Are ISO 9001 certified companies required to use ISO17025 facilities for calibration?

al40

Quite Involved in Discussions
#1
We're ISO certified and the calibration service I use is ISO 17025 compliant and meets the DOD requirements as well. I plan on doing on-site audit of their facility and I have also reviewed shared audits from two other companies that have done audits there as well.

My main question is this an violation of ISO 7.6 if we don't use a ISO 17025 registered company??


Thanks,:confused:

Al
 
Elsmar Forum Sponsor
#2
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

We could do with a bit more info....

Is the lab accredited to 17025? Or are they claiming compliance?

You don't specifiy which 'ISO' you're certified to. Also, what's your 'scope'? If, for example, you make test/inspection products and have it calibrated by an external lab, then that would be import. If you are 'ISO/TS' 16949, then it matters, for compliance.

If you make non-test/inspection products, then it's not a case of compliance, but good business practice. You will be able to rely on the lab for good results if they are accredited. If not, caveat emptor.......

BTW, if they are accredited, why are you going to audit them? If they aren't, what are you going to audit them against (criteria??)

Andy
 

Jim Wynne

Staff member
Admin
#3
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

Allen M. said:
We're ISO certified and the calibration service I use is ISO 17025 compliant and meets the DOD requirements as well. I plan on doing on-site audit of their facility and I have also reviewed shared audits from two other companies that have done audits there as well.

My main question is this an violation of ISO 7.6 if we don't use a ISO 17025 registered company??
There is no such requirement. (BTW, labs, including calibration facilities, are accredited to 17025 or another national standard, not registered.)
Whether or not it's prudent to use a non-accredited lab is another question. Just out of curiousity, if you already know that the lab is "ISO 17025 compliant," why do you need to audit them?
 

Jim Wynne

Staff member
Admin
#4
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

AndyN said:
We could do with a bit more info....

You don't specifiy which 'ISO' you're certified to. Also, what's your 'scope'? If, for example, you make test/inspection products and have it calibrated by an external lab, then that would be import. If you are 'ISO/TS' 16949, then it matters, for compliance.
If it's ISO 9001, there is no requirement, regardless of what the OP's company makes or has calibrated by an outside source. Calibration labs are treated as are other suppliers. In the case of 16949 (7.6.3.2), use of a non-accredited source is permissible when "...the external laboratory is acceptable to the customer..." when there is evidence that the lab "...meets the intent of ISO/IEC 17025 or national equivalent."

AndyN said:
If you make non-test/inspection products, then it's not a case of compliance, but good business practice.
I agree wrt "good business practice."

AndyN said:
You will be able to rely on the lab for good results if they are accredited. If not, caveat emptor.......
No, you'll be able to rely on them being accredited. There is a better chance of efficacious practices, perhaps, but not to the extent of blind reliance on accreditation. All sorts of wacky things have been done in accredited labs.
 

RoxaneB

Super Moderator
Super Moderator
#5
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

Not a requirement as long as your own system doesn't deem it as being one. You determine what you need/want/require.

Ironically enough, for outside calibration activities, we were receiving worse service from the accredited versus the non-accredited (but that's a whole separate topic). ;)
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

As others have posted, it depends on your certification.....if 9K, you can (being a bit facietious here) have the high school auto body shop do your calibration, document reasonably well, and you are OK.....

If you are an accredited test lab then you must use an accredited cal lab if available.

For others Standards, I will let other folks answer.

As Andyn correctly points out, if they are accredited to ANS/ISO/IEC 17025 by a recognized AB, why audit them? Get the cert and scope and verify they can support your equipment under their scope, and you should be done.

Hope this helps.

Hershal
 

al40

Quite Involved in Discussions
#7
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

Hershal said:
As others have posted, it depends on your certification.....if 9K, you can (being a bit facietious here) have the high school auto body shop do your calibration, document reasonably well, and you are OK.....

If you are an accredited test lab then you must use an accredited cal lab if available.

For others Standards, I will let other folks answer.

As Andyn correctly points out, if they are accredited to ANS/ISO/IEC 17025 by a recognized AB, why audit them? Get the cert and scope and verify they can support your equipment under their scope, and you should be done.

Hope this helps.

Hershal

Thanks,

for the input.
 

al40

Quite Involved in Discussions
#8
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

Jim Wynne said:
There is no such requirement. (BTW, labs, including calibration facilities, are accredited to 17025 or another national standard, not registered.)
Whether or not it's prudent to use a non-accredited lab is another question. Just out of curiousity, if you already know that the lab is "ISO 17025 compliant," why do you need to audit them?

I don't I have "Shared" audits from other companies that have done compliance audits in the past.


Thanks,

Al
 
Q

QADave

#9
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

We are an ISO 9001:2000 Certified company. A manufacturer of screw machine parts, as well as CNC 6 axis, e.t.c.
We are a 2nd tier supplier to an automotive company, and the U. S. Military.
Our business is not strictly automotive, we have varying customers and applications.
During a recent audit, external, there was a QSIR stating that the calibration certification for 3 of our pieces of equipment, were no good because they did not state "ISO 17025".
It was written as "Measuring equipment shall be calibrated against standards tracable to International or National measurement standards i.e. ISO 17025"
One certificate stated "Calibration in Accordance with the requirements of Mil Std 120, Mil Std 45662A, ASTM-E18 and manufacturer's procedures."
Is it a requirement that all calibration be done by a 17025 lab, if the standard of workmanship is acceptable to our company, and no evidence that any calibrations done by that company has affected the Quality system?
The "Objective Evidence" section stated that the certification had "no reference to a measurement standard."
If the standards listed, Mil Std 120, Mil Std 45662A, and ASTM-E18 are not acceptable, then how can the calibration company state that, if the standard is outdated, has been replaced, or is not acceptable for an audit?
Example: ISO IEC Guide 25 ,which has been replaced.
We have been certified for several years now, using this same company, and this issue has never risen before.
Thanks for any help given.
QADave
 
C

Craig H.

#10
Re: Are ISO certified companies required to use ISO17025 facilities for calibration?

QADave said:
It was written as "Measuring equipment shall be calibrated against standards tracable to International or National measurement standards i.e. ISO 17025"
DAve, I have big problems with they way this was written up. Tracability refers to the physical standard used. A weight, for instance, could be compared to a weight that was compared to a different weight that was compared to a different weight (etc.) that was compared to the master NIST weight. It could have been done (or not) by an ISO 17025 lab.

We are not ISO 17025, but if you ask me real nice I might let you borrow our 1 KG test weight that is tracable to NIST, and I have the paperwork to prove it. This should satisfy the requirements.

BTW, the only time I have had a problem that came close to the discussion in this thread I had an instrument that was calibrated, and the cert. paperwork said that the calibration company was ISO 17025 accredited. Sure enough they were, but the instrument in question was not in the scope of the accredation, and the auditor had apparently had some experience with the company (not a good experience I would guess). A nonconformance resulted. A supplier firing resulted from that.

The issue was not whether or not they had 17025, it was that they said that they did, on the paperwork, and were not "qualified" for the particular instrument.
 
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