Overview
EN ISO/IEC 17043:2023 - titled Conformity assessment - General requirements for the competence of proficiency testing providers - specifies the general requirements that proficiency testing (PT) providers must meet to demonstrate competence, impartiality and consistent delivery of PT schemes. Published in 2023 and adopted by CEN as EN ISO/IEC 17043:2023, this second edition replaces the 2010 version and aligns the standard with recent conformity-assessment and statistical guidance.
Key topics and requirements
The standard covers both organisational and technical requirements, including:
- General principles: impartiality, confidentiality and conflict-of-interest controls.
- Structural requirements: governance and responsibilities for PT delivery.
- Resource requirements: competent personnel, suitable facilities and control of externally provided products and services.
- Process requirements: end-to-end management of PT schemes, such as:
- Establishing, contracting and communicating PT scheme objectives and scope.
- Design and statistical planning of PT schemes (statistical design, sampling and uncertainty considerations).
- Determination of assigned values used to evaluate participant results.
- Production, homogeneity and stability assessment, packaging and distribution of PT items.
- Evaluation and reporting: data analysis, performance evaluation and participant reports.
- Control of records, data management, surveillance of processes, and handling of nonconforming work, complaints and appeals.
- Management system requirements: documentation, risk-based actions, internal audits, corrective actions and management reviews.
The 2023 edition explicitly harmonizes with ISO/IEC 17025:2017, adopts terminology aligned with ISO 13528:2022, and incorporates aspects of ISO/CASCO PROC 33.
Practical applications and users
EN ISO/IEC 17043:2023 is used to:
- Accredit proficiency testing providers and demonstrate competence to accreditation bodies.
- Design and run PT schemes for laboratories, inspection bodies and other conformity assessment organizations.
- Support laboratory quality assurance by providing independent inter-laboratory comparisons and verifying measurement performance.
- Meet regulatory or contractual requirements where participation in or provision of PT is mandated.
Primary users include PT scheme providers, accreditation bodies, testing and calibration laboratories, regulators and organizations procuring PT services.
Related standards
- ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories.
- ISO 13528:2022 - Statistical methods for proficiency testing by interlaboratory comparison.
- ISO/CASCO PROC 33 - Proficiency testing procedure guidance.
Keywords: EN ISO/IEC 17043:2023, proficiency testing providers, conformity assessment, PT schemes, assigned values, homogeneity and stability, statistical design, ISO/IEC 17025, ISO 13528.