ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, is the definitive standard for testing and calibration laboratories, and it has now been updated to reflect the many technical changes and developments that have occured in the industry since it was last updated. It also now more follows the approaches of standards such as ISO-9001.
The original ISO/IEC 17025 standard, which was published by the International Organization for Standardization (ISO) in 1999, was created so that laboratories could develop competent quality control structures that would enable them to produce valid and reliable results that can be trusted. Trusted results being, of course, a core objective of any laboratory. In fact, in most countries a laboratory must have accreditation to this standard in order to be considered technically competent.
The standard has also fostered international cooperation by making the results of laboratory work in one country accepted in another without the need for retesting. This has also aided the development of international trade. The standard was previously updated in 2005, and ISO estimates that more than 100,000 laboratories around the world are currently following it, one way or another.
The updated standard contains the following guidelines:
- General Requirements
- Structural Requirements
- Resource Requirements
- Process Requirements
- Management Systems Requirements
It also has annexes on metrological traceability and management system options.
In the 12 years since the last update to the standard there have been many changes in the industry. Market conditions have changed and so has technology. The standard needed to reflect the new ways laboratories operate today, and encompass all the new activities in which they partake.
The new edition of the standard includes testing, calibration and sampling related to subsequent calibration and testing. It also has a process approach similar to newer standards like ISO-9001, ISO-15189 and ISO/IEC 17021-1, and it further pays more attention to the role of information technology, such as computers, electronic records and reports. Additionally, it includes a chapter on risk-based thinking.
The updated standard was prepared by ISO and the Eletrotechnical Commission, and the ISO Committee on Conformity Assessment is responsible for its content. Any laboratory previously accredited to 2005 updated standard will have three years to comply with the new edition and become re-accredited by a competent third-party organization.
ISO believes the new standard better aligns laboratories with their daily operations. These laboratories will now have a better understanding on how handle the statements of conformity and other reporting issues. ISO also believes that the new edition to the standard will help laboratories improve on how they deliver their services, by allowing them to view the risk of a poor result.