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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
History of ISO/IEC 17025
ISO/IEC 17025's origins go back to the mid-1970s, when a conference on cross-border acceptance of test data led to the International Laboratory Accreditation Cooperation (ILAC) beginning work on what would eventually become ISO Guide 25 Guidelines for assessing the technical competence of testing laboratories, after turning the work over to the International Organization for Standardization (ISO). The intent of developing the guide, published in 1978, was to gain international cooperation towards improving the world's laboratory services by promoting a scheme for accredited laboratory test results, such that the results could be more readily accepted across national borders.[1][2][3] That first guide didn't address the activities of calibration labs, however, and it would require further revisions, as the general guidelines towards proving a lab's technical competence were also inadequate.[2] For the next version, released in 1982 as ISO/IEC Guide 25: General requirements for the technical competence of testing laboratories, the International Electrotechnical Commission (IEC) became involved. That version saw upgrades in proving technical competence, as well as the addition of the requirement for a quality system, though it too didn't address calibration labs.[2] The next version, released in 1990 as ISO/IEC Guide 25 General requirements for the competence of calibration and testing laboratories, finally addressed calibration labs and, with the help of the Council Committee on Conformity Assessment (CASCO), lent "support for national systems, thus easing bilateral agreements" associated with laboratory testing.[1][2][3] It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the ISO 9000 standard. Four years later, CASCO pushed to turn ISO/IEC Guide 25 into a full standard, and by 1999, ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories was born, which also met the requirements of ISO 90001.[1][2][3]
Since then, the standard has seen two additional revisions, one in 2005 and another in 2017.[1][2][3] With the ISO 9001 standard in revision at the same time as ISO/IEC 17025:1999, the standard's take on ISO 9001 when published was antiquated, requiring the 2005 update.[2] The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from it 2005 predecessor. (For more on the differences between the 2005 and 2017 version, see the National Association of Testing Authorities' (NATA's) gap analysis document comparing the two.[4])
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.[5]
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."[6] 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."[6]
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.[5] 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 1.2 1.3 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.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 Miguel, Anna; Moreira, Renata; Oliveira, André (2021). "ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS". Química Nova. doi:10.21577/0100-4042.20170726. http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf.
- ↑ 3.0 3.1 3.2 3.3 Vehring, S. (June 2020). "Tested & Accepted: Implementing ISO/IEC 17025:2017" (PDF). United Nations Industrial Development Organization. https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf. Retrieved 18 December 2022.
- ↑ National Association of Testing Authorities (April 2018). "General Accreditation Guidance: ISO/IEC 17025:2017 Gap analysis" (PDF). https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf. Retrieved 21 Decemeber 2022.
- ↑ 5.0 5.1 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.
- ↑ 6.0 6.1 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.
