ISO IEC 17043-2023 PDF

Full title and description

ISO/IEC 17043:2023 — Conformity assessment — General requirements for the competence of proficiency testing providers. This international standard specifies the requirements that proficiency testing (PT) providers must meet to demonstrate competence, impartiality and consistent operation of PT schemes across different fields of application.

Abstract

ISO/IEC 17043:2023 (Edition 2) updates and replaces the 2010 edition and sets out the general technical and management requirements for organisations that develop, operate and report proficiency testing schemes. It covers organisational competence, scheme design, sample preparation and handling, statistical treatment of results, reporting, confidentiality, complaints and appeals, and interaction with accreditation bodies and users. The revision reflects current practice and aligns with related conformity assessment standards and guidance used by accreditation bodies and ILAC signatories.

General information

• Status: Published (current international standard).
• Publication date: May 2023 (ISO/IEC 17043:2023, Edition 2).
• Publisher: International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) — published as a joint ISO/IEC standard.
• ICS / categories: 03.120.20 (Conformity assessment).
• Edition / version: Edition 2 (2023).
• Number of pages: ISO published edition: 36 pages (national/adopted EN/DIN/BS versions may show different pagination due to national forewords/translations and annexes).

Scope

The standard establishes general requirements for the competence and impartiality of proficiency testing providers and for the consistent operation of all proficiency testing schemes. It is applicable to PT providers of quantitative and qualitative schemes and may be used as a basis for development of sector- or discipline-specific requirements. ISO/IEC 17043:2023 is intended for PT providers, their customers, accreditation bodies, regulators and other stakeholders who rely on PT to assess performance.

Key topics and requirements

• Governance, impartiality and conflict-of-interest controls for PT providers.
• Management system and documented procedures covering scheme design, operation and review.
• Design of PT schemes including selection of materials, rounds, participant instructions and acceptance criteria.
• Preparation, homogeneity and stability assessment of PT test items and sample handling procedures.
• Statistical methods for assigned values, measurement of dispersion and calculation of performance scores (links to ISO 13528 guidance).
• Reporting of results, confidentiality, data integrity, and communication with participants and stakeholders.
• Complaints, appeals, nonconformities, corrective actions and continual improvement.
• Requirements for accreditation assessment and transition arrangements (implementation timelines advised by ILAC).

Typical use and users

Primary users are proficiency testing providers, accreditation bodies assessing PT provider competence, testing and calibration laboratories that participate in PT schemes, regulatory authorities that recognise PT outcomes, and organisations that develop or buy PT services. The standard is used to design, operate and evaluate PT schemes and to support accreditation decisions.

Related standards

Commonly used alongside and referenced with: ISO/IEC 17025 (competence of testing and calibration laboratories), ISO/IEC 17011 (requirements for accreditation bodies), ISO 13528 (statistical methods for proficiency testing), ISO 9001 (quality management), and other sector-specific conformity assessment standards. The 2010 version of ISO/IEC 17043 has been superseded by the 2023 edition.

Keywords

proficiency testing; proficiency testing provider; interlaboratory comparison; PT scheme; accreditation; conformity assessment; assigned value; homogeneity; stability; statistical methods; ILAC transition.

FAQ

Q: What is this standard?

A: ISO/IEC 17043:2023 is the international standard that specifies general requirements for the competence, impartiality and consistent operation of proficiency testing providers and the PT schemes they operate.

Q: What does it cover?

A: It covers organisational governance, scheme design, sample preparation and assessment (homogeneity and stability), statistical treatment and assigned values, reporting, confidentiality, complaints and continuous improvement — effectively the end-to-end requirements for running reliable PT schemes.

Q: Who typically uses it?

A: PT providers, accreditation bodies, testing and calibration laboratories (participants), regulatory authorities and organisations commissioning or using PT results. Accreditation assessors use it as the benchmark when evaluating PT providers.

Q: Is it current or superseded?

A: Current — ISO/IEC 17043:2023 (Edition 2) supersedes ISO/IEC 17043:2010. Accreditation bodies and ILAC members were advised of a transition period (three years from publication) for implementation and recognition under the ILAC arrangements (transition deadline: 31 May 2026).

Q: Is it part of a series?

A: It forms part of the ISO/IEC conformity assessment family (CASCO) and is commonly used together with ISO/IEC 17025, ISO/IEC 17011 and ISO 13528, among other standards and ILAC guidance documents.

Q: What are the key keywords?

A: Proficiency testing, PT provider, interlaboratory comparison, assigned value, homogeneity, stability, statistical evaluation, accreditation, impartiality, conformity assessment.