Inside Quality Insider

International Organization for Standardization ISO  |  03/17/2010

International Organization for Standardization ISO’s picture

Bio

ISO/IEC Standard to Keep Laboratory Testers on Their Toes

ISO/IEC 17043 addresses management, planning, design, and personnel of the proficiency testing provider.

(ISO: Geneva) -- A new ISO/IEC standard establishes internationally harmonized requirements for verifying the competence of organizations that carry out proficiency testing of laboratories.

The need for ongoing confidence in the competence of laboratories is not only essential for laboratories themselves and their customers, but also stakeholders such as regulators, laboratory accreditation bodies, and other organizations.

ISO/IEC 17043:2010—“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 ongoing competence. Laboratories demonstrate their competence by complying with ISO/IEC 17025—“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 a 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 schemes by 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.

“There is intense international interest in ISO/IEC 17043,” says Dan Tholen, convenor of the group of experts that developed the standard. “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. ILAC and its regional cooperations are taking steps to extend their mutual recognition arrangements to include proficiency testing.”

ISO/IEC 17043 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.

Discuss

About The Author

International Organization for Standardization ISO’s picture

International Organization for Standardization ISO

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.