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| [[File:Water quality testing in the lab (6f16fede-a75c-4444-af64-a339dff12012).JPG|right|250px]]
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| '''Title''': ''What types of laboratory testing are affected by ISO/IEC 17025?''
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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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| [[International Organization for Standardization]] (ISO)
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| ==Laboratories using ISO/IEC 17025==
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| ISO/IEC 17025:2017 is an international standard that dictates how a laboratory demonstrates "competence, impartiality, and consistent operation" in all of its activities.<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=23 December 2022}}</ref> 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."<ref name="ISO17025_17" /> 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."<ref name="ISO17025_17" /> Of course, when it comes to testing, calibration, and sampling, these types of activities occur in a wide variety of industry contexts, including but not limited to environmental science, forensic science, food and beverage manufacturing, agricultural research, and pharmaceutical manufacturing.
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| The following subsections provide background on the different laboratory operations affected by ISO/IEC 17025 and give examples of ISO/IEC 17025-accredited activities, research topics, or calibration targets noted in academic literature. These subdivisions of labs are, in part, influenced by the work of Pillai ''et al.'' (though they largely fail to address calibration and reference testing labs in their work; these labs are added here).<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>
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| ===Analytical and regulatory testing labs===
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| These types of labs conduct analytical tests on a wide variety of substances, materials, and equipment to ensure they are safe, effective, and secure for their application. Often times that testing is being performed due to a [[Regulatory compliance|regulatory mandate]] concering safety and efficacy.<ref name="PillaiPract22" /> Manufacturers of all types of consumables and consumer use products (e.g., pharamaceuticals, foods, and cosmetics) will turn to in-house or third-party analytical and regulatory testing laboratories to perform the recommended or mandated analyses on their products to ensure their quality and safety.<ref name="PillaiPract22" /> Additionally, federal, state, and local governments also have to follow regulations concerning frequent testing of municipal infrastructure, including water, wastewater, and construction activities.<ref name="EPAWater22">{{cite web |url=https://www.epa.gov/regulatory-information-topic/regulatory-and-guidance-information-topic-water |title=Regulatory and Guidance Information by Topic: Water |publisher=Environmental Protection Agency |date=18 February 2022 |accessdate=13 January 2023}}</ref><ref name="Stahl-FigueroaMat21">{{cite web |url=https://www.intertek.com/blog/2021-11-30-foundation/ |title=Material Testing and Site Inspections: The Foundation of Successful Construction |author=Stahl-Figueroa, H. |work=Intertek Blog |publisher=Intertek Group plc |date=30 November 2021 |accessdate=13 January 2023}}</ref> Yet another example can be found with the analytical activities of the [[forensic laboratory]], which provides a diverse array of investigative services.<ref name="ANABISO15">{{cite web |url=https://www.qualtrax.com/isoiec-17025-or-17020-for-forensics/ |title=ISO/IEC 17025 or 17020 for Forensics? |author=ANAB |publisher=Qualtrax |date=30 October 2015 |accessdate=13 January 2023}}</ref> Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:
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| *analytical chemistry sampling<ref>{{Cite journal |date=2019 |title=The role of accreditation in ensuring sampling quality |url=http://xlink.rsc.org/?DOI=C9AY90095K |journal=Analytical Methods |language=en |volume=11 |issue=26 |pages=3358–3360 |doi=10.1039/C9AY90095K |issn=1759-9660}}</ref>;
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| *sampling and high-resolution gamma-ray spectrometry of environmental soil, tap water, and aerosol filters<ref>{{Cite journal |last=Glavič-Cindro |first=Denis |last2=Hazou |first2=Eyakifama |last3=Korun |first3=Matjaž |last4=Krištof |first4=Romana |last5=Osterman |first5=Petra |last6=Petrovič |first6=Toni |last7=Vodenik |first7=Branko |last8=Zorko |first8=Benjamin |date=2020-02 |title=Measurement uncertainty arising from sampling of environmental samples |url=https://linkinghub.elsevier.com/retrieve/pii/S0969804319303367 |journal=Applied Radiation and Isotopes |language=en |volume=156 |pages=108978 |doi=10.1016/j.apradiso.2019.108978}}</ref>;
