ISO/IEC 17025

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General requirements for the competence of testing and calibration laboratories

The first edition of ISO 17025:1999 cancelled and replaced ISO Guide 25 and EN 45001. This standard has all of the requirements that testing and calibration laboratories have to meet in order to demonstrate that:

• they operate a quality system,
• are technically competent,
• and are able to produce technically valid results.

Accreditation bodies use ISO 17025 as the basis for their accreditation of laboratories and test houses. The Standard was updated again in 2005 (ISO/IEC 17025:2005)

While the ISO 9000 requirements are generic and are intended to be applicable to any type of organisation, the ISO 17025 requirements are specific to testing and calibration laboratories. This standard addresses issues such as: the technical competence of personnel, ethical behaviour of staff, use of well-defined test and calibration procedures, participation in proficiency testing, and contents of test reports and certificates.

Another reason for development of the standard was to harmonise laboratory accreditation and acceptance of test data worldwide. All participating countries will be required to accept the test results performed by accredited members of these other countries.

Other quality systems (such as ISO TS 16949 in the automotive industry) require suppliers to meet ISO 17025 in their own or subcontracted laboratory services.