Book:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Introduction to ISO/IEC 17025/History of ISO/IEC 17025
1. Introduction to ISO/IEC 17025
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ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is an internationally recognized standard that places requirements on testing, calibration, and sampling laboratories to demonstrate "the competence, impartiality, and consistent operation" of their business activities.[1] At its core, the standard places a strong focus on implementing procedural and quality management mechanisms as a means towards meeting those goals. ISO/IEC 17025 has a long history that dates back to a time when international trade in the 1970s saw Japan leading the charge with its total quality efforts, driven by the desire to rebuild shattered industries after World War II. Japanese products just couldn't compete with the quality of other industrialized nations, and the Japanese clamored for something better. That focus on total quality eventually spread Westward in the 1980s.[2][3] To this day, this desire for higher-quality goods and services by customers, clients, and other stakeholders continues to drive innovation and expansion in industry. Such is the path with quality, a trait demanded by and benefiting society in many ways.
The ISO/IEC 17025 standard is one of a few standards that focuses on managing quality in the organization, yet it goes beyond standards like ISO 9001 by not only encouraging use of a quality system (i.e., a quality management system or QMS) but also setting standards of unbiased operational competence and consistency. The standard also is clear in its audience: testing, calibration, and sapling labs. Not all labs choose to adopt the standard, but those that do tend to find it rewarding, if not also a bit challenging.
The rest of this chapter will examine the ISO/IEC 17025 standard and its origins, and how it compares to standards like ISO 9001. It will also address how those labs choosing to embrace the standard provide a net benefit to society as a whole.
1.1 History of ISO/IEC 17025
ISO/IEC 17025's origins go back to the mid-1970s, when a conference on cross-border acceptance of laboratory 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, with that work ultimately getting turned 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.[4][5][6] 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.[5] 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 this revision also didn't address calibration labs.[5] 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.[4][5][6] It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the ISO 9000 standard, which also focused on quality. 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 9001.[4][5][6]
Since then, the standard has seen two additional revisions, one in 2005 and another in 2017.[4][5][6] With the ISO 9001 standard being in revision at the same time ISO/IEC 17025:1999 was ready to release, the standard's views on ISO 9001 when published were antiquated, requiring the 2005 update.[5] The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from its 2005 predecessor, with the 2005 division between technical management and quality management being replaced by "a more unified focus on a laboratory's general responsibility management."[5] (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.[7]) As of January 2023, ISO/IEC 17025:2017 remains the latest version of the standard, putting a focus on labs seeking competent, impartial, and consistent results, with a focus on an efficient management system (i.e., a QMS).
References
- ↑ "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 11 February 2023.
- ↑ "Total Quality". Learn About Quality. American Society for Quality. https://asq.org/quality-resources/history-of-quality#development. Retrieved 11 February 2023.
- ↑ "Total quality management: myth or miracle?" (in en). Total Quality Management 4 (4): 5–8. 1 January 1993. doi:10.1080/09544129300000048. ISSN 0954-4127. http://www.tandfonline.com/doi/abs/10.1080/09544129300000048.
- ↑ 4.0 4.1 4.2 4.3 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.
- ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 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.
- ↑ 6.0 6.1 6.2 6.3 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 11 February 2023.
- ↑ 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 11 February 2023.
