ISO/IEC 17043:2023
The accreditation standard for proficiency testing providers: impartiality and confidentiality, legal and organisational structure, competent personnel and controlled external providers, contract review and scheme communication, scheme planning with statistical design and assigned values, PT item production, homogeneity and stability, distribution and participant instructions, data analysis, performance evaluation and reporting, records, information systems, surveillance, nonconforming work, complaints and appeals, and the management system that holds it together.
ISO/IEC 17043:2023 is a compliance framework from International with 6 domains and 35 controls. The largest domains are Clause 7.1 to 7.3: Scheme objectives, design and PT items – ISO/IEC 17043:2023 (10 controls), Clause 7.4 to 7.7: Evaluation, reporting, process control, complaints and appeals – ISO/IEC 17043:2023 (9 controls), Clause 8: Management system requirements – ISO/IEC 17043:2023 (8 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (6)
Clause 4: General requirements (impartiality, confidentiality) – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::4.1 | Undertake PT activities impartially and manage threats to impartiality |
| iso-iec-17043-2023::4.2 | Keep information from PT activities confidential under enforceable agreements |
Clause 5: Structural requirements – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::5.1-5.4 | Be a legally responsible entity with defined management, declared schemes and consistent operation at every site |
| iso-iec-17043-2023::5.5-5.7 | Define the organisation, personnel authority and management communication |
Clause 6: Resource requirements – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::6.1 | Hold the resources needed and run characterisation and reference material work to the relevant standards |
| iso-iec-17043-2023::6.2 | Ensure competent, impartial and authorised personnel |
| iso-iec-17043-2023::6.3 | Provide suitable facilities and controlled environmental conditions |
| iso-iec-17043-2023::6.4 | Control externally provided products and services and never outsource design, evaluation or report authorisation |
Clause 7.1 to 7.3: Scheme objectives, design and PT items – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::7.1.1 | Review requests, tenders and contracts for each scheme |
| iso-iec-17043-2023::7.1.2 | Communicate scheme details and changes to participants and customers |
| iso-iec-17043-2023::7.2.1 | Plan each scheme in a documented plan before it starts and manage the risk of significant change |
| iso-iec-17043-2023::7.2.2 | Develop and document a statistical design fit for the scheme's objectives |
| iso-iec-17043-2023::7.2.3 | Determine assigned values with documented procedure, traceability, uncertainty and a disclosure policy |
| iso-iec-17043-2023::7.3.1 | Produce PT items to plan and control their selection, preparation, handling, storage and disposal |
| iso-iec-17043-2023::7.3.2 | Assess homogeneity and stability of PT items every round against risk-based criteria |
| iso-iec-17043-2023::7.3.3 | Identify, store and check PT items from production to distribution, with safe handling of hazardous items |
| iso-iec-17043-2023::7.3.4 | Control packaging, labelling, transport conditions and delivery confirmation |
| iso-iec-17043-2023::7.3.5 | Give participants notice and detailed documented instructions |
Clause 7.4 to 7.7: Evaluation, reporting, process control, complaints and appeals – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::7.4.1 | Record and analyse results with validated data handling, outlier control and documented exclusions |
| iso-iec-17043-2023::7.4.2 | Evaluate performance with valid documented methods and expert commentary |
| iso-iec-17043-2023::7.4.3 | Issue clear, complete and timely PT reports and control their amendment and use |
| iso-iec-17043-2023::7.5.1 | Keep technical records that allow repetition and trace every amendment |
| iso-iec-17043-2023::7.5.2 | Validate, protect and control the information management system |
| iso-iec-17043-2023::7.5.3 | Plan and review surveillance of the scheme processes |
| iso-iec-17043-2023::7.5.4 | Manage nonconforming work with defined authorities, risk-based actions and recall |
| iso-iec-17043-2023::7.6 | Handle complaints through a public, impartial and documented process |
| iso-iec-17043-2023::7.7 | Handle appeals through a public, impartial and documented process |
Clause 8: Management system requirements – ISO/IEC 17043:2023
| Code | Title |
|---|---|
| iso-iec-17043-2023::8.1-8.2 | Establish a management system with the required elements, committed management and accessible documentation |
| iso-iec-17043-2023::8.3 | Control internal and external management system documents |
| iso-iec-17043-2023::8.4 | Control records for identification, protection, retention and access |
| iso-iec-17043-2023::8.5 | Address risks and opportunities in proportion to their effect on scheme validity |
| iso-iec-17043-2023::8.6 | Identify improvement opportunities and use participant and customer feedback |
| iso-iec-17043-2023::8.7 | React to nonconformities with cause analysis, proportionate corrective action and records |
| iso-iec-17043-2023::8.8 | Conduct internal audits under a planned, independent programme |
| iso-iec-17043-2023::8.9 | Review the management system at planned intervals with the required inputs and recorded outputs |
What is ISO/IEC 17043:2023 and who does it apply to?
ISO/IEC 17043:2023 is a compliance framework from International with 6 domains and 35 controls. The accreditation standard for proficiency testing providers: impartiality and confidentiality, legal and organisational structure, competent personnel and controlled external providers, contract review and scheme communication, scheme planning with statistical design and assigned values, PT item production, homogeneity and stability, distribution and participant instructions, data analysis, performance evaluation and reporting, records, information systems, surveillance, nonconforming work, complaints and appeals, and the management system that holds it together. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ISO/IEC 17043:2023 actually require?
ISO/IEC 17043:2023 has 35 controls organised across 6 domains. The largest domains are Clause 7.1 to 7.3: Scheme objectives, design and PT items – ISO/IEC 17043:2023 (10 controls), Clause 7.4 to 7.7: Evaluation, reporting, process control, complaints and appeals – ISO/IEC 17043:2023 (9 controls), Clause 8: Management system requirements – ISO/IEC 17043:2023 (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ISO/IEC 17043:2023 do I already cover?
ISO/IEC 17043:2023 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ISO/IEC 17043:2023?
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