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Title: How does ISO/IEC 17025 impact laboratories?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: TBD
Introduction
What ISO/IEC 17025 asks of laboratories
Gaps in ISO/IEC 17025
It's important to note that ISO/IEC 17025 does not cover compliance with laboratory safety requirements.[1][2] Labs implementing the standard may very well want to reach out to other QMS frameworks to fill the gaps, for example, implementing the "Facilities and Safety" quality system essential (QSE) found in Clinical and Laboratory Standards Institute's (CLSI's) QMS01 A Quality Management System Model for Laboratory Services[3] and the World Health Organization's (WHO's) Laboratory Quality Management System: Handbook.[1] (A QSE, as defined by CLSI and WHO, is "a set of coordinated activities that serve as building blocks for quality management," with each needing to be "addressed if overall laboratory quality improvement is to be achieved."[1] Both organizations include 12 QSEs as part of their QMS framework and emphasize that all must be met for overall laboratory quality improvement to be realized.[1][4]) The "Facilities and Safety" QSE describes those elements that are essential to a laboratory's personnel, its design, and its safety in being able to prevent and control physical, chemical, and biological hazards from impacting operations. The WHO notes that addressing these elements through a laboratory safety program solidifies the lab's ability to provide quality data and services through protecting those in the lab, the facility, its equipment, and the work environment.[1]
Aside from safety, ISO/IEC 17025 has a few more minor gaps in how it addresses laboratory assessment tasks and personnel requirements when compared to the "Assessment" and "Personnel" QSEs of CLSI and WHO.[2] For example, the "Assessment" QSE addresses external audits whereas ISO/IEC 17025 does not, and the topics of proficiency testing and other external quality assessment methods is more rigorous in the "Assessment" QSE. Additionally, while ISO/IEC 17025 speaks of needing to document competence requirements for personnel, the "Personnel" QSE delves into greater detail of competency assessment methods, policy writing, procedure development, training, and performance appraisal. A lab implementing and accrediting to ISO/IEC 17025 may wish to further compare the nuances of these QSEs with the ISO standard as part of an effort to exceed the bare minimums of meeting ISO/IEC 17025 requirements.
Benefits of complying with ISO/IEC 17025
In its 2011 Laboratory Quality Management System: Handbook, the WHO notes the following concerning the QMS model[1]:
Laboratories not implementing a good quality management system are guaranteed that there will be many errors and problems occurring that may go undetected. Implementing a quality management system may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring.
Complying with and accrediting to ISO/IEC 17025 has numerous benefits as it[5]:
- demonstrates conformance to an international standard that in turn expands laboratory access to global markets
- demonstrates objectively, through accreditation, provision of quality and technically competent services
- aids in controlling costs, improving measurement accuracy, and reducing waste
- ensures specific quality levels and customer needs are satisfied
Conclusion
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 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 Pillai, Segaran; Calvert, Jennifer; Fox, Elizabeth (3 November 2022). "Practical considerations for laboratories: Implementing a holistic quality management system". Frontiers in Bioengineering and Biotechnology 10: 1040103. doi:10.3389/fbioe.2022.1040103. ISSN 2296-4185. PMC PMC9670165. PMID 36406233. https://www.frontiersin.org/articles/10.3389/fbioe.2022.1040103/full.
- ↑ "QMS01 A Quality Management System Model for Laboratory Services, 5th Edition". Clinical and Laboratory Standards Institute. 19 June 2019. https://clsi.org/standards/products/quality-management-systems/documents/qms01/. Retrieved 18 December 2022.
- ↑ Clinical and Laboratory Standards Institute (2022). "Quality System Essentials". Clinical and Laboratory Standards Institute. https://clsi.org/standards-development/quality-system-essentials/.
- ↑ 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.
