1.1 This Standard 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.
1.2 This Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
This Standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by this Standard, such as sampling and the design/development of new methods, the requirements of those Chapters do not apply.
1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this Standard.
1.4 This Standard is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This Standard is not intended to be used as the basis for certification of laboratories.
Note 1: The term 'management system' in this Standard means the quality, administrative and technical systems that govern the operations of a laboratory.
Note 2: Certification of a management system is sometimes also called registration.
1.5 Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this Standard.
1.6 If testing and calibration laboratories comply with the requirements of this Standard, they will operate a quality management system for their testing and calibration activities that also meets the principles of GB/T 19001. Appendix A provides nominal cross-references between this Standard and GB/T 19001. This Standard covers technical competence requirements that are not covered by GB/T 19001.
Note 1: It might be necessary to explain or interpret certain requirements in this Standard to ensure that the requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially for accreditation bodies (see GB/T 27011) is given in Appendix B.
Note 2: If a laboratory wishes accreditation for part or all of its testing and calibration activities, it should select an accreditation body that operates in accordance with GB/T 27011.
Foreword II
Introduction III
1 Scope
2 Normative References
3 Terms and Definitions
4 Management Requirements
4.1 Organization
4.2 Management system
4.3 Document control
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
4.12 Preventive action
4.13 Control of 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
5.5 Equipment
5.6 Measurement traceability
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
Appendix A (Informative) Nominal Cross-references to GB/T 19001-
Appendix B (Informative) Guidelines for Establishing Applications for Specific Fields
Bibliography
