ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
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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 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.2 Validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.8.1 General
7.8.2 Common requirements for reports (test, calibration or sampling)
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling – specific requirements
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
8 Management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Annex A (informative) Metrological traceability
Annex B (informative) Management system options
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 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.2 Validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.8.1 General
7.8.2 Common requirements for reports (test, calibration or sampling)
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling – specific requirements
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
8 Management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Annex A (informative) Metrological traceability
Annex B (informative) Management system options
Bibliography