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===Gaps in ISO/IEC 17025=== | ===Gaps in ISO/IEC 17025=== | ||
It's important to note that ISO/IEC 17025 does not cover compliance with laboratory safety requirements.<ref name="WHOLQMS11">{{Cite web |last=World Health Organization |date=2011 |title=Laboratory Quality Management System: Handbook |url=http://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1 |format=PDF |publisher=World Health Organization |isbn=9789241548274}}</ref><ref>{{Cite journal |last=Pillai |first=Segaran |last2=Calvert |first2=Jennifer |last3=Fox |first3=Elizabeth |date=2022-11-03 |title=Practical considerations for laboratories: Implementing a holistic quality management system |url=https://www.frontiersin.org/articles/10.3389/fbioe.2022.1040103/full |journal=Frontiers in Bioengineering and Biotechnology |volume=10 |pages=1040103 |doi=10.3389/fbioe.2022.1040103 |issn=2296-4185 |pmc=PMC9670165 |pmid=36406233}}</ref> | It's important to note that ISO/IEC 17025 does not cover compliance with laboratory safety requirements.<ref name="WHOLQMS11">{{Cite web |last=World Health Organization |date=2011 |title=Laboratory Quality Management System: Handbook |url=http://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1 |format=PDF |publisher=World Health Organization |isbn=9789241548274}}</ref><ref>{{Cite journal |last=Pillai |first=Segaran |last2=Calvert |first2=Jennifer |last3=Fox |first3=Elizabeth |date=2022-11-03 |title=Practical considerations for laboratories: Implementing a holistic quality management system |url=https://www.frontiersin.org/articles/10.3389/fbioe.2022.1040103/full |journal=Frontiers in Bioengineering and Biotechnology |volume=10 |pages=1040103 |doi=10.3389/fbioe.2022.1040103 |issn=2296-4185 |pmc=PMC9670165 |pmid=36406233}}</ref> 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''<ref name="CLSIQMS01_19">{{cite web |url=https://clsi.org/standards/products/quality-management-systems/documents/qms01/ |title=QMS01 A Quality Management System Model for Laboratory Services, 5th Edition |publisher=Clinical and Laboratory Standards Institute |date=19 June 2019 |accessdate=18 December 2022}}</ref> and the [[World Health Organization]]'s (WHO's) ''Laboratory Quality Management System: Handbook''.<ref name="WHOLQMS11" /> (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."<ref name="WHOLQMS11" /> 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.<ref name="WHOLQMS11" /><ref name="CLSIQSE22">{{Cite web |last=Clinical and Laboratory Standards Institute |date=2022 |title=Quality System Essentials |url=https://clsi.org/standards-development/quality-system-essentials/ |publisher=Clinical and Laboratory Standards Institute}}</ref>) | ||
==Benefits of using ISO/IEC 17025== | ==Benefits of using ISO/IEC 17025== | ||
In its 2011 ''Laboratory Quality Management System: Handbook'', the | In its 2011 ''Laboratory Quality Management System: Handbook'', the WHO notes the following concerning the QMS model<ref name="WHOLQMS11" />: | ||
<blockquote>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.</blockquote> | <blockquote>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.</blockquote> | ||
Revision as of 20:27, 18 December 2022
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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])
Benefits of using 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.
Conclusion
References
- ↑ 1.0 1.1 1.2 1.3 1.4 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.
- ↑ 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/.
