A new ISO/IEC standard establishes internationally harmonized requirements for verifying the competence of organizations that carry out proficiency testing of laboratories.
ISO/IEC 17043, Conformity assessment – General requirements for proficiency testing, specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.
Proficiency testing involves use of interlaboratory comparisons in the determination of a laboratory's performance and, more specifically, in its on-going competence. Laboratories demonstrate their competence by complying with ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, and the need for additional confidence in their results is achieved through their participation in interlaboratory comparisons managed by proficiency testing provider operating in accordance with ISO/IEC 17043.
The new standard 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 the following:
- Typical types of proficiency testing schemes
- Suitable statistical methods
- Selection and use of proficiency testing schemesby laboratories, accreditation bodies, regulators and other interested parties.
ISO/IEC 17043 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 the standard, comments, "There is intense international interest in ISO/IEC 17043. Many ILAC (International Laboratory Accreditation Cooperation) members and regions have plans to implement it and are actively planning or conducting training on the new standard. ILAC and its regional cooperations are taking steps to extend their Mutual Recognition Arrangements to include proficiency testing."
ISO/IEC 17043, Conformity assessment – General requirements for proficiency testing, was developed by working group WG 28 of the ISO Committee on conformity assessment (ISO/CASCO) and is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 136 Swiss francs, through the ISO Store or by contacting the Marketing, Communication and Information department (see right-hand column).