General requirements for testing and calibration laboratory capabilities

1 Scope
1.1 This standard specifies the general requirements for the laboratory's ability to perform testing and / or calibration (including sampling ability). These tests and calibrations include tests and calibrations using standard methods, non-standard methods, and laboratory-developed methods.
1.2 This standard applies to all organizations engaged in testing and / or calibration, including laboratories such as first-party, second-party, and third-party laboratories, and laboratories that use testing and / or calibration as part of inspection and product certification.
This standard applies to all laboratories, regardless of the number of personnel or the size of testing and / or calibration activities. When the laboratory is not engaged in one or more activities included in this standard, such as sampling and design (development) of new methods, the requirements of the relevant clauses of this standard may not be used.
1.3 The notes in the text are explanations, examples and guidance for the text. It neither contains requirements nor constitutes the main part of this standard.
1.4 This standard is used by laboratories to establish quality, management and technical systems and control their actions. Laboratory customers, statutory regulatory agencies and accreditation bodies can also use this standard to confirm or recognize the capabilities of the laboratory.
1.5 This standard does not include regulations and safety requirements that should be met during laboratory operations.
1.6 If testing and calibration laboratories meet the requirements of this standard, when they are engaged in the design (development) of new methods and / or work plans in conjunction with standard and non-standard testing and calibration methods, their testing and calibration operations The quality system also meets the requirements of GB / T19001 (idt ISO 9001); when the laboratory only uses standard methods, it complies with the requirements of GB / T19002 (idt ISO 9002). This standard contains some technical capability requirements not included in GB / T 19001 (idt ISO 9001) and GB / T 19002 (idt ISO 9002). Appendix A provides a comparison of the terms of ISO / IEC 17025 and ISO 9001 and ISO 9002.
Note 1: In order to ensure the consistency of the application of these requirements, it may be necessary to explain or explain some of the requirements of this standard. Appendix B gives guidelines for formulating application rules in special fields, especially for accreditation bodies (see GB / T15486-1996 (idtISO / IEC Guide 58: 1993, 4.1.3).
Note 2: If the laboratory wishes to approve its part or testing and calibration activities, it should choose an accreditation body that acts according to GB / T15486-1996 (idtISO / IEC Guide 58).

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