ISO/IEC 17043 requirements explained: video brief

Clauses laid out like ISO/IEC 17025

ISO/IEC 17043:2023 has five requirement clauses, 4 to 8, laid out like ISO/IEC 17025:2017 rather than on the harmonised structure of management system standards. Clause 7 follows a scheme from contract to report, then complaints and appeals; clause 8 lists the minimum management system, which a quality management system, for example one meeting ISO 9001, can satisfy. Informative annexes cover types of proficiency testing scheme and statistical methods, with ISO 13528 as the statistical reference. This short film walks through the clauses.

Clause 4 asks the provider to undertake proficiency testing impartially, to monitor activities and relationships, including those of personnel, for threats to impartiality and remove or minimise them, and to manage information under legally enforceable confidentiality agreements. The evidence is an impartiality analysis of ownership, governance and relationships, and confidentiality arrangements with staff and external providers. Clauses 5 and 6 cover structure and resources, including competent personnel and controlled external providers.

The scheme process in clause 7

Clause 7 takes a scheme through its life: establishing the contract with participants; planning and designing the scheme; preparing proficiency test items, with homogeneity and stability considered; providing instructions to participants; handling items and data; analysing data with appropriate statistical methods; evaluating performance against criteria fixed in advance; reporting results to participants; and handling complaints and appeals. Clause 8 sets the management system requirements.

The standard applies to organisations that develop and operate proficiency testing schemes: commercial providers, metrology institutes, public health bodies, external quality assessment providers and laboratory networks. ISO/IEC 17043:2023 is the second edition, and the transition from the 2010 edition closed in May 2026. Accreditation is granted by an accreditation body for a defined scope of schemes and maintained through surveillance and reassessment.

Statistical methods must be valid, documented and suited to each scheme's objectives, and ISO 13528:2022 is the usual reference. Accreditation to the 2010 edition is no longer recognised now that the transition has ended, and the standard also applies to external quality assessment programmes for medical laboratories.