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 (25)
Audit
| Code | Title |
|---|---|
| 17025-8.8 | Internal Audits |
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 | General Requirements for Certification Bodies |
| 27006-5.2 | Management of 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 Records |
| 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 |
Complaints
| Code | Title |
|---|---|
| 17025-7.9 | Complaints |
Corrective Action
| Code | Title |
|---|---|
| 17025-8.7 | Corrective Action |
Data
| Code | Title |
|---|---|
| 17025-7.11 | Control of Data and Information Management |
General
| Code | Title |
|---|---|
| 17025-4.1 | Impartiality |
| 17025-4.2 | Confidentiality |
Improvement
| Code | Title |
|---|---|
| 17025-8.6 | Improvement |
Management
| Code | Title |
|---|---|
| 17025-8.2 | Management System Documentation |
Methods
| Code | Title |
|---|---|
| 17025-7.2 | Selection, Verification, Validation of Methods |
Nonconformity
| Code | Title |
|---|---|
| 17025-7.10 | Nonconforming Work |
Operations
| Code | Title |
|---|---|
| 17025-7.3 | Sampling |
| 17025-7.4 | Handling of Test and Calibration Items |
Process
| Code | Title |
|---|---|
| 17025-7.1 | Review of Requests, Tenders, Contracts |
Quality Control
| Code | Title |
|---|---|
| 17025-7.7 | Ensuring Validity of Results |
Records
| Code | Title |
|---|---|
| 17025-7.5 | Technical Records |
Reporting
| Code | Title |
|---|---|
| 17025-7.8 | Reporting of Results |
Resources
| Code | Title |
|---|---|
| 17025-6.2 | Personnel |
| 17025-6.3 | Facilities and Environmental Conditions |
| 17025-6.4 | Equipment |
| 17025-6.6 | Externally Provided Products and Services |
Review
| Code | Title |
|---|---|
| 17025-8.9 | Management Reviews |
Risk
| Code | Title |
|---|---|
| 17025-8.5 | Actions to Address Risks and Opportunities |
Structure
| Code | Title |
|---|---|
| 17025-5 | Structural Requirements |
Traceability
| Code | Title |
|---|---|
| 17025-6.5 | Metrological Traceability |
Uncertainty
| Code | Title |
|---|---|
| 17025-7.6 | Evaluation of Measurement Uncertainty |
Your Compliance Coverage
If you comply with ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories, you already cover:
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
13%
12 controls mapped
Compare →FDA Quality Management System Regulation (QMSR)
13%
12 controls mapped
Compare →PIC/S Guide to Good Manufacturing Practice for Medicinal Products
13%
12 controls mapped
Compare →+ 430 more: NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (12%), SWIFT CSCF (11%)
See all 433 mapped frameworks ↓Maps to 433 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 25 domains and 90 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 90 controls organised across 25 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 433 other compliance frameworks. The top mapping partners are ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (13% coverage), FDA Quality Management System Regulation (QMSR) (13% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (13% 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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