http://www.iso.org/iso/en/commcentre/pressreleases/2005/Ref956.html

Ref.: 956
12 May 2005

New edition of influential ISO/IEC standard on competence of laboratories

A new edition has just been published of an ISO/IEC standard acknowledged as the international benchmark for approving the competence of the testing and calibration laboratories that play a vital role in trade, in product development and manufacturing, and in protection of the consumer.

ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, replaces the 1999 edition which has been used to "accredit" (approve) some 25 000 laboratories worldwide that test products and samples, and calibrate precision instruments. However, the influence of ISO/IEC 17025 is even greater than this figure suggests since many countries make its use a legal requirement. In addition, documents derived from it are used by laboratories in specific sectors such as medicine and microbiology.

ISO Secretary-General Alan Bryden commented: "ISO/IEC 17025 benefits business, government and society at large. Confidence in the competence of laboratories is frequently needed by businesses when testing new products, or ensuring that finished products are fit for sale, by government regulators and trade officials that require assurance about domestic or imported products before they can be placed on the market, or for ensuring the quality and reliability of testing and analysis relating to environmental, health or safety hazards."

ISO/IEC 17025:2005 contains all of the requirements that testing and calibration laboratories need to meet in order to demonstrate to customers and regulators that they operate a sound management system which puts them in full control of their processes, are technically competent, and are able to generate technically valid results. Accreditation bodies that recognize the competence of testing and calibration laboratories will use the standard as the basis for their accreditation.

"Dependable testing and calibration laboratories are ones that have been duly accredited as competent and ISO/IEC 17025:2005 is the laboratory accreditation standard that, like the edition it replaces, will be counted on by business and governments worldwide," declared Peter van Leemput, who led the ISO group of experts that carried out the work.

The new, 2005 edition results from the amendment of ISO/IEC 17025:1999 to ensure its compatibility with the requirements of ISO 9001:2000, Quality management systems - Requirements. This became necessary because of the generalized adoption of quality management systems conforming to ISO 9001:2000, including many of the organizations that testing and calibration laboratories serve.

It also seeks to clarify that while compatible, the two standards are not inter-changeable. Although both standards can be used by laboratories as a framework for providing their customers with confidence that they are managing their activities, only ISO/IEC 17025 can be used to demonstrate the technical competence specific to laboratories.

Laboratories may choose to be accredited to ISO/IEC 17025, or be certified to ISO 9001:2000, or both, but the processes of accreditation and certification would still be two separate actions, although highly facilitated - both for the laboratories and the assessors - by the consistency now ensured between the two standards.

There are no essential changes to the technical requirements. The modifications relate mainly to the management requirements in the document to reflect the content of ISO 9001:2000, especially in a greater emphasis on the responsibilities of top management, on the need to demonstrate a commitment to continually improve the effectiveness of the management system, on customer satisfaction, and on internal and customer communication about the management system.

Peter van Leemput summed up: "Laboratories that have described and controlled their processes within the laboratory - as already required by the 1999 edition of ISO/IEC 17025 - will only have minor adjustments to make to their existing procedures to ensure that the new orientations in the management requirements are fulfilled."

The International Laboratory Accreditation Cooperation (ILAC) has set a transition period of two years from date of publication of the new edition - 12 May 2005 - for accredited laboratories to comply with the standard's requirements.

ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, costs 112 Swiss francs and is available from ISO national member institutes (see the complete list (http://www.iso.org/iso/en/prods-services/ISOstore/memberstores.html) with contact details) and from ISO Central Secretariat (see below). It was developed by Working Group 25 of ISO/CASCO, Committee on conformity assessment.

ISO Store: to order ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories (http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=39883&ICS1=3&ICS2=120&ICS3=20)

Thanks for the heads up, Sidney!

In point of fact, after reviewing the new version about a month ago......

The main changes involve the change of a few simple terms designed to realign it just a little closer to 9K in terminology.....there is no realignment of the clauses, no change of any actual requirements.....any accredited lab only needs to learn a few new terms.....no impact on the accreditation assessments.

ISO/IEC 17011 on the other hand, replaces Guide 58 and is a significant revision, including numerous requirements on the accrediting bodies, which of course will feed down to the labs. As an example, under 17011, a full reassessment is required every two years. The APLAC accrediting bodies (including IAS, who I work for) will have full implementation of 17011 by the end of CY 2005.

Hershal

I did some checking around and found 2 good articles that talked a little about the minor changes:

http://www.iso.org/iso/en/commcentre/pressreleases/2005/Ref956.html

http://www.compad.com.au/clients/ilac/memIndexPrev.php?updaterUrlPrev=siteArticleDisplay.php&artId=331

Sounds like mostly management improvement, customer feedback & the only tech thing seems to be continual improvement by evaluating training actions and monitoring QC data for incorrect items.

