office would suffice to appeal of this nonconformity and void it.
 

Ajit Basrur

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#4
I have written ANSI for their determination, but they have not replied and it's been several months. I am hoping someone here can help.
We had our ISO 9001:2008 Audit and the auditor informed us that we cannot use 3 of our calibration labs to calibrate some of our gages and equipment because they are not specifically ISO17025 accredited. They are accredited to other well known standards, just not ISO17025. We have used them through at least 4-5 other ISO audits and those auditors, all different, never found this to be a problem. I do not find anything stating that we can only use 17025 labs. Verbiage from ISO9001 doesn't state this specific requirement. We use the labs suggested by the manufacturers of the gages and equipment. We are supplied with valid calibration certificates. Does anyone have any information or experience with this? I'd really like to address this before our surveillance audit. Thanks.
Not a direct answer to your question but I found this on the ANAB site - http://anab.org/news/latest-news/sh...ted-to-isoiec-17025-or-certified-to-iso-9001/

What if a Laboratory has ISO 9001 Certification?

Laboratories can be audited and certified to the international management systems standard ISO 9001, which is widely used in manufacturing and service organizations to evaluate their systems for managing the quality of their products and services.

While effective as a management evaluation tool, ISO 9001 is not appropriate for evaluating the technical competence of a supplier's laboratory. The evaluation of a supplier against ISO 9001 does not assure you or your customers that the test, inspection, or calibration data are accurate and reliable.
 

WCHorn

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#5
ISO 9001 does not require you to use ISO 17025 certified labs, but here's a warning. Make sure your own procedures do not impose the requirement. The auditor should have cited where the requirement comes from; make sure the auditor is not citing you for non-conformance to your own procedures before you bring this up with your CB.
 

Sidney Vianna

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#6
make sure the auditor is not citing you for non-conformance to your own procedures before you bring this up with your CB.
Yes. But, much more likely is the scenario that the auditor in question also audits against the ISO/TS 16949 which has a requirement along those lines, but is not paying attention that the audit in question is NOT against 16949, but 9001.

Some auditors who are qualified for multiple standards have a hard time focusing on audit criteria, sometimes.
 
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