Must you use an ISO 17025 lab in order to receive ISO 9001:2000 Certification

J

JkelleyCDS

#1
I have worked at two previous employers, both ISO 9001:2000 certified, and they have always used a calibration service who only had an ISO 9001:2000 certification, not ISO 17025. They have always passed their audits without a problem.

My question is, can I get my ISO 9001:2000 certification at my new employer by using a calibration service not certified to ISO 17025? My Pre-Assessment audit was this week and the auditor indicated that I must use an lab with ISO 17025 certification.

Thanks for your feedback.
 
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DannyK

Trusted Information Resource
#2
There is no requirement in ISO 9001 that a calibration lab has to be certified to ISO 17025.

The calibration lab has to provide a report which shows traceability to national standards.

Ask the auditor where in the ISO 9001:2000 standard it specifies ISO 17025 as a requirement for calibration labs.
 

SteelMaiden

Super Moderator
Super Moderator
#3
Or, ask your auditor which standard he is auditing you to.:notme: There isn't even a requirement that says you have to use a lab to do your calibrations. If you had the means to do everything yourself you could. (most of us wouldn't want to or wouldn't have the resources, tho.)
 
J

JkelleyCDS

#4
Thank you guys. There were some questionable things this guy said, that I did not agree with.

I was thinking the same thing. The calibration company I am using does have standards traceable to NIST which is what matters.

Thank you for the sanity check!:thanx:
 
#6
No! It doesn't say so, anyone can read the standard and see that! The auditor is either smoking something, or maybe they're trying to tell you something, but it came out wrong.........or maybe they're stuck with a paradigm from TS audits......
 
J

Jeff Frost

#7
The auditor should only be auditing to the requirements of ISO 9001:2000 Clause 7.6 unless one of your customers has specified in their PO a quality requirements that you must use a lab that is ISO 17025 compliant/registered for the calibration of monitoring and measuring devices.

If you accepted PO’s with this requirement as as part of your contract review process (Clause 7.2) an exception was not taken to this requirement by your organization the auditor does have a justified finding of nonconformity because you are not meeting the customers contract requirement to use calibration labs meeting the requirements of ISO 17025.

We sometime forget that the ISO 9001:2000 requires us to meet the requirements of the Standard, those requirements imposed by our customer through their contracts and any regulatory requirements for the product we are producing. Each of these can result in a finding of nonconformity during an audit.
 
J

JkelleyCDS

#8
I'd hate to say but I thought this auditor was playing good cop/ bad cop sometimes. Very strange but he had some good insight.

He was just really hard to figure out when he stated that our company required this or that... i.e. ISO 17025.

I responded firmly a few times and put him check because once he got going (on a power trip of sorts) it just snowballed until I would say something.
 

SteelMaiden

Super Moderator
Super Moderator
#9
Jeff, you have a valid point but one would hope that if an auditor found something in a PO requiring a 17025 lab, he would point out where the requirement came from, not just say that you have to have a 17025 lab do your cals.
 
J

Jeff Frost

#10
That is true but it sometimes is amazing how 2nd party auditors write up findings of nonconformity.
 
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