Jerry

Another note about the new revision of ISO/IEC 17025.....

ANSI has not yet picked up the new version as far as I know, so the U.S. version is still based on the 1999 revision, known here as ANSI/ISO 17025:2000. That is OK as the changes are minor.

Also, accreditation to 17025 satisfies all applicable requirements of ISO 9001:2000, so a test or cal lab does NOT have a need to be registered to 9K.....except as their custormer base demands.

Remember as you seek to find an accredited test or cal lab, review the scope to see if they can provide the service you need. Also check the accrediting body. In North America there are five that are MRA signatories and so are considered recognized (IAS, A2LA, NVLAP, L-A-B, SCC/CLAS). Outside North America, visit the ILAC website to find an accrediting body.

http://www.ilac.org

Hope this helps.

Hershal

We received the new 17025, 2nd edition 2005-5-15 from ANSI July 11.

Ours is due on last week of this month (29th July 2005).

Valeri, Can you please give some tips and share your experience of Audit. We were audited last month for this accrediation as a prelim. assessment. We made corrected and as per standard's requirement whatever was suggested by auditors.

Ours is due on last week of this month (29th July 2005). Valeri, Can you please give some tips and share your experience of Audit. We were audited last month for this accrediation as a prelim. assessment. We made corrected and as per standard's requirement whatever was suggested by auditors.

Which accreditation body is doing audit of your laboratory?

NPL Auditors are coming to audit our Lab Management System.

NPL Auditors are coming to audit our Lab Management System.

But NPL does not provide accreditation as per ISO/IEC 17025. Probably the auditors are working in NPL, and they are coming to do audit on behalf of some other accreditation body.

The AB for India is NABL. Good AB, and signatory to APLAC (Asia Pacific Laboratory Accreditation Cooperation).

http://www.aplac.org

Hershal

The AB for India is NABL. Good AB, and signatory to APLAC (Asia Pacific Laboratory Accreditation Cooperation).
http://www.aplac.org
Hershal

Is there any other AB operating in India? More than one body in any field bring competition and improvement in quality of service.

Ours is due on last week of this month (29th July 2005).

Valeri, Can you please give some tips and share your experience of Audit. We were audited last month for this accrediation as a prelim. assessment. We made corrected and as per standard's requirement whatever was suggested by auditors.
Manoj - I am going to be depending on this website for help - we are in the preliminary stages of obtaining certification. We won't be training until October. My expertise lies with automotive standards not labs - this is a brand new game for me. Sorry I couldn't be of more assistanct.

Is there any other AB operating in India? More than one body in any field bring competition and improvement in quality of service.

I don't believe so.....most economies have only one AB, which is often owned by the government.

Hershal

Hello Hershal,

Is there any reason to have only one AB in the field of Lab Certification? While in the field of Quality, Environment, Safety, Social Accountability even for CE marking there are many certification bodies as well as Accrediation bodies.

Second doubt is regarding Why AB related to Lab Accrediation System are Govt. owned?

Hard questions to answer.....I like that.

You are correct, for registration and certification, there are often several choices. Some economies do in fact have multiple accreditation bodies for lab accreditation also. The North American market is the most populated there, with five recognized bodies (IAS, A2LA, NVLAP, L-A-B, SCC/CLAS). Another economy with more than one AB is People's Republic of China (PRC) who technically has two ABs (CNAL, HKAS).

In the cases where the only AB is government owned, then typically the AB is affiliated with the National Measurement Institute (NMI) for the country. In the U.S. for example, NVLAP is affiliated with NIST.

Hope this helps a bit.

Hershal

Dear Manoj and Hershal,

I believe that an healthy competition brings improvement in the quality of service povided, and same goes for ABs or CBs. Absence of any competition creates a monopoloic tendency in AB, which incidentally is more difficult to operate than a CB. Moreover, if the AB is directly or indirectly related to the government its working becomes too bureaucratic and the body generally adopts a policing attitude and not the service attitude. It has been my experience in India, which has only one AB (NABL) giving accreditation to testing and calibration laboratories as per ISO 17025. This body even claims to have an authorization from the government that only it can give accreditation as per ISO 17025, which in my opinion is an absurd claim. No body can have exclusive rights on an international standard, such as, ISO 17025.

This body has also roped in various government organizations to put conditions on their suppliers to have test/calibration certificates from only NABL accredited laboratories. There is a case where a laboratory claims to have been accredited by UKAS but these organizations are forcing this lab to go for NABL accreditation if it wants its test/calibration certificaes to be accepted by them. India's NSB (BIS) is also forcing its clients (operating its product certification schems) to get their products tested and instruments calibrated from NABL accredited labs only.

India, very badly, needs another AB in this field. There is one AB which is trying to come up but is facing lot of problems in satisfying its potential client labratories to go for an AB other than NABL.