ISO 10012-1 vs ISO Guide 25/17025/Z540

Date: Tue, 4 May 1999 11:07:47 -0400
From: Jack Gale <jackgale@esscolab.com>
To: 'Greg Gogates' <iso25@fasor.com>
Subject: RE: News Article/ISO 10012 Vs ISO 17025

John and Leslie,

This is great that somebody may clear up the differences between ISO 10012-1 and ISO Guide 25/17025/Z540. Our customers are confused and it is hard to put them at ease when auditors and consultants put out things like "you must be accredited to ISO 10012-1" when it can't be done.

Section 1.3 of ISO 10012-1 states "This part of ISO 10012 is applicable to measuring equipment used in the demonstration of compliance with a specification: it does not apply to other items of measuring equipment." This part of ISO 10012 does not deal exclusively with other elements that may affect measurement results such as methods of measurement, competence of personnel etc.; these are dealt with more specifically in other International Standards, such as those referred to in 1.4." (Note : 1.4 mentions those labs operating under ISO/IEC Guide 25.)

This seems to backup the ISO 9001 statement that this may be used as guidance in addition to other standards that may more completely cover the entire topic. ISO 9001, Note 18 states:" The metrological confirmation system for measuring equipment given in ISO 10012 may be used for guidance." ISO9001 and ISO 10012-1 together would not be inclusive of all the requirements contained in G25/Z540. Add all these up and 10012-1 should not be used for cal labs:

1) It recognizes that it does not cover all the requirements for a cal lab that is done by ISO G25;

2) The use of "may" and "guidance" in the ISO9001 wording give it no clout;

3) Most practioners of metrology recognize G25/Z540 as the more complete document;

4) I do not know of any current third party auditor that will do ISO 10012-1; I have not heard of any major company placing that requirement ALONE (without G25) on an external cal lab;

5) and, lastly, ISO 10012-1 applies to "measuring equipment used in the demonstration of compliance with a specification;" I believe that calibration is beyond the scope of this statement.
We should let ISO 10012-1 be guidance for the users of measuring equipment and let ISO G25/17025/Z540 be for the calibration labs. This distinction would clear up many questions for customers. It may also be used by the AIAG to define what a customer has to meet for an internal cal lab, since this has not been defined some four months after QS9000 rev 3 (4.11.2.b.1) went into effect. A team has been assembled to see how to answer this one. This would also please the segment in our group that believe that ISO 9000 is insufficient for metrology and shouldn't be allowed.

A position statement from the NCSL would be an useful tool for the industry:

Example:

" ISO 10012-1 is to be used by suppliers administering their own calibration program and ISO/IEC Guide 25/ISO 17025 shall be the primary reference for independent calibration facilities or those required to meet ISO/IEC Guide 25/ISO 17025 requirements. Accreditation to ISO/IEC Guide 25/ISO 17025 by a competent auditor (ISO Guide 58) shall be considered equivalent to ISO 10012-1."

We could even further define the word "competent" above to get the "let's do Guide 25 audits" registrars out of the picture and leave it to the few truly qualified firms.

NIST is limited by their own rules from determining such things. NCSL could go a long way in filling this gap. I look forward to seeing the article.

Jack

Jack Gale
ASQ-CQE
Essco Cal Lab
jackgale@esscolab.com

[Marc]

I received the following e-mail:

Roxann M. wrote:

I know ISO Guide 25 has been revised and is set to be published as ISO/IEC 17025. I am trying to find out information on what was changed, added, deleted from the current Guide 25, when the new one will be available to the public and how I can get my hands on a copy. Any information would be appreciated.

Thank You.

RM

Anyone here know the answer?

[Marc]

From: "Doucet, Frank (INMS)" <Frank.Doucet@nrc.ca>
To: "'ISO 25 discussion group'" <iso25@quality.org>
Subject: ISO 10012 and ISO/IEC FDIS 17025 (still a draft but not for long - no more changes allowed)
Date: Thu, 8 Apr 1999 20:08:13 -0400

To: All concerned with the interactions of these two documents

These are some of my views that I would like to share and discuss with
anyone interested:

My views are that these two documents (ISO 10012 and ISO/IEC 17025) are supposed to address different situations and are both needed in the market. Because both of them deal with measuring equipment, it is reasonable to expect that they will overlap and cover similar subjects. ISO 10012 is a document supposed to be concerned with quality assurance requirements for measuring equipment at all levels of use from calibration labs to manufacturing activities, including incoming inspection, etc. On the other hand, 17025 is a document supposed to be concerned with the requirements for the competence of testing and calibration laboratories to assure that test and calibration results are technically valid. I will cite a some examples to emphasize these distinctions.

I am a buyer of a product and the contract that I have with the producer might include a stipulation that the measuring equipment used in all phases of manufacturing complies with ISO 10012. This requirement could be to assure that equipment are labeled properly (calibration status including cal date, due date, etc. ), and that adequate calibration intervals are established to give desired reliability levels, to name a few, with the main purpose of demonstrating the producers capability to provide reliable measurement results. In addition to this, the contract could stipulate ISO 9001 registration and accredited calibrations (17025) for all reference standards, etc. Someone might argue that 17025 will do the same thing in this case as 10012 and because of this, 10012 is redundant. Unfortunately requiring only 17025 will not assure that these requirements are met. For example, 17025 also requires labeling of equipment to indicate calibration status, but this requirement is only for equipment held by the lab and does not apply to equipment sent in for calibration by a client (although most labs will label client's equipment as a routine practice). In addition, 17025 stipulates that calibration reports and labels shall not contain any recommendation on the calibration interval, except where this has been agreed with the client.

These are only a few of the many possible examples and I'm sure that other readers will come up with more.

And finally, for those laboratories considering using 10012 instead of 17025, I would highly recommend comparing the two documents and I'm quite confident that after an objective comparison, 17025 will be the choice of the vast majority. This is because 10012 does not address a large percentage of the important aspects of a laboratory operation, including its competence.

-----------------
Frank J. Doucet, Technical Advisor, Electrical
National Research Council Canada
Institute for National Measurement Standards
Calibration Laboratory Assessment Service (CLAS)
M36-RM22
Ottawa, Ontario, Canada K1A 0R6
Tel.(613)993-0159 Fax.(613)952-1394
<mailto:frank.doucet@nrc.ca> frank.doucet@nrc.ca www.cisti.nrc.ca/inms/

[Marc]

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