ISO 17025 is an International Standard, used by testing and calibration laboratories, which 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.
This standard, ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It was produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced.
ISO 17025 contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results. The standard requires laboratories to demonstrate continual improvement, perform regular internal audits to identify opportunities to make the test or calibration better and it drives the laboratory to keep abreast of scientific and technological advances in relevant areas.
The use of this standard applies to all organizations performing tests and/or calibrations. These include, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO 17025 applies to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.
Laboratories that use this standard will be able to:
- Implement a quality system aimed at improving their ability to consistently produce valid results.
- Seek accreditation from an Accreditation Body.
- Demonstrate their customers and other interested parties that they are technically competent and able to produce precise and accurate test and/or calibration data.
- Operate in many countries where most labs must hold accreditation in order to be deemed technically competent. In many cases suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited.
This standard incorporates those ISO 9001 requirements that are relevant to the scope of testing and calibration services that are covered by the laboratory’s management system; therefore, all testing and calibration laboratories that comply with ISO 17025 will also operate in accordance with ISO 9001.
The following referenced documents are indispensable for the application of ISO 17025:
- ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
- VIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML.