Comparison of ISO/IEC 17043:2023 and ISO/IEC 17043:2010 requirements for proficiency testing.

Abstract

Proficiency testing (PT), the evaluation of laboratory performance against predefined criteria through interlaboratory comparisons, is an essential component of a quality assurance system. PT provider must perform this activity and demonstrate the ability to evaluate performance correctly and appropriately. It is essential to operate under the international standard generally required for the competence of PT providers. The International Organization for Standardization has announced ISO/IEC 17043: 2010 as the first standard for PT.  The recent revision was ISO /IEC 17043:2023. The updated standard has been harmonized with other ISO/CASCO standards such as ISO/IEC 17025:2017 and ISO 15189:2022, facilitating easier integration with other management systems. To provide a better understanding, terminology definitions have also been updated to conform to ISO 13528:2022.  The new requirements have been adjusted from two main points of the first standard, technical and management requirements, to five main points: (1) general, (2) structure, (3) resources, (4) process, and (5) management system.   Including applying concepts of evaluation to ensure that the objectives of PT will be achieved, collection and analysis of feedback from participants and stakeholders and a risk and opportunity management process was added to increase the reliability of proficiency test results and deliver valuable services to customers.  Moreover, Annex A and B of ISO /IEC 17043:2023 have been revised to improve the standard and Annex C has been removed to focus on key points only. This review article intended to provide an overview of the changes that have been made to the standard for PT providers to better understand and be able to apply them to improve service quality. Delivering of accurate result of PT is valuable in reflecting the quality system. These promote laboratory quality assurance system for maximum benefit.