ISO/IEC 17043

ISO/IEC 17043
Title	ISO/IEC 17043
Scope	Conformity assessment — General requirements for proficiency testing
Status	Published
First published	2010
Developed by	ISO, IEC, ISO/CASCO
Related	ISO/IEC 17025, ISO 9001, ILAC, IAF

ISO/IEC 17043 is an international standard specifying general requirements for the competence of proficiency testing providers and for the development and operation of proficiency testing schemes. The standard is used by accreditation bodies, conformity assessment bodies, and laboratories to demonstrate impartiality, technical competence, and validity of comparative testing. Organizations adopt the standard alongside other frameworks to support mutual recognition, quality management, and regulatory compliance.

Scope and Purpose

ISO/IEC 17043 defines requirements applicable to organizations that design, prepare, and supply proficiency testing schemes for laboratories, inspection bodies, and certification bodies. Stakeholders use the standard to support International Organization for Standardization, International Electrotechnical Commission, International Laboratory Accreditation Cooperation, International Accreditation Forum, and national accreditation bodies such as United Kingdom Accreditation Service, National Institute of Standards and Technology, and Deutsche Akkreditierungsstelle in promoting comparability of results. The purpose includes enhancing confidence among participants like European Commission, World Health Organization, Food and Agriculture Organization, United States Environmental Protection Agency, and private sector entities.

Requirements for Competence of Proficiency Testing Providers

Providers must demonstrate organizational competence, impartiality, and technical capability to design and deliver schemes. Requirements reference technical competence expected by bodies including ISO/IEC 17025, ISO 9001, OECD, Codex Alimentarius Commission, and national metrology institutes such as Physikalisch-Technische Bundesanstalt, National Physical Laboratory (United Kingdom), and Bureau International des Poids et Mesures. Personnel competence, traceability to International System of Units, and calibration links to institutes like NIST and LNE are emphasized to meet needs of participants such as Centers for Disease Control and Prevention, European Medicines Agency, and private testing networks.

Design and Operation of Proficiency Testing Schemes

The standard guides scheme design, statistical methodologies, sample handling, and participant instructions. Providers must select appropriate reference methods such as those endorsed by AOAC International, European Committee for Standardization, Clinical and Laboratory Standards Institute, and interlaboratory studies organized like those by Inter-Laboratory Studies Group and Reed–Muench method adaptations. Operational elements include logistics, chain of custody with entities like Federal Bureau of Investigation evidence handling practices in forensic schemes, confidentiality aligned with protocols from World Trade Organization and reporting consistent with standards referenced by International Organization for Standardization technical committees.

Assessment and Validation Processes

Assessment under the standard involves validation of methods, homogeneity and stability testing of proficiency testing items, and rigorous statistical analysis. Validation practices draw on guidance developed by European Cooperation for Accreditation, International Union of Pure and Applied Chemistry, International Union of Biochemistry and Molecular Biology, and research outputs from universities such as Massachusetts Institute of Technology, University of Cambridge, and ETH Zurich. Schemes use z‑scores, robust estimators, and outlier tests consistent with methodologies from organizations like American Statistical Association and national metrology institutes. Peer review, proficiency testing of providers, and inter-accreditation comparisons support validation as practiced by ILAC and IAF.

Accreditation and Conformity Assessment

Accreditation of providers is performed by national and regional bodies following mutual recognition arrangements such as those between ILAC MRA signatories and IAF MLA economies. Conformity assessment processes align with policies of European Cooperation for Accreditation, United Kingdom Accreditation Service, Japan Accreditation Board, and China National Accreditation Service for Conformity Assessment. Accreditation demonstrates impartiality and technical competence, facilitating acceptance by regulatory agencies like European Chemicals Agency, U.S. Food and Drug Administration, and procurement authorities across multilateral organizations.

Implementation Challenges and Best Practices

Challenges include ensuring traceability to primary standards held by institutes such as PTB, managing matrix effects for complex samples as encountered by World Health Organization surveys, addressing resource limitations in regional bodies like Africa Accreditation and Inter-American Accreditation Cooperation, and harmonizing statistical approaches used by diverse participants including OECD member labs. Best practices recommend documented quality management systems referencing ISO 9001, transparent policies on conflict of interest modeled after Transparency International guidance, use of reference materials from providers like National Institute for Biological Standards and Control, and participation in international comparison programs organized by BIPM.

Historical Development and Revisions

The standard was developed through ISO and IEC technical committees with input from accreditation cooperations, national metrology institutes, and professional organisations such as International Federation of Clinical Chemistry and Laboratory Medicine and International Union of Microbiological Societies. Since initial publication, revisions incorporated evolving statistical science, microbiology proficiency practices influenced by outbreaks monitored by World Health Organization, and harmonization with accreditation frameworks driven by ILAC and IAF programs. Major updates reflected dialogue among stakeholders including European Commission Directorate-General for Health and Food Safety, national accreditation bodies, and laboratories in sectors represented by International Association for Analytical Chemistry.

Category:International standards