ISO 17025 incorporates all the ISO 9001 requirements that are relevant to the scope of testing and calibration services. They specify the technical requirements for technical competence. ISO/IEC 17025 focuses on the laboratory competence to carry out tests and/or calibrations. This provides guidance to owners and operators of laboratories on both quality management in a laboratory environment and technical requirements for the proper operation of a testing laboratory.
ISO/IEC 17025:2005, covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It 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. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 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. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.
The standard is widely used as a quality system in environmental, food, chemical and clinical testing laboratories.
