Understanding of, and Pros and Cons of, 17025

[Trolle]

Digest 17025?

Is there anyone who can direct me to a internet link where one can digest the 17025 standard?

Is there anyone out there who has opinions on the pro and cons of this standard?

Especially related to ISO/TS 16949 7.6.3.1?

Cheers!

 

[Marc]

I would start at Greg Gogates site: https://www.fasor.com

 

[M Greenaway]

ISO/IEC 17025 is the quality management system requirements for test laboratories, and is was based on the 1994 standard of ISO9001.

The pro's of searching for this accreditation from your test/calibration suppliers is that you have confidence that the calibration/test is traceable to national standards of measurement, and the test methods involved conform to established requirements or best practice.

The pro's of having your own test/cal lab accredited to this standard is that you can offer independantly accredited/traceable test/calibration certificates.

I cant think of any con's, other than obviously if you dont need it then dont go/look for it.

I believe TS16949 requires that any external test houses are accredited to this standard.

 

[Ryan Wilde]

Hi all,

Marc's link is to the uncopyrighted "draft" version (hence the ISO/DIS instead of ISO/IEC) of the standard, but it is very close to the final, so for informational purposes, it should do nicely.

I cannot really relate the pros/cons from a standpoint of ISO/TS 16949 7.6.3.1, as I've not been in a production environment since these fancy quality systems have appeared.

I can, however, comment on the pros/cons of 17025 from the standpoint of a calibration lab.

Pros:

Quality of services go way up in a lab that strictly adheres to 17025. The laboratory personnel are far more aware of what they are doing, why they are doing it, and how to prove that what they are doing is adequate.

Traceability to National/International/Intrinsic/Consensus standards is about as close to guaranteed as you can get.


Cons:

Money. Most people know that accreditation is expensive. But, the actual accreditation is only about $5000-8000 for the first year, and cheaper after that. The real expense is the steps required to be fully compliant to the standard. Whenever I see that someone claims to be "compliant", but do not want to pay the expense of full accreditation, I tend to believe that they are not fully compliant, or they would spend the last few thousand dollars and become accredited. Our preparation for accreditation cost somewhere in the region of $80-100k for time, standards, systems, etc.

Time. Complying with the standard costs time with each and every calibration. Computing a true measurement uncertainty can double or triple the time to calibrate an item (mechanical gauges are fairly simple, electronic gauges get quite complex). Following the data collection rules takes time. In-process checks take time. Everything that the standard requires adds time.


The pros and cons list is probably quite similar to that of any quality document, actually. I do have to let you in on the difference, however, between 17025 and "quality systems". ISO/IEC 17025 is a competency document. It has a quality system in section 4, but section 5 is entirely dedicated to laboratory competency and adequacy. It is much less generic, and gets quite specific on several things, unlike ISO 9000 and ISO 16949. The assessment is performed by people that actually work in the disciplines that they assess, and have a minimum of 10 years experience in the field. The assessors actually spend most of their time verifying technical knowledge, adequacy, and technician competency rather than a "paper trail".

I hope this helped a bit,

Ryan