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Title: What is the importance of ISO/IEC 17025 to society?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: TBD
Introduction
"ISO/IEC 17025 specifies general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration quality systems using standard methods and laboratory-developed or modified methods.
The standard consists of general, structural, resource, process, and management system requirements. The general, structural, and management system requirements relate primarily to the operation and effectiveness of the laboratory’s quality management system and the laboratory organization itself. The resource and process requirements include factors that determine the correctness and reliability of the tests and calibrations the laboratory conducts." - https://anab.ansi.org/laboratory-accreditation/iso-iec-17025
History of ISO/IEC 17025
- https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf
- https://www.scielo.br/j/qn/a/3gwbfvVs8qydVd5ZstwXCph/?lang=en
- Squirrell, A. (1 September 2008). "Conformity assessment: providing confidence in testing and calibration" (in en). Accreditation and Quality Assurance 13 (9): 543–546. doi:10.1007/s00769-008-0418-2. ISSN 0949-1775. http://link.springer.com/10.1007/s00769-008-0418-2.
Quality management is defined by ISO 9000 as a set of "coordinated activities to direct and control an organization with regard to quality.” By extension, those coordinated activities require sufficient "organizational structure, resources, processes and procedures" in order to implement quality management throughout the enterprise, otherwise known as a quality system.[1]
As laboratory consultancy Perry Johnson Consulting notes, the difference between the ISO/IEC 17025 standard and ISO 9001:2015 can be found in comparing the accreditation process: "ISO/IEC 17025:2017 accreditation is recognition of a laboratory’s competence to produce technically valid results, while ISO 9001:2015 registration of a laboratory is limited to QMS conformance."[2] They add that ISO/IEC 17025:2017's "technical competency requirements go beyond QMS registration and relate specifically to the qualifications needed with regard to personnel, equipment, facilities, and laboratory methods."[2]
How supporting quality management in the laboratory improves society
"Quality management is as applicable for the medical laboratory as it is for manufacturing and industry," states the World Health Organization (WHO) in its 2011 Laboratory Quality Management System: Handbook.[1] While the medical laboratory is better covered by ISO 15189, the WHO's statement highlights that all laboratories can benefit from implementing quality management principles.
Conclusion
References
- ↑ 1.0 1.1 World Health Organization (2011). "Laboratory Quality Management System: Handbook" (PDF). World Health Organization. ISBN 9789241548274. http://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1.
- ↑ 2.0 2.1 Perry Johnson Consulting, Inc (January 2022). "ISO/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview" (PDF). https://www.pjcinc.com/Downloads/ISOIEC17025_exov.pdf. Retrieved 18 December 2022.