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| *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>;
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| *individual and environmental dosimetry testing<ref>{{Cite journal |last=Romero |first=A. M. |last2=Rodríguez |first2=R. |last3=López |first3=J. L. |last4=Martín |first4=R. |last5=Benavente |first5=J. F. |date=2016-09 |title=CIEMAT EXTERNAL DOSIMETRY SERVICE: ISO/IEC 17025 ACCREDITATION AND 3 Y OF OPERATIONAL EXPERIENCE AS AN ACCREDITED LABORATORY |url=https://academic.oup.com/rpd/article-lookup/doi/10.1093/rpd/ncv472 |journal=Radiation Protection Dosimetry |language=en |volume=170 |issue=1-4 |pages=70–73 |doi=10.1093/rpd/ncv472 |issn=0144-8420}}</ref>;
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| *forensic paternity testing<ref>{{Cite journal |last=Morling |first=Niels |last2=Allen |first2=Robert W |last3=Carracedo |first3=Angel |last4=Geada |first4=Helena |last5=Guidet |first5=Francois |last6=Hallenberg |first6=Charlotte |last7=Martin |first7=Wolfgang |last8=Mayr |first8=Wolfgang R |last9=Olaisen |first9=Bjørnar |last10=Pascali |first10=Vince L |last11=Schneider |first11=Peter M |date=2002-10 |title=Paternity Testing Commission of the International Society of Forensic Genetics: recommendations on genetic investigations in paternity cases |url=https://linkinghub.elsevier.com/retrieve/pii/S037907380200289X |journal=Forensic Science International |language=en |volume=129 |issue=3 |pages=148–157 |doi=10.1016/S0379-0738(02)00289-X}}</ref>;
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| *forensic anthropology analyses<ref>{{Cite journal |last=Pierce |first=Michal L. |last2=Wiersema |first2=Jason M. |last3=Crowder |first3=Christian M. |date=2016-09 |title=Progress in the Accreditation of Anthropology Laboratories |url=http://journals.sagepub.com/doi/10.23907/2016.036 |journal=Academic Forensic Pathology |language=en |volume=6 |issue=3 |pages=344–348 |doi=10.23907/2016.036 |issn=1925-3621 |pmc=PMC6474551 |pmid=31239910}}</ref>; and
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| *forensic toxicology and drug analysis.<ref>{{Cite journal |last=Dror |first=Itiel E. |last2=Pierce |first2=Michal L. |date=2020-05 |title=ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work |url=https://onlinelibrary.wiley.com/doi/10.1111/1556-4029.14265 |journal=Journal of Forensic Sciences |language=en |volume=65 |issue=3 |pages=800–808 |doi=10.1111/1556-4029.14265 |issn=0022-1198}}</ref>
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| ====Product development and manufacturing labs====
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| These are a subset of the above-mentioned analytical and regulatory testing labs, with a routine focus on pre-market research and development (R&D) and quality control analyses that help bring a product or service to market. That testing is typically conducted early on in a product lifecycle, based upon a set of predetermined limits set by a manufacturer or other criteria that are in turn driven by regulations and/or customer requirements.<ref name="PillaiPract22" /> This sort of testing could occur with sourcing ingredients or components to ensure they are certified to not contain allergens or an acceptable and safe level of contaminants, such as heavy metals. It also occurs during the development phase to ensure that any proposed final recipe or manufacturing specification doesn't have any unexpected toxicology or errors and has a reasonable chance of going to market.<ref name="ManNetHowOrg17">{{cite web |url=https://www.manufacturing.net/home/article/13165177/how-organizations-can-improve-lab-testing-within-the-rd-process |title=How Organizations Can Improve Lab Testing Within the R&D Process |work=Manufacturing.net |date=14 June 2017 |accessdate=13 January 2023}}</ref><ref name="NSFPlastic">{{cite web |url=https://www.nsf.org/testing/lab-testing/plastic-plumbing-testing-rd-lab |title=Plastic and Plumbing Testing and R&D Lab Services |publisher=NSF |accessdate=13 January 2023}}</ref> Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:
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| *pesticide testing of honey<ref>{{Cite journal |last=Pirard |first=C. |last2=Widart |first2=J. |last3=Nguyen |first3=B.K. |last4=Deleuze |first4=C. |last5=Heudt |first5=L. |last6=Haubruge |first6=E. |last7=De Pauw |first7=E. |last8=Focant |first8=J.-F. |date=2007-06 |title=Development and validation of a multi-residue method for pesticide determination in honey using on-column liquid–liquid extraction and liquid chromatography–tandem mass spectrometry |url=https://linkinghub.elsevier.com/retrieve/pii/S002196730700502X |journal=Journal of Chromatography A |language=en |volume=1152 |issue=1-2 |pages=116–123 |doi=10.1016/j.chroma.2007.03.035}}</ref>;
