ISO/IEC 17025 is an International Standard developed according to the international best practices defined in the ISO/IEC Directives which includes circulation for voting to the national bodies of IEC and ISO, and approved by both organizations.
The third edition, published in November 2017, takes into account the numerous changes in market conditions that have occurred since 2005, when the second edition was issued. For instance, the Standard focuses on information technology, with a new section devoted to the use of computer systems and electronic records, as well as the production of electronic results and reports. The publication also puts the emphasis on the results of a process rather than on a detailed description of its tasks and steps.
The updated edition has also adopted a new structure aligned with the other Standards in the ISO/IEC 17000 series for conformity assessment.
The 2005 edition was split into two main sections: Management requirements and technical requirements. The 2017 version has five sections:
Laboratories have to commit to impartiality and confidentiality in their activities.
The laboratory is a legal entity that is legally responsible for its activities. As such, the laboratory has, among other things, identify management that has overall responsibility, define its organizational and management structure, the range of its activities, document its procedures and specify the role of anyone managing, performing or verifying work affecting the results of the laboratory.
This section describes in many details all facets, processes and procedures linked to personnel, facilities and environment, equipment, metrological traceability as well as externally provided products and services.
Process requirements address the review of requests, tenders and contracts, the selection, verification and validation of methods, sampling, the handling of tests or calibration items, technical records, the evaluation of measurement uncertainty, ensuring the validity of results, reporting of results, complaints, nonconforming work and the control of data and information management.
A clause in the management requirement section addresses risks and opportunities associated with the laboratory activities, a first in the history of ISO/IEC 17025. Addressing risks can include “identifying and avoiding threats, taking risk to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk or retaining risk by informed decision”. As for opportunities, they can “lead to expanding the scope of the laboratory activities, addressing new customers, using new technology and other possibilities to address customer needs.”
ISO/IEC 17025 enables laboratories to demonstrate that they are technically proficient and able to produce precise and accurate test and calibration data, thus promoting confidence in their work at the national, regional or international level. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Having test reports and certificates issued in one country accepted and recognized in many others, without the need for further testing, also helps improve international trade.
For more on the ISO/IEC 17000 series of International Standards, please visit the IEC Webstore