Update of ISO 17043 Standard: Key Changes and Benefits for Conformity Assessment

The new version of the ISO 17043 standard, published in May 2023, represents a significant step forward in the standards governing proficiency testing and the competency requirements for their providers. This update replaces the original 2010 edition and reflects a more comprehensive approach that aligns with other conformity assessment standards, such as ISO 17025:2017 and ISO 13528:2022. Through a revised structure, changes to requirements, and greater attention to aspects like transparency and risk-based analysis, the standard establishes a more robust framework to ensure the quality and reliability of these types of services. Both providers and users of proficiency testing, including laboratories dedicated to testing, calibration, or sampling, will benefit from these changes, albeit in different ways.

Since their inception, proficiency tests have been a key resource for assessing technical competence and ensuring the quality of results obtained by laboratories and other entities involved in testing activities. However, technological developments, new regulatory expectations, and the experience accumulated over the past decade have made it necessary to review and update the principles governing this practice. The 2023 version of ISO 17043 addresses these needs and establishes a clearer standard aligned with the current realities of the sector.

Main Focus of the ISO 17043 Standard and Alignment with International Standards

The main conceptual difference in the new edition of the standard lies in its emphasis on the competence of proficiency testing providers rather than solely focusing on conformity assessment activities. This change reflects alignment with the direction taken by ISO 17025, which also prioritizes the evaluation of the competence of laboratories conducting testing, calibration, or sampling. Additionally, the scope of proficiency testing has been expanded, now recognized as applicable not only to testing and calibration activities but also to sampling and inspection processes.

One of the most significant innovations in this version is the harmonization of terminology with ISO 13528:2022. This integration allows for more consistent use of statistical concepts in proficiency testing, facilitating their practical application and improving understanding among involved parties. By incorporating common requirements from ISO/CASCO PROC 33, the standard also ensures greater uniformity in matters related to impartiality, confidentiality, complaint and appeal management, as well as management system design.

To read the full article, please visit our website: Read more