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| *nitrogen, protein, moisture, and ash analysis of foodstuffs<ref>{{Cite journal |last=Cortés-Herrera |first=Carolina |last2=Quirós-Fallas |first2=Silvia |last3=Calderón-Calvo |first3=Eduardo |last4=Cordero-Madrigal |first4=Randall |last5=Jiménez |first5=Laura |last6=Granados-Chinchilla |first6=Fabio |last7=Artavia |first7=Graciela |date=2021 |title=Nitrogen/protein and one-step moisture and ash examination in foodstuffs: Validation case analysis using automated combustion and thermogravimetry determination under ISO/IEC 17025 guidelines |url=https://linkinghub.elsevier.com/retrieve/pii/S2665927121001040 |journal=Current Research in Food Science |language=en |volume=4 |pages=900–909 |doi=10.1016/j.crfs.2021.11.015 |pmc=PMC8646960 |pmid=34927085}}</ref>;
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| *toxic and allergenic component/contaminant analysis of consumer cosmetic, personal care, and building products <ref>{{Cite journal |last=Ducup de Saint Paul |first=Léa |last2=Ravier |first2=Sylvain |last3=Wortham |first3=Henri |last4=Maupetit |first4=François |last5=Nicolas |first5=Mélanie |last6=Quivet |first6=Etienne |date=2021-11 |title=Development and validation of a UPLC-MS/MS method for the quantification of isothiazolinones in the composition and emissions from consumer products |url=https://link.springer.com/10.1007/s00216-021-03627-7 |journal=Analytical and Bioanalytical Chemistry |language=en |volume=413 |issue=26 |pages=6617–6626 |doi=10.1007/s00216-021-03627-7 |issn=1618-2642}}</ref>;
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| *long-range infrared camera development<ref>{{Cite journal |last=Barela |first=Jaroslaw |last2=Firmanty |first2=Krzysztof |last3=Kastek |first3=Mariusz |date=2021-08-24 |title=Measurement and Analysis of the Parameters of Modern Long-Range Thermal Imaging Cameras |url=https://www.mdpi.com/1424-8220/21/17/5700 |journal=Sensors |language=en |volume=21 |issue=17 |pages=5700 |doi=10.3390/s21175700 |issn=1424-8220 |pmc=PMC8434484 |pmid=34502589}}</ref>; and
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| *veterinary low-dose ''Cannabis sativa'' extract development.<ref>{{Cite journal |last=Wakshlag |first=Joseph J |last2=Cital |first2=Stephen |last3=Eaton |first3=Scott J |last4=Prussin |first4=Reece |last5=Hudalla |first5=Christopher |date=2020-04 |title=Cannabinoid, Terpene, and Heavy Metal Analysis of 29 Over-the-Counter Commercial Veterinary Hemp Supplements |url=https://www.dovepress.com/cannabinoid-terpene-and-heavy-metal-analysis-of-29-over-the-counter-co-peer-reviewed-article-VMRR |journal=Veterinary Medicine: Research and Reports |language=en |volume=Volume 11 |pages=45–55 |doi=10.2147/VMRR.S248712 |issn=2230-2034 |pmc=PMC7169471 |pmid=32346530}}</ref>
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| ===Basic and applied research labs===
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| Basic research labs seek to understand and form theories concerning scientific questions, while applied research labs typically follow that basic research, conducting studies to apply that basic research towards solving practical problems. Both "conduct their work to support and inform the understanding of science", as well as drive regulatory support<ref name="PillaiPract22" />, and these lab can benefit from the recommended approach of ISO/IEC 17025. Basica and applied research labs may appear in academia, in government, or in private industry, studying a wide variety of topics. Research topics in ISO/IEC 17025-certified labs include (but is not limited to):
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| *veterinary parasitology<ref>{{Cite journal |last=Perusso |first=Cristiane Olier |last2=Nagata |first2=Walter Bertequini |last3=Inácio |first3=Sandra Valéria |last4=Castilho |first4=Gilmara |last5=Ferrari |first5=Alessandro Moreira |last6=Gomes |first6=Jancarlo Ferreira |last7=Bresciani |first7=Katia Denise Saraiva |date=2022-08 |title=Optimizing the quality of research in Veterinary Parasitology |url=https://linkinghub.elsevier.com/retrieve/pii/S0014489422000972 |journal=Experimental Parasitology |language=en |volume=239 |pages=108303 |doi=10.1016/j.exppara.2022.108303}}</ref>;
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| *environmental chemistry<ref>{{Cite journal |last=Rodima |first=Ako |last2=Vilbaste |first2=Martin |last3=Saks |first3=Olev |last4=Jakobson |first4=Erko |last5=Koort |first5=Eve |last