New edition of 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 25000 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. This new standard is now available at the SLSI (Sri Lanka Standards Institution) library.

This is a welcome sign for Sri Lankan laboratories engaging in medicinal testing, since a lot of criticism is often made on medical laboratories on the credibility of their test reports.

Those laboratories could also be accredited against this standard by complying with the requirements stipulated therein. By doing so, they will be able to streamline their testing processes, bringing more credibility to their test reports and alleviating the discrepancies that generally prevails over the test reporting.

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.

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 generalised adoption of quality management systems conforming to ISO 9001:2000, including many of the organisations 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.