BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.
BS EN ISO/IEC 17025 is the standard that specifies the general requirements for the competence of laboratories 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.
BS EN ISO/IEC 17025 applies 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.
BS EN ISO/IEC 17025 also applies 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 BS EN ISO/IEC 17025, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO17025 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.
BS EN ISO/IEC 17025 is not intended to be used as the basis for certification of laboratories.
BS EN ISO/IEC 17025:2005 supersedes BS EN ISO/IEC 17025:2000 which has been withdrawn.
BS EN ISO/IEC 17025 covers technical competence requirements that are not covered by ISO 9001.
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.
ISO Guide 34 (in conjunction with ISO/IEC 17025) is the definitive standard for reference material production used by accreditation bodies (such as UKAS) and the CIPM* world-wide. It describes the fundamental quality system and technical requirements to produce reference materials (RMs) and certified reference materials (CRMs) at the highest level. ISO Guide 34 is supported by ISO Guides 30, 31, 33 and 35. These guides are used as references to ISO Guide 34, and these all should be read in conjunction with each other.
UKAS operate an accreditation scheme to ISO Guide 34, and UKAS-accredited testing laboratories should be using either ISO Guide 34 or ISO 17025 accredited certified reference materials wherever possible. Once UKAS accredit a lab with ISO Guide 34, the reference material producer is competent to manufacture CRM’s, and is able self-certify these products. Therefore, more products can be offered under this scheme so long as they are manufactured in accordance with the Guide. In addition newly accredited products require less administration by the accrediting body so can be brought to market in a shorter time-scale.