ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It is the basis for laboratory accreditation worldwide. Applicable to all laboratories regardless of the number of personnel or scope of activities. Covers structural requirements, resource requirements, process requirements, and management system requirements. Over 80,000 accredited laboratories globally. Accreditation by national bodies (UKAS, NATA, A2LA, etc.) under the ILAC Mutual Recognition Arrangement.
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Framework Domains (5)
Clause 4: General Requirements
| Code | Title |
|---|---|
| ISO-15189-4.1 | Impartiality |
| ISO-15189-4.2 | Confidentiality |
| ISO-15189-4.3 | Requirements regarding patients |
| ISO-17025-4.1 | Impartiality |
| ISO-17025-4.2 | Confidentiality |
Clause 5: Structural Requirements
| Code | Title |
|---|---|
| 27006-5.1 | Organizational structure |
| 27006-5.2 | Independence and impartiality |
| ISO-17025-5.1 | Legal entity |
| ISO-17025-5.2 | Management structure |
| ISO-17025-5.3 | Range of laboratory activities |
| ISO-17025-5.4 | Personnel for the management system |
| ISO-17025-5.5 | Independence of quality functions |
Clause 6: Resource Requirements
| Code | Title |
|---|---|
| 27006-6.1 | Competence of personnel |
| 27006-6.2 | Personnel involved in certification |
| ISO-15189-6.1 | General |
| ISO-15189-6.2 | Personnel |
| ISO-15189-6.3 | Facilities and environmental conditions |
| ISO-15189-6.4 | Equipment |
| ISO-15189-6.5 | Equipment calibration and metrological traceability |
| ISO-15189-6.6 | Reagents and consumables |
| ISO-15189-6.7 | Service agreements |
| ISO-15189-6.8 | Externally provided products and services |
| ISO-17025-6.1 | General |
| ISO-17025-6.2 | Personnel |
| ISO-17025-6.3 | Facilities and environmental conditions |
| ISO-17025-6.4 | Equipment |
| ISO-17025-6.5 | Metrological traceability |
| ISO-17025-6.6 | Externally provided products and services |
Clause 7: Process Requirements
| Code | Title |
|---|---|
| ISO-15189-7.1 | General |
| ISO-15189-7.2 | Pre-examination processes |
| ISO-15189-7.3 | Examination processes |
| ISO-15189-7.4 | Post-examination processes |
| ISO-15189-7.5 | Nonconforming work |
| ISO-15189-7.6 | Data and information management |
| ISO-15189-7.7 | Complaints |
| ISO-15189-7.8 | Continuity and emergency preparedness |
| ISO-17025-7.1 | Review of requests, tenders and contracts |
| ISO-17025-7.10 | Nonconforming work |
| ISO-17025-7.11 | Control of data and information management |
| ISO-17025-7.2 | Selection, verification and validation of methods |
| ISO-17025-7.3 | Sampling |
| ISO-17025-7.4 | Handling of test or calibration items |
| ISO-17025-7.5 | Technical records |
| ISO-17025-7.6 | Evaluation of measurement uncertainty |
| ISO-17025-7.7 | Ensuring the validity of results |
| ISO-17025-7.8 | Reporting of results |
| ISO-17025-7.9 | Complaints |
Clause 8: Management System Requirements
| Code | Title |
|---|---|
| ISO-15189-8.1 | General requirements |
| ISO-15189-8.2 | Management system documentation |
| ISO-15189-8.3 | Control of documents |
| ISO-15189-8.4 | Control of records |
| ISO-15189-8.5 | Actions addressing risks and opportunities |
| ISO-15189-8.6 | Improvement |
| ISO-15189-8.7 | Nonconformities and corrective actions |
| ISO-15189-8.8 | Evaluations |
| ISO-15189-8.9 | Management reviews |
| ISO-17025-8.1 | Options |
| ISO-17025-8.2 | Management system documentation |
| ISO-17025-8.3 | Control of management system documents |
| ISO-17025-8.4 | Control of records |
| ISO-17025-8.5 | Actions to address risks and opportunities |
| ISO-17025-8.6 | Improvement |
| ISO-17025-8.7 | Corrective actions |
| ISO-17025-8.8 | Internal audits |
| ISO-17025-8.9 | Management reviews |
Maps to 521 other frameworks
Frequently Asked Questions
What is ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories is a compliance framework from International (ISO/IEC) with 5 domains and 65 controls. ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It is the basis for laboratory accreditation worldwide. Applicable to all laboratories regardless of the number of personnel or scope of activities. Covers structural requirements, resource requirements, process requirements, and management system requirements. Over 80,000 accredited laboratories globally. Accreditation by national bodies (UKAS, NATA, A2LA, etc.) under the ILAC Mutual Recognition Arrangement. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories have?
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories has 65 controls organised across 5 domains. The largest domains are Clause 7: Process Requirements (19 controls), Clause 8: Management System Requirements (18 controls), Clause 6: Resource Requirements (16 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories map to?
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories maps to 521 other compliance frameworks. The top mapping partners are FDA Quality Management System Regulation (QMSR) (18% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (18% coverage), NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements (17% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories compliance?
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