|
|
| (37 intermediate revisions by the same user not shown) |
| Line 7: |
Line 7: |
|
| |
|
| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| [[File:Water quality testing in the lab (6f16fede-a75c-4444-af64-a339dff12012).JPG|right|200px]]
| |
| '''Title''': ''What types of laboratory testing are affected by ISO/IEC 17025?''
| |
| | |
| '''Author for citation''': Shawn E. Douglas
| |
| | |
| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
| |
| | |
| '''Publication date''': TBD
| |
| | |
| ==Introduction==
| |
| [[International Organization for Standardization]] (ISO)
| |
| | |
| | |
| ==Laboratories using ISO/IEC 17025==
| |
| | |
| The scope section of ISO/IEC 17025 indicates that the standard "is applicable to all organizations performing laboratory activities, regardless of the number of personnel." Further, in its terms and definitions section, the standard states that a laboratory—for the purposes of the document—is a "body that performs one or more of ... testing, calibration, [and] sampling, associated with subsequent testing or calibration." Of course, these types of activities occur in a wide variety of industry contexts, including environmental science, forensic science, food and beverage manufacturing, and more.
| |
| | |
| See [[Journal:Practical considerations for laboratories: Implementing a holistic quality management system]]
| |
| | |
| ===Testing laboratories (including regulatory laboratories)===
| |
| | |
| *radiological testing of food and drinking water<ref name="RaoISO21">{{Cite journal |last=Rao |first=Dd |date=2021 |title=ISO/IEC 17025: Accreditation standard for testing and calibration laboratories |url=http://www.rpe.org.in/text.asp?2021/44/3/121/334784 |journal=Radiation Protection and Environment |language=en |volume=44 |issue=3 |pages=121 |doi=10.4103/rpe.rpe_41_21 |issn=0972-0464}}</ref>
| |
| | |
| ===Product development and manufacturing labs===
| |
| | |
| | |
| ===Basic and applied research labs===
| |
| | |
| | |
| ===Reference measurement and calibration labs===
| |
| [[Reference laboratory]]
| |
| | |
| *radiation monitoring instruments<ref name="RaoISO21" />
| |
| | |
| | |
| ==A note about clinical laboratories==
| |
| You may notice that the [[clinical laboratory]] doesn't appear in the above listing. That is because quality management in the clinical lab is guided by [[ISO 15189|ISO 15189:2022]] ''Medical laboratories — Requirements for quality and competence''. The standard, which received an update in December 2022, is described by the ISO as being "applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies."<ref name="ISO15189_22">{{cite web |url=https://www.iso.org/standard/76677.html |title=ISO 15189:2022 Medical laboratories — Requirements for quality and competence |publisher=International Organization for Standardization |date=December 2022 |accessdate=23 December 2022}}</ref> Development of the standard began in the mid-1990s due to the lack of applicability ISO/IEC 17025 and [[ISO 9000|ISO 9001]] had to clinical labs. First published in February 2003, the standard was, however, developed with ISO/IEC 17025 and ISO 9001 in mind, taking the technical requirements of the first and the quality management requirements of the latter, while also adding input on professional requirements from the European Communities Confederation of Clinical Chemistry (EC4).<ref name="PlebaniISO15189_17">{{cite journal |last=Plebani |first=Mario |last2=Sciacovelli |first2=Laura |date=2017-09-01 |title=ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety |url=https://scindeks.ceon.rs/article.aspx?artid=1452-82581703225P |journal=Journal of Medical Biochemistry |volume=36 |issue=3 |pages=225–230 |doi=10.1515/jomb-2017-0038 |issn=1452-8266 |pmc=PMC6287216 |pmid=30564060}}</ref> All said, ISO 15189 is the best quality management standard for clinical laboratories as it takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to improving patient safety and outcomes.<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>
| |
| | |
| A potential companion to ISO 15189:2022 is the [[World Health Organization]]'s ''Laboratory Quality Management System: Handbook''. Though a bit outdated, as it was developed in 2011, the WHO handbook is based off of ISO 15189 and Clinical and Laboratory Standards Institute's (CLSI's) QMS01 ''A Quality Management System Model for Laboratory Services'' (or more specifically, its predecessor documents HS1 and GP26<ref name="ANSICLSIHS01">{{cite web| url=https://webstore.ansi.org/standards/clsi/clsihs01a2 |title=CLSI HS01-A2 |author=National Committee for Clinical Laboratory Standards |publisher=ANSI |date=November 2004}}</ref><ref name="ANSICLSIGP26">{{cite web| url=https://webstore.ansi.org/standards/clsi/clsigp26a3 |title=CLSI GP26-A3 |author=National Committee for Clinical Laboratory Standards |publisher=ANSI |date=November 2004}}</ref>).<ref name="WHOLQMS11" /> The WHO and CLSI tend to go beyond ISO/IEC 17025 by incorporating 12 quality system essentials (QSEs)—"a set of coordinated
| |
| activities that serve as building blocks for quality management"—as part of their QMS framework and emphasize that all must be met for overall clinical 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>
| |
| | |
| For more on this topic, see Plebani and Sciacovelli's "[[Journal:ISO 15189 accreditation: Navigation between quality management and patient safety|ISO 15189 accreditation: Navigation between quality management and patient safety]]."
| |
| | |
| | |
| ==Conclusion==
| |
| | |
| | |
| ==References==
| |
| {{Reflist|colwidth=30em}}
| |
| | |
| <!---Place all category tags here-->
| |
| [[Category:LIMS FAQ articles (added in 2022)]]
| |
| [[Category:LIMS FAQ articles (all)]]
| |
| [[Category:LIMS FAQ articles on ISO/IEC 17025]]
| |
