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ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which 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. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles.[1] Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.[2] Material in the standard also forms the basis for accreditation from an accreditation body.
There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. The 2005 release also aligned more closely with the 2000 version of ISO 9001 with regards to implementing continuous improvement.[3]
The 2005 version of the standard comprises four elements:
- Normative References
- Terms and Definitions
- Management Requirements - related to the operation and effectiveness of the quality management system within the laboratory
- Technical Requirements - factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.
The 2017 version comprises eight elements:
- Scope
- Normative References
- Terms and Definitions
- General Requirements - related to the organization of the laboratory
- Structural Requirements -related to the organization of the laboratory
- Resource Requirements - cites issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results
- Process Requirements - the heart of this version of the standard describes the activities to ensure that results are based on accepted science and aimed at technical validity.
- Management System Requirements -steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results
- ^ "Principles behind ISO/IEC 17025" (PDF). Canadian Association for Laboratory Accreditation (CALA). Archived from the original (PDF) on 11 August 2019. Retrieved 27 March 2018.
- ^ Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". Journal of AOAC International. 86 (5): 1038–1044. doi:10.1093/jaoac/86.5.1038. PMID 14632407. Retrieved 28 February 2012.
- ^ "ISO/IEC 17025 Comparison - 1999 to 2005". SAI Global Limited ABN. Archived from the original on 2011-04-10. Retrieved 28 February 2012.