Laboratory Accreditation vs. Registration - The Differences

[Marc]

Date: Tue, 2 Feb 1999 19:09:53 -0500
From: "Ouellette, Mike (INMS)"
To: Greg Gogates
Subject: Registration vs Accreditation

Greetings Patrick Calway,

You are correct that only an accreditation body can accredit a laboratory's measurement capabilities. That's done to Guide 25. It involves an assessment of the quality system to Guide 25 and, quite importantly, it involves an expert review of the laboratory's technical proficiency of the specific measurement capabilities and verified traceability, complete with stated uncertainties, to national measurement standards. In the US, its done by NVLAP ( http://ts.nist.gov - Link was: /ts/htdocs/210/214/214main.htm ) and A2LA ( http://www.a2la2.net/ ). Since I see that you're writing from Canada, I'll toss in the plug for the Standards Council of Canada ( http://www.scc.ca - link was: /palcan ) who's the exclusive body for accreditation, to Guide 25, of test and cal laboratories in Canada. They do it through the assessment services of the National Research Council ( http://www.nrc.ca - Link was: /inms/clas/clase.html ). See the latter site for related reference documentation including http://www.nrc.ca - the link was: /inms/faq/isofaqe.html, a detailed discussion paper on the differences between registration and accreditation.

In short, the paper says that registrars are qualified only to register quality systems, not proficiency or capability to produce quality product. They therefore cannot accredit. ISO 9000 is the most common quality system model. QS 9000 is a specialized version of that for the automotive industry. A company making bikes with square wheels could, as an absurd analogy, be registered to ISO 9000. Accreditation would be impossible, however, because the product would not pass scrutiny.

Quality system registration (ISO 9000) asks:
1.Have you defined your procedures?
2.Are they documented?
3.Are you following them?

IN ADDITION, laboratory accreditation (ISO/IEC Guide 25) asks:
4.Are they the most appropriate test or calibration procedures to use in the
circumstances?
5.Will they produce accurate results?
6.Have you validated the procedures to ensure their accuracy?
7.Do you have effective quality control procedures in place and implemented
to ensure ongoing accuracy?
8.Do you and your laboratory personnel understand the science behind the
test or calibration procedures?
9.Do you know the limitations of the procedures?
10.Can you foresee and cope with any technical problems that may arise while
using these procedures?
11.Do you have all the correct equipment, consumables and other resources
necessary to perform these procedures?

I believe version 3 of QS 9000 calls for all externally-calibrated reference stds to be done by laboratories accredited by recognized bodies including SCC in Canada and A2LA in the US. This, presumably, is to give assurance of the quality of the calibration service and assurance of traceability through a verified chain of comparisons with stated uncertainties at each link. Details are available at the Guide 25 homepage at http://www.fasor.com - the link was: /~iso25/. The short-term problem is that the US presently has too few accredited cal services to meet the expected demand. It might also become the case in Canada, if it's not already in some areas of measurement. Right now, however, some of our accredited labs (listed at http://www.nrc.ca - the link was: /inms/clas/sccacle.html ) have told me as recently as this week that they are still waiting to see some business. Nevertheless, registrars are now offering their services to assess and register the laboratories' conformance to the quality system elements of Guide 25 without assessing technical competence. While their efforts will no doubt help to clear a log jam, your confusion is evidence of some of the problems this might create.

I hope this long winded explanation will help. Give me a call if you'd like to discuss further.

Mike Ouellette,
Technical Advisor, Electrical
Calibration Laboratory Assessment Service
National Research Council Canada
Ottawa, ON, K1A 0R6
tel. 613-993-9619
[email protected]
http://www.nrc.ca

 

[Marc]

Date: Tue, 2 Feb 1999 19:36:35 -0500
From: "Peter S. Unger"
To: 'Greg Gogates'
Subject: RE: ISO Guide 25 certification vs accreditation and A2LA

It is apparent that several ISO25 participants want an "official word" from A2LA on the Guide 25 "certification" debate. So here goes.

ISO/IEC Guide 25 was originally developed by the International Laboratory Accreditation Conference (now Cooperation) in 1978 to provide universal criteria for accreditation (i.e., a formal recognition of competence to specific tests/calibrations). Guide 25 provides one of the key pillars to the foundation upon which to build mutual recognition arrangements among accreditation bodies. But Guide 25 can be used for other purposes. For example, it has served as a good reference for laboratories to develop their quality systems. The use of Guide 25 for "certification" in the ISO 9001/2 registration/certification sense was not contemplated originally and should be discouraged, mainly because it causes so much confusion in the marketplace. However, this is a free country and world (we simply cannot outlaw the practice) and if laboratory users wish to require laboratories to be "certified" to Guide 25, this is their prerogative. Just be aware that "certification" is a distinctly different type of recognition than "accreditation". Many people do not understand the distinction and therefore use the terms interchangeably. This leads to further confusion as evidenced by the use Guide 25 for certification.

The standards developers do not help matters much as we see ISO TC 176 developing a "requirements" standard (ISO 10012, Quality assurance for measuring equipment to support metrological confirmation systems). Many do not see the need for yet another "requirements" document dealing with laboratories. There are very few laborotories actually participating in its development, perhaps because they see no need for it. But as these standards proliferate, the labs will be faced with redundant or even conflicting requirements that customers will inevitably place upon them.

On another issue, ANSI Z540.1 is the U.S. version of Guide 25, but tailored to calibration laboratories only. Guide 25 applies to both calibration as well as testing laboratories. ISO 17025 is intended to replace not only Guide 25 but (we hope) all differing regional and national versions.

A2LA accredits calibration laboratories using Guide 25 as the general criteria, but augmented by a couple of unique, added clauses in Z540.1 (so that we can say the lab also meets Z540.1) and by specific criteria related to A2LA accreditation of calibration labs. So if a lab wants Guide 25 accreditation and Z540.1 accreditation it gets both with A2LA at the same time.

One thing for sure -- this will not be the last word on this subject.

Peter Unger, A2LA President
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704-8373
Direct Phone Line: 1 301 644 3212;
Fax: 1 301 662 2974;
Main Line: 1 301 644 3248

For related topic, see: http://Elsmar.com/ubb/Forum4/HTML/000063.html - NACLA

 

[Marc]

Date: Wed, 3 Feb 1999 07:34:50 -0500
From: Lynne
Subject: Re: Re15: A2LA vs. ISO Guide 25 (fwd)

Absolutely no one has given NVLAP or A2LA credentials to do anything. They are not approved by anyone for any part of their program except for the fasteners act and an EPA program. The rest of the recognitions come from the users accepting their accredited labs data. Laboratory accreditation bodies do have a peer review process that they use for mutual recognition arrangements, but there is no oversight authority like RAB is for registrars.

There are no rules for whether you can or can't certify to Guide 25. It is general practice that accreditation applies to laboratories and G 25, and that certification/registration applies to ISO 9000, but Guide 25 can be used to register a laboratory.

I realize that this whole situation goes against the grain of those of us who have long been advocates of accreditation, but the facts are the facts. My opinion of this situation is shock an abhorrence because I don't think that this is appropriate, but my opinion doesn't count in this. GM is in a tough position, they want their manufacturer's to be compliant with QS 9000 third edition, and they probably felt that having labs certified to G25 would put more resources on the issue to hurry this process along.

I'm sorry if this has gotten everyone's ire up, but GM has asked these registrars to jump, and they have asked "How high"? For a couple of these registrars GM is their largest client. What would you do?

 

[Marc]

Date: Wed, 3 Feb 1999 18:32:50 -0500
From: "Ouellette, Mike (INMS)"
Subject: Authority of Accreditation Bodies

As far as I know, the situation that Lynne describes applies only to the USA where accreditation bodies act by-and-large on their own authority. Most elsewhere, accreditation bodies received their authority from their national governments. In Canada, the authority is given to the Standards Council of Canada ( http://www.scc.ca ) through the Standards Council Act. The organization reports to Parliament through the Minister of Industry. In Mexico, the authority is given by la Administración Pública Federal to the Direccion General de Normas of the Estados Unidos Mexicanos (DGN).

The SCC, as does NVLAP and A2LA, operate in accordance to ISO/IEC Guide 58 "Calibration and Testing Laboratory Accreditation Systems - General Requirements for Operation and Recognition." The document is to accreditation bodies what Guide 25 is to cal & test labs. It "sets out the general requirements for the operation of a system for accreditation of calibration and/or testing laboratories so that the accreditations granted and the services covered by the accreditations may be recognized at a national or international level and the body operating the accreditation system may be recognized at national or international level as competent and reliable." This Guide is a basis of the peer review process that Lynne discussed below.

Mike Ouellette, Technical Advisor, Electrical
Calibration Laboratory Assessment Service
National Research Council Canada
Institute for National Measurement Standards