Quality Management Systems for Calibration and Test Laboratories
ISO/IEC 17025:2005 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.
- The standards full title is “General Requirements for the Competence of Testing and Calibration Laboratories”;
- The current version is 17025:2005. The 2005 version does not suggest technical changes from the previous version; changes were to allow harmonization with ISO 9001:2008;
- If a testing and calibration laboratory complies with ISO 17025, it will also operate in accordance with ISO 9001. However, certification against ISO9001 does not itself demonstrate the competence of the laboratory to produce technically valid data and results;
- There is a discussion document ISO/IEC DIS 17025 to offer guidance on implementation;
- The standard can also covers in-house laboratories or testing operations where assurance of results is at a premium;
- It applies to organizations that want to assure their customers of precision, accuracy and repeatable results;
- It may be important to first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification;
- ISO/IEC 17025:2005 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 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply;
- Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories;
- ISO/IEC 17025 was formerly ISO Guide 25 & EN45001;
- Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005;
- ISO/TS 16949, the Automotive Quality Management System has stipulated that first tier suppliers of calibration and test services be ISO 17025 certified, and that suppliers upstream of them be compliant.