ISO/IEC 17043:2023
Conformity assessment — General requirements for the competence of proficiency testing providers
This document specifies general requirements for the competence and impartiality of proficiency testing (PT) providers and consistent operation of all proficiency testing schemes. This document can be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies and others can use these requirements in confirming or recognizing the competence of proficiency testing providers.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Impartiality
4.2 Confidentiality
5 Structural requirements
6 Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Externally provided products and services
7 Process requirements
7.1 Establishing, contracting and communicating the PT scheme objectives
7.1.1 Review of requests, tenders and contracts
7.1.2 PT scheme communication
7.2 Design and planning of a PT scheme
7.2.1 General
7.2.2 Statistical design
7.2.3 Determination of assigned values
7.3 Production and distribution of PT items
7.3.1 Production of PT items
7.3.2 Homogeneity and stability assessment of PT items
7.3.3 Handling and storage of PT items
7.3.4 Packaging, labelling and distribution of PT items
7.3.5 Instructions for participants
7.4 Evaluation and reporting of PT scheme results
7.4.1 Data analysis
7.4.2 Evaluation of performance
7.4.3 PT reports
7.5 Control of the PT scheme process
7.5.1 Technical records
7.5.2 Control of data and information management
7.5.3 Surveillance of the processes
7.5.4 Nonconforming work
7.6 Handling of complaints
7.7 Handling of appeals
8 Management system requirements
8.1 General requirements
8.2 Management system documentation
8.3 Control of management system documents
8.4 Control of records
8.5 Actions to address risks and opportunities
8.6 Improvement
8.7 Corrective actions
8.8 Internal audits
8.9 Management reviews
Annex A (informative) Types of PT schemes
Annex B (informative) Statistical methods for PT
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Impartiality
4.2 Confidentiality
5 Structural requirements
6 Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Externally provided products and services
7 Process requirements
7.1 Establishing, contracting and communicating the PT scheme objectives
7.1.1 Review of requests, tenders and contracts
7.1.2 PT scheme communication
7.2 Design and planning of a PT scheme
7.2.1 General
7.2.2 Statistical design
7.2.3 Determination of assigned values
7.3 Production and distribution of PT items
7.3.1 Production of PT items
7.3.2 Homogeneity and stability assessment of PT items
7.3.3 Handling and storage of PT items
7.3.4 Packaging, labelling and distribution of PT items
7.3.5 Instructions for participants
7.4 Evaluation and reporting of PT scheme results
7.4.1 Data analysis
7.4.2 Evaluation of performance
7.4.3 PT reports
7.5 Control of the PT scheme process
7.5.1 Technical records
7.5.2 Control of data and information management
7.5.3 Surveillance of the processes
7.5.4 Nonconforming work
7.6 Handling of complaints
7.7 Handling of appeals
8 Management system requirements
8.1 General requirements
8.2 Management system documentation
8.3 Control of management system documents
8.4 Control of records
8.5 Actions to address risks and opportunities
8.6 Improvement
8.7 Corrective actions
8.8 Internal audits
8.9 Management reviews
Annex A (informative) Types of PT schemes
Annex B (informative) Statistical methods for PT
Bibliography