Overview
ISO/IEC 17043:2023 - Conformity assessment - General requirements for the competence of proficiency testing providers - defines the general requirements for the competence, impartiality and consistent operation of proficiency testing (PT) providers and PT schemes. The 2023 second edition updates and harmonizes requirements with other conformity assessment standards and provides a common basis for accreditation, peer-assessment and regulatory recognition of PT providers. The standard covers the full PT lifecycle from scheme design and statistical planning to production, distribution, evaluation and reporting.
Key topics and technical requirements
ISO/IEC 17043:2023 addresses both management and technical elements essential to reliable proficiency testing. Major topics include:
- Impartiality and confidentiality: organizational safeguards to avoid conflicts of interest and to protect participant information.
- Structural and resource requirements: governance, documented responsibilities, qualified personnel, facilities and external suppliers.
- Process requirements: end-to-end control of PT schemes including:
- Establishing, contracting and communicating PT objectives and scope
- Design and statistical planning of schemes (statistical design, sample size, uncertainty considerations)
- Determination of assigned values and procedures to ensure validity and traceability
- Production, homogeneity and stability assessment of PT items, handling, packaging, labelling and distribution
- Instructions for participants, data analysis, evaluation of participant performance and reporting
- Control of data and records, surveillance of processes, and handling nonconforming work
- Management system requirements: documented management system, control of documents and records, risk and opportunity management, continual improvement, internal audits and management review.
- Governance of complaints and appeals: transparent processes for participant concerns.
- Informative annexes on types of PT schemes and statistical methods for PT support practical implementation.
Practical applications and users
ISO/IEC 17043:2023 is used to:
- Design, operate and improve proficiency testing schemes and interlaboratory comparisons.
- Provide objective evidence of PT provider competence for accreditation bodies, regulators and customers.
- Support laboratories and other conformity assessment bodies in demonstrating competence through participation in PT.
- Guide organizations implementing peer-assessment schemes or requiring third‑party PT services.
Typical users: PT providers, national and international accreditation bodies, regulators, laboratories, conformity assessment bodies and scheme organizers.
Related standards
ISO/IEC 17043:2023 is harmonized with and complements:
- ISO/IEC 17025:2017 (testing and calibration laboratory competence)
- ISO 13528:2022 (statistical methods for PT)
- ISO/CASCO PROC 33 and other CASCO guidance documents
Keywords: ISO/IEC 17043:2023, proficiency testing, PT providers, proficiency testing schemes, interlaboratory comparisons, accreditation, assigned values, statistical design.