The International Organization for Standardization (ISO) published the 2nd edition of ISO 17043:2023 for proficiency testing (PT). The revisions to the standard were developed by a team of experts who were appointed by their respective national standards bodies. The Working Group had over 80 experts from 25 countries.
There are a few changes in the technical requirements of the standard. However, there are a great many changes to conform with current ISO requirements for common elements in all conformity assessment documents. The revised standard also more closely aligns with ISO/IEC 17025:2017 requirements for many of the structural requirements. Most of these changes will be familiar to PT providers that have laboratories or produce reference materials.
Most significantly, the new document acknowledges the applications of PT in areas other than testing and calibration, stating in the Introduction that PT can be used in any area of conformity assessment. There currently are accredited PT schemes that offer challenges in the areas of inspection, sampling, interpretation of results, and competence of individuals.
This second edition cancels and replaces the first edition (ISO/IEC 17043:2010), which has been technically revised.
The main changes are as follows:
— harmonization with ISO/IEC 17025:2017, including technical requirements and structure;
— harmonization with ISO 13528:2022 in terms of terminology;
— incorporation of requirements from ISO/CASCO PROC 33;
— inclusion of the requirement that testing activities, calibration activities and proficiency testing item production conform to the relevant requirements of appropriate ISO conformity assessment standards;
— deletion of Annex C and revision of Annexes A and B.
Proficiency testing (PT) is widely recognized as an essential tool for demonstrating the competence of conformity assessment bodies. PT can provide evidence of competence and it can be an indicator of an underlying or emerging problem.
The need for ongoing confidence in laboratory and other conformity assessment body performance is essential not only for the laboratories and other conformity assessment bodies, and their customers but also for other interested parties, such as regulators, accreditation bodies and other organizations that specify requirements for conformity assessment bodies including laboratories.