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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| [[File:Hohenstein Quality Testing.jpg|right|300px]]
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| '''Title''': ''How does ISO/IEC 17025 impact laboratories?''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': TBD
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| ==Introduction==
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| ==What ISO/IEC 17025 asks of laboratories==
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| ===Gaps in ISO/IEC 17025===
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| 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 name="PillaiPract22">{{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>) 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.<ref name="WHOLQMS11" />
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| 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.<ref name="PillaiPract22" /> 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.
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| ==Benefits of complying with ISO/IEC 17025==
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| In its 2011 ''Laboratory Quality Management System: Handbook'', the WHO notes the following concerning the QMS model<ref name="WHOLQMS11" />:
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| <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>
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| Complying with and accrediting to ISO/IEC 17025 has numerous benefits as it<ref name="PJC17025_22">{{cite web |url=https://www.pjcinc.com/Downloads/ISOIEC17025_exov.pdf |format=PDF |title=ISO/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview |author=Perry Johnson Consulting, Inc |date=January 2022 |accessdate=18 December 2022}}</ref>:
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| * demonstrates conformance to an international standard that in turn expands laboratory access to global markets
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| * demonstrates objectively, through accreditation, provision of quality and technically competent services
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| * aids in controlling costs, improving measurement accuracy, and reducing waste
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| * ensures specific quality levels and customer needs are satisfied
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| ==Conclusion==
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| ==References==
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| {{Reflist|colwidth=30em}}
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| <!---Place all category tags here-->
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| [[Category:LIMS FAQ articles (added in 2022)]]
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| [[Category:LIMS FAQ articles (all)]]
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| [[Category:LIMS FAQ articles on ISO/IEC 17025]]
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