EN ISO/IEC 17043:2023/A11:2024

Overview

EN ISO/IEC 17043:2023/A11:2024 is the latest amendment to the European Standard that specifies the general requirements for the competence of proficiency testing providers. Prepared by the CEN-CENELEC Technical Committee CEN-CENELEC/JTC 1, this amendment updates and supplements the 2023 edition of EN ISO/IEC 17043. It aims to ensure that proficiency testing providers consistently demonstrate the skills and organizational structures necessary for delivering reliable, accurate, and impartial proficiency testing services within conformity assessment frameworks.

This standard plays a critical role in conformity assessment by defining how proficiency testing providers should operate to maintain trust and quality in testing processes through robust competence criteria. Proficiency testing is pivotal for laboratories, inspection bodies, and certification authorities that rely on inter-laboratory comparisons to validate their performance.

Key Topics

• Competence Requirements
  Defines the mandatory qualifications, skills, and organizational capabilities that proficiency testing providers must possess to carry out proficiency testing effectively.

• Structural and Resource Criteria
  Specifies minimum structural, technical, and human resource requirements necessary for providers to manage proficiency testing schemes reliably.

• Process and Management System Requirements
  Details the processes involved in designing, implementing, and managing proficiency testing schemes, including data handling, confidentiality, and reporting standards under a formal management system aligned with quality assurance principles.

• Compliance with European Regulations
  This amendment aligns with Regulation (EC) No 765/2008, supporting accreditation requirements within the European Union and associated EFTA states. Compliance confers a presumption of conformity, facilitating regulatory acceptance.

• Standardization and Harmonization
  Ensures uniformity and consistency across national standards of CEN and CENELEC member countries through mandatory adoption protocols by December 2024.

Applications

• Proficiency Testing Providers
  Enables providers to benchmark their competence and operational standards, thereby enhancing the credibility and reliability of their proficiency testing schemes.

• Laboratories and Inspection Bodies
  Supports laboratories that participate in proficiency testing by ensuring the quality and trustworthiness of testing schemes that validate their measurement accuracy and technical competence.

• Accreditation Bodies
  Acts as a reference for accreditation assessments, helping bodies verify that proficiency testing providers meet internationally recognized criteria.

• Regulatory Compliance
  Assists organizations in meeting EU and EFTA conformity requirements, improving acceptance of test results and certifications across member states.

• Quality Management Enhancement
  Encourages the implementation of robust quality management systems in proficiency testing, which leads to improved testing consistency and customer confidence.

Related Standards

• EN ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories, closely linked as proficiency testing supports laboratory accreditation.

• Regulation (EC) No 765/2008 – Regulation setting out requirements for accreditation and market surveillance within the EU, which this standard helps organizations comply with.

• ISO/IEC 17011 – Requirements for accreditation bodies accrediting conformity assessment bodies, ensuring uniform accreditation processes.

• EN ISO/IEC 17020 – Conformity assessment – Requirements for inspection bodies, which may also use proficiency testing providers following EN ISO/IEC 17043 standards.

Adopting EN ISO/IEC 17043:2023/A11:2024 ensures proficiency testing providers maintain high levels of competence, supports regulatory compliance across Europe, and fosters confidence in conformity assessment activities worldwide. This standard's alignment with critical EU regulations and its mandatory application across CEN/CENELEC member countries underscores its vital role in enhancing the integrity of proficiency testing services.