How to Integrate ISO 17025 with current QMS

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#21
Hello all! I have some questions on the beginning phase of ISO 17025.

Our calibration lab is under a mature QMS (ISO9001- 10+ years; regulated industry; 1000-4000 employees). For discussion, I will specify the current, comprehensive sytem as the "large" system, and the calibration activities program as the "small" system.

As we sit, my assessment is we have a good program (small and large). There is interest, for various reasons, to fall under the 17025.

For the most part, most of the components specified is 17025 are encompassed within the larger system. We already have procedures in place to handle:

Purchasing
Calibration records
Management/ management review
Nonconforming product
Corrective action program
Document control....
Among others

There does not appear on the surface to be any reason why these would be deficient within the "small" system.

NOTE: There are a few I have identified that need addressing.

Currently (and in the foreseeable future) there will only be internal customers.

So, am I hearing that in the end, it will be better to create a new quality system within the system? So, do I "pretend" that the larger umbrella system does not exist, and create from scratch?

Too, I cannot imagine that the quality professionals responsible for the large system would be completely OK with creating a small system independent of the large. That is my thought; but nothing verified on that one.

Your thoughts, input, and opinions are welcome.:)
Brad,

First, if you have a copy of ANS/ISO/IEC 17025:2005, great, if not, first thing is to purchase it, likely the best price is from NCSLI http://www.ncsli.org

Now, pick it apart word by word and line by line, write everything down that is a requirement. For example, Management Review has a prescriptive agenda that you must be aware of, including topics that may not be a requirement under ISO 9001.....purchasing, watch criticals; sub-contracting (if any) watch how you qualify organizations; Clause 5.9.1 requires special attention and for it also obtain APLAC PT 001 and PT002, both are free at http://www.aplac.org and similar specific requirements are throughout the Standard.....

Now, go through your already-documented QMS word by word and line by line.....WHERE everything matches up, use the parent system.....where you can't absolutely put a peg in the sand that there is a match, then document.....

GET TRAINING!!!!!!! Training in ISO/IEC 17025 and in Measurement Uncertainty.....there are a number of courses available.....

Do your uncertainty, a requirement for traceability of calibration and a great early warning system for problems in the technical arena.....

It is unlikely that you will seek accreditation, but if you do remember there are FIVE accrediting bodies (ABs) in the U.S., and do NOT choose one till you have quotes from all five and have spoken to all five, and called a good sample of their customers.....

Hope this helps.

Hershal
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#22
2. Uncertainty calculations

I would like to see if it is feasible to go with what we currently have for the technical portion. We have established at least 4 to 1 accuracy ratios for our standards. We have a few less than 4 to 1, as the current technology limits the possible standards. This is the fundamental comparison of the tolerance of our standard, compared to the tolerance of the U.U.T.

We have not performed extensive uncertainty calculations. This is due to two components- 1) Assuring proper accuracy ratios has been deemed sufficient; 2) we have somewhere between 75-175 standards.:tg: Of course, these (accuracies) are documented in several places within the system. I do need to get these into one document.

As for the 4:1, first, to be absolutely clear, it is allowed and at times even directed under the now-retired American National Standard ANSI/NCSL Z540-1-1994 and also allowed under the current ANSI/NCSL Z540.3-2006.....key is, you must be able to prove it, so you still have to do uncertainty studies.....
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#23
It was explained to be that most accreditors will cite for using a non-accredited lab, then the customer “appeals” through the Corrective Action for the nonconformance. Why would I want (and why would you want a system) to enter with a known problem? I agree it should be highly preferred, but seems a bit aggressive to mandate it. Your thoughts…
According to the Standard, simply because a supporting lab is not accredited, that is not worthy - in and of itself - of a corrective action, because the Standard does in fact provide some leeway.....however, there must then be sufficient documentation to prove the ACTUAL requirements of the Standard which are: traceability, competence, and measurement capability, according to Clause 5.6.2.1.1 which addresses traceability.....

Side note, the IAS policies are available at no cost on their website, as are the policies for A2LA, L-A-B, ACLASS, and NVLAP on their resepctive websites.

Hope this helps.
 
Last edited by a moderator:

BradM

Staff member
Admin
#24
Thanks, Cliff. Excellent as usual.

The audit report includes all audit activity, including follow up, presumably by the auditor. The auditor can explain how he cleared the NC
But that's my point. Generally an auditory cites the clause and evidence of non-conformity. The correction/corrective/preventive action usually is the domain of the auditee, not the auditor. Some things may be easy fixes while they are there; some will take a while.
 
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