The International Organization for Standardization (ISO) published a new version of ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories. The standard, according to the ISO, is acknowledged as the international benchmark for approving the competence of the testing and calibration laboratories that play a vital role in trade, product development, manufacturing and consumer protection.
ISO/IEC 17025:2005 replaces the 1999 edition which has been used to "accredit" 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, said the ISO, 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/IEC 17025:2005 contains the requirements that testing and calibration laboratories need to meet to demonstrate that they operate a sound management system giving them 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 generalized adoption of quality management systems conforming to ISO 9001:2000, including many of the organizations that testing and calibration laboratories serve.
ISO/IEC also clarifies that while compatible, the two standards (ISO/IEC 17025 and ISO 9001) are not interchangeable. 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 in the new standard. The modifications relate mainly to the management requirements in the document to reflect the content of ISO 9001:2000, especially a greater emphasis on:
The responsibilities of top management. The need to demonstrate a commitment to continually improve the effectiveness of the management system. Customer satisfaction. Internal and customer communication about the management system.
"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," said Peter van Leemput, who led the ISO group of experts that carried out the work on the revision.
The International Laboratory Accreditation Cooperation (ILAC) has set a transition period of two years from date of publication of the new edition - May 12, 2005 - for accredited laboratories to comply with the standard's requirements.
It was developed by Working Group 25 of ISO/CASCO - Committee on conformity assessment.
"ISO/IEC 17025 benefits business, government and society at large," said ISO Secretary-General Alan Bryden. "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."
Source: International Organization for Standardization (ISO).
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