Évolutions of the standard ISO/IEC 17025:2017

L' ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" is a widely-used standard, with over 40,000 accredited laboratories worldwide, including almost 2,000 in France. It is one of the most widely prescribed standards, for CE marking and official laboratory approval, for example. Although this regulatory context is increasingly present, a large number of laboratories apply it on a voluntary basis, the aim being to provide their customers with guarantees in terms of impartiality, competence, traceability and suitability of the measurements carried out (tests, analysis, calibrations) to their needs.

Since 2005, when the previous version of this standard was published, the context has evolved considerably: vocabulary has been adapted to new practices; technologies have undergone profound changes, notably with the dematerialization of data; a single "schema" for accreditation standards in the ISO/IEC 170XX series has been created; the approach to quality management has benefited from significant developments, notably with the various revisions of the ISO/IEC 170XX standard. ISO 9001 and the concept of process... A thorough review of the ISO/IEC 17025 had become necessary to adapt it to this new context.

France was heavily involved in the revision of this standard, with the presence of three experts on the ISO technical committee (TC), and strong activity on the XA50 mirror commission at AFNOR. It should also be noted that the publication of this standard coincides with that of the ISO/IEC 17011 applicable to accreditation bodies, which represents a double challenge for them.

In this context, new trends are emerging in the new standard. Its scope has changed, incorporating the concepts of impartiality and consistency of laboratory activities. It is based on a risk-based approach, while becoming less prescriptive, with a requirement for results rather than means. In addition, it incorporates the requirements of the International Laboratory Accreditation Cooperation (ILAC), which were already included in Cofrac documentation, the requirements being generally more comprehensive and explicit.

In this context, the aim of the article is to develop the content of the standard in order to apply it pragmatically and in a spirit of continuous improvement.