Internal laboratories to be accredited to ISO 17025?

B

Bigfoot

#1
Hello all. I have recently been told second hand that there is a push being put on by the accreditation bodies for businesses with Internal Labs to become accredited to the 17025 standard.

I have worked extensively with the source of this information, (a 17025 accredited calibration & metrology lab), and consider them to be reliable.

Has anyone in the forums here heard anything to that effect?
 
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Helmut Jilling

Auditor / Consultant
#2
Bigfoot said:
Hello all. I have recently been told second hand that there is a push being put on by the accreditation bodies for businesses with Internal Labs to become accredited to the 17025 standard.

I have worked extensively with the source of this information, (a 17025 accredited calibration & metrology lab), and consider them to be reliable.

Has anyone in the forums here heard anything to that effect?
The TS standard states clearly (in 7.6.3.1 - Note) that it is not mandatory. ISO never had any such req. So, that would be an odd new approach.

Heck, it practically took an act of Congress just to get all the external labs accredited. They fought that for 5 years.
 

Miner

Forum Moderator
Staff member
Admin
#3
Bigfoot said:
Hello all. I have recently been told second hand that there is a push being put on by the accreditation bodies for businesses with Internal Labs to become accredited to the 17025 standard.

I have worked extensively with the source of this information, (a 17025 accredited calibration & metrology lab), and consider them to be reliable.

Has anyone in the forums here heard anything to that effect?
I have not heard that one either, and would view it with suspicion. Accreditation bodies do not create the need for accreditation to any standard, customers do, or you do it yourself for competitive advantage.
 
B

Bigfoot

#4
hjilling said:
The TS standard states clearly (in 7.6.3.1 - Note) that it is not mandatory. ISO never had any such req. So, that would be an odd new approach.

Heck, it practically took an act of Congress just to get all the external labs accredited. They fought that for 5 years.
I know that it is not a requirement of TS or ISO. The source that told me this info told me that the info came from the Lab accreditation group they use for 17025, and that this was being pushed down to the suppliers. What he did not say was who is pushing this. With the many experts we have participating in these forums, some of whom are external assessment auditors for 17025, someone could confirm this or refute it.
 
C

corollax

#5
My guess is that as ISO17025 is getting more popular, some regulatory bodies (eg. airworthiness authorities) may one day align their calibration requirements to ISO17025 and outsource this element to accreditation bodies. In other words, when complying with ISO17025 requirements is recognized as fulfilling the requirements of the regulatory body, this will in turn compel some companies to seek accreditation of their in-house cal lab.

At least this is what's happening in my country...
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
Bigfoot said:
With the many experts we have participating in these forums, some of whom are external assessment auditors for 17025, someone could confirm this or refute it.
OK, here I am.....

ABs do not create the markets, however if an internal lab is being used - depending on some variables - the controls on the internal lab may need to at the very least be strengthened to support accreditation. Often, a lab will find that intenal labs may have significant benefit from accreditation. This is typically the case where a large test lab is doing a lot of internal cal.....then a potential non-conformity under clause 5.6.2.1.1 is certainly avoided.

Yes, we encourage it, and there are occasions where we might write a CAR on an internal lab.....but we don't create the market. On the other hand.....count on an internal lab to get a lot more review. The organization I work for, if we see a lot of internal cal going, may well call upon me to visit the internal cal lab, in addition to any other assessment.

Why? ABs who are signatory to MRA (e.g IAS, A2LA, etc.) view accreditation as a serious responsibility on the part of both us and our accredited labs.

Hope this helps.....standing by for the flaming arrows.....

Hershal
 
D

D.Scott

#7
Duck!!!!! Incoming arrows !!!!!!!

"ABs do not create the markets, however if an internal lab is being used - depending on some variables - the controls on the internal lab may need to at the very least be strengthened to support accreditation. Often, a lab will find that internal labs may have significant benefit from accreditation. This is typically the case where a large test lab is doing a lot of internal cal.....then a potential non-conformity under clause 5.6.2.1.1 is certainly avoided."

This makes no sense to me. If the internal lab were not accredited, how could it have a non-conformity under a 17025 clause? How does the fact they are accredited make a non-conformity "certainly avoided"?

"and there are occasions where we might write a CAR on an internal lab....."

When would you find an occasion to write a CAR on a non-certified internal lab? Are you saying you are finding NC's during TS or ISO audits? If so, these are NCs under the requirements you are auditing, not 17025. Are you saying auditors are "raising the bar" on internal labs to promote accreditation?

"Why? ABs who are signatory to MRA (e.g IAS, A2LA, etc.) view accreditation as a serious responsibility on the part of both us and our accredited labs."

What does this mean? Has someone shown that the internal lab system as we know it is not a responsible function? Is there evidence that these labs are inefficient?

It almost sounds like someone is out drumming up new business.

Dave
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Hardly.

Under clause 5.6.2.1.1 the accredited lab has to use calibration providers that have demonstrated competence, measurement capability, and traceability. Often an internal lab has one or more disconnects there.

For example, if the internal cals do not include the measurement uncertainty, then there is no traceability, according to VIM (International Vocabulary of General and Specific Terms in Metrology).....that rates a non-conformance for lack of traceability for those calibrations, and a non-conformance under caluse 5.4.6.1 under uncertainty of measurement. If the internal lab is accredited then those provisions have been assessed.

Validated procedures must be used per 5.4.5.....a procedure that is not validated or considered validated (e.g. military procedures) rates a non-conformance.

17025 is FAR more involved than 9K and requires a full technical assessment besides the quality side.

Internal labs are often efficicient and capable.....but they must be able to support the "parent" lab's accreditation.....that means the internal lab MUST meet the same requirements, whether accredited or not.

Some may consider it drumming up business.....we consider it fulfilling the requirements under ISO/IEC 17025 and the requirements under ILAC and its regions.

Hope this helps.

Hershal
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
It occured to me after reading the posts again that the internal lab in the first post that the internal lab in question may be for a 9K or TS organization.....

If that is the case, as opposed to my immediate previous post regarding internal labs (see just below), then the AB likely won't even be there unless an application for accreditation is made. The reason is that under the rules we operate by (ISO/IEC 17011) we cannot do an evaluation for 9K or TS.....those evaluations are performed by organizations (Registrars) that are accredited under ISO/IEC 17021.....and under the ILAC/IAF agreement, ABs that accredit under 17011 should not cross over into 9K or TS, and ABs that accredit under 17021 should not accredit labs

Now, in economies where there is ONLY the Government owned/operated AB that obviously doesn't quite work that way, but to achieve ILAC or regional recognition (APLAC, EA, etc.) there must be separation between the two.

Hope this helps.

Hershal
 
D

D.Scott

#10
Yes, that clears it up Hershal. Thanks for the explanation. I couldn't figure why you would be going into a 9K or TS internal lab to find non-conformities. If it is for an internal lab of a 17025 certified company then it makes sense.

Thanks again.

Dave
 
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