ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999 and revised in the year 2005.
ISO 17025 was developed so that testing & calibration laboratories were recognized for their capabilities & areas of competence. All measurements and decisions should be based on accurate, repeatable, verifiable, cost effective, timely, and believable measurements, opinions, and recommendations. ISO 17025 helps assures this happens first time, every time, and on-time.
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.
ISO/IEC 17025:2017 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 ISO/IEC 17025:2017, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
This international standard has been produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it now replaced. It contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent , and are able to generate technically valid results.
Accreditation bodies that recognize the competence of testing and calibration laboratories should use this international standard as the basis for their accreditation. Clause 4 specified the requirements for sound Management and clause 5 specified the requirements for technical competence for the type of tests and/or calibrations the laboratory undertakes.
ISO/IEC 17025:2017 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.
The contents of ISO/IEC 17025 - The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an Accreditation Body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
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