General Requirements for the Competence of Testing and Calibration Laboratories
1.1 This International 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 International 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 International 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 International Standard, such as sampling and the design/development of new methods, the requirements of those clauses 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 International Standard.
1.4 This International 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 International Standard is not intended to be used as the basis for certification of laboratories.
NOTE 1 The term 'management system' in this International 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 International Standard.
1.6 If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001. Annex A provides nominal cross-references between this International Standard and ISO 9001. This International Standard covers technical competence requirements that are not covered by ISO 9001.
NOTE 1 It might be necessary to explain or interpret certain requirements in this International Standard to ensure that the requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially for accreditation bodies (see ISO/IEC 17011) is given in Annex 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 ISO/IEC 17011.
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