A new ISO/IEC Standard establishes internationally harmonised requirements to verify the competence of organisations that carry out proficiency testing of laboratories. Conformity assessment – General requirements for proficiency testing ISO/IEC 17043:2010, specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.
The need for confidence in the competence of laboratories is essential for laboratories themselves and their customers, and stakeholders such as regulators, laboratory accreditation bodies, and other organisations.
Proficiency testing involves use of inter-laboratory comparisons in the determination of a laboratory's performance and in its ongoing competence. Laboratories demonstrate their competence by complying with General requirements for the competence of testing and calibration laboratories ISO/IEC 17025:2005.
ISO/IEC 17043 addresses management, planning, design, and personnel of the proficiency testing provider. In addition to requirements on the development and operation of proficiency testing, it contains informative annexes on:
- typical types of proficiency testing schemes
- suitable statistical methods
- selection and use of proficiency testing schemes by laboratories, accreditation bodies, regulators, and other interested parties.
ISO/IEC 17043:2010 is an improvement on and replacement for the two-part ISO/IEC Guide 43:1997.
Dan Tholen, convenor of the group of experts that developed ISO/IEC 17043, comments, 'There is intense international interest in ISO/IEC 17043. Many International Laboratory Accreditation Cooperation (ILAC) members and regions have plans to implement it and are actively planning or conducting training on the new Standard.'
- ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories