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
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