ISO17025 for In-House Calibration Labs: Is it required?

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dwperron

Trusted Information Resource
#12
As a guy living in the 17025 world with connections to 13485 and other such systems I can see what your auditor was looking for.

13485 requires that your calibrations be "against measurement standards traceable
to international or national measurement standards".

What is traceable? According to the VIM:
metrological traceability
property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty

Where 17025 comes into play here is that that traceability is required for 17025 accreditation, it can be assumed. That makes it easier on the auditor if you can just tell him "We are 17025 accredited". UL has the same sort of requirement, it makes their life easier.

If you are not able demonstrate measurement traceability through 17025 accreditation, you must then prove it on your own, by showing your measurement traceability - including uncertainties - all the way back to the national lab. It can be done, but it is a pain. It is also a pain for your auditor, as he is supposed to verify the traceability as part of 13485.
 
J

JoShmo

#13
As a guy living in the 17025 world with connections to 13485 and other such systems I can see what your auditor was looking for.

13485 requires that your calibrations be "against measurement standards traceable
to international or national measurement standards".

What is traceable? According to the VIM:
metrological traceability
property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty

Where 17025 comes into play here is that that traceability is required for 17025 accreditation, it can be assumed. That makes it easier on the auditor if you can just tell him "We are 17025 accredited". UL has the same sort of requirement, it makes their life easier.

If you are not able demonstrate measurement traceability through 17025 accreditation, you must then prove it on your own, by showing your measurement traceability - including uncertainties - all the way back to the national lab. It can be done, but it is a pain. It is also a pain for your auditor, as he is supposed to verify the traceability as part of 13485.
Which brings up an interesting point: Why does ISO/TS 16949 require regoister auditors (and internal auditos) to be specifically trained in MSA? Because most register auditors don't know what the above actiually means. They're happy to see a NIST number and that's all. They have no clue to ask if the company knws what to do with the expression of uncertainlty and how THAT affects the measurements being made...

If the client got the deer in the ehadlights look about being aksed about 17025, would that be "wrong"?
 

howste

Thaumaturge
Super Moderator
#14
Clealry, your auditor was a) wasting your time with chit chat or b) has only half a clue about the meaning of their question....

Don't waste your time any further with responding to this auditor. They won't know what to do with the answer, anyways...
I don't agree the auditor should have even braoched the subject.
...most register auditors don't know what the above actiually means....
:topic:

Sorry to take this off topic, but it sounds like you've had some bad experiences with certification body auditors. Admittedly there are some CB auditors out there that should have better knowledge and better auditing skills. However, I don't think it's wise or fair to project your bad experiences onto all CB auditors.

I believe we should stick to the facts and helpful advice, and leave the bad-mouthing out of the discussion.
 
J

JoShmo

#15
:topic:

Sorry to take this off topic, but it sounds like you've had some bad experiences with certification body auditors. Admittedly there are some CB auditors out there that should have better knowledge and better auditing skills. However, I don't think it's wise or fair to project your bad experiences onto all CB auditors.

I believe we should stick to the facts and helpful advice, and leave the bad-mouthing out of the discussion.
Why, then, does TS REQUIRE that calibration activites are understood by not only CB but internal audtors? Also, why are lab accreditation auditors needed to be competent in the lab scope? The reality is that it's not MY experience of auditors, but INDUSTRY which realized that the auditors HAVE to be competent in this science to know how to audit. You don't get taught that in any LA course! And we read here and in many other forums that a significant proportion of people ALSO don't get it - auditors ask for all kinds of things to be done which have zero to do with effective calibration. Not my bad experience at all. Simply pointing out that comments which may come from an unqualified source need to be treated with caution... My experiences isn't less valid that yours siply because you don't agree.
 

BradM

Staff member
Admin
#16
Hello JoShmo! Welcome to the Cove!

Why, then, does TS REQUIRE that calibration activites are understood by not only CB but internal audtors? Also, why are lab accreditation auditors needed to be competent in the lab scope? The reality is that it's not MY experience of auditors, but INDUSTRY which realized that the auditors HAVE to be competent in this science to know how to audit. You don't get taught that in any LA course! And we read here and in many other forums that a significant proportion of people ALSO don't get it - auditors ask for all kinds of things to be done which have zero to do with effective calibration. Not my bad experience at all. Simply pointing out that comments which may come from an unqualified source need to be treated with caution... My experiences isn't less valid that yours simply because you don't agree.
This site thrives from people adding/sharing their own experiences; especially in the field of auditing. There are many instances, and many here (who are auditors) which we would agree with your passion about poor auditing/auditors. I have always respected the auditors here because they are some of the most passionate with respect to bad auditors and poor auditing. They represent their trade with Pride, and thus, get very :mad: when they feel individuals have become victims of poor auditors.

The question posed by the original poster is about the auditor simply asking a question. That's all. And many of the responses that you made, appear to me that because of the one question, you feel the auditor (and auditors as a whole) are incompetent. Is that not a reasonable assumption?

So people are going to challenge that assumption, because they feel it's an over-generalization. That is not saying your opinion is worthless; rather, they just don't agree. And as we know... we all don't have to agree on everything.

We appreciate having new faces with new opinions and perspectives here. And that includes yours. But when anyone (myself included) post something of a feeling opinion that can be construed as over-generalized and maybe painting with a broad brush, they should expect to be challenged.
 
#17
What sort of audit was this? Do you get visited by this auditor?
Sorry for the late response fellas, as the auditor was hitting all of our sites, including today.

Yes, we were visited by this auditor on site. In my experience with auditors, a lot of times they may ask this type of question to see how it's answered (i.e. do they know what ISO17025 is). I like simple answers, and in this case, my answer was no, but others are involved and they wanted to add additional verbiage including in my DOP.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#18
Sorry for the late response fellas, as the auditor was hitting all of our sites, including today.

Yes, we were visited by this auditor on site. In my experience with auditors, a lot of times they may ask this type of question to see how it's answered (i.e. do they know what ISO17025 is). I like simple answers, and in this case, my answer was no, but others are involved and they wanted to add additional verbiage including in my DOP.
Oh, okay. I wondered because it's disturbing to think someone was having you do this via questionnaire.

I have often asked about the controls used when clients do their calibrations internally, but I don't expect 17025 because that specification is mostly for labs who perform calibration services as a business. The degree of risk and the required sensitivity based on tolerances and/or industry can raise requirements (e.g. automotive, to TS 16949) but most places I have worked with don't have such needs. My antennae go up when I think I hear of auditors who seem to expect more out of people than is needed.
 
S

shethprati

#19
I had a similar question: We are using a external vendor lab who performs dimensional inspection for us or I would say First Article Inspection? Do they need to be ISO 17025 accredited?
 

dwperron

Trusted Information Resource
#20
Where I come from this can be a sticky question.
The AB I work with covers Dimensional Testing and Dimensional Calibration. These are separate, but sometimes equal. The question that needs to be asked is "is the device being inspected / tested / calibrated used in the traceability of your measurements?" If it is then they need 17025 accreditation.

Here's an example. Suppose you send a gage out for "inspection". If you are using this as a master, setting up reference measurements based on it, then your measurement traceability goes through it and it needs to be 17025. If you use it for quick Go / NoGo testing your measurements are not traceable through it, it does not need to be 17025. Traceability is the key item here.
 
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