Table of Contents
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization
4.2 Management system
4.3 Document control
4.3.1 General
4.3.2 Document approval and issue
4.3.3 Document changes
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.11.1 General
4.11.2 Cause analysis
4.11.3 Selection and implementation of corrective actions
4.11.4 Monitoring of corrective actions
4.11.5 Additional audits
4.12 Preventive action
4.13 Control of records
4.13.1 General
4.13.2 Technical records
4.14 Internal audits
4.15 Management reviews
5 Technical requirements
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.4.1 General
5.4.2 Selection of methods
5.4.3 Laboratory-developed methods
5.4.4 Non-standard methods
5.4.5 Validation of methods
5.4.6 Estimation of uncertainty of measurement
5.4.7 Control of data
5.5 Equipment
5.6 Measurement traceability
5.6.1 General
5.6.2 Specific requirements
5.6.3 Reference standards and reference materials
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
5.10.1 General
5.10.2 Test reports and calibration certificates
5.10.3 Test reports
5.10.4 Calibration certificates
5.10.5 Opinions and interpretations
5.10.6 Testing and calibration results obtained from
subcontractors
5.10.7 Electronic transmission of results
5.10.8 Format of reports and certificates
5.10.9 Amendments to test reports and calibration certificates
Annex A (informative) Nominal cross-references to ISO 9001:2000
Annex B (informative) Guidelines for establishing applications for
specific fields
Bibliography
Abstract
Specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
History
First published as HB 18.25:1991.
Revised and redesignated as AS ISO/IEC 17025-1999.
Second edition 2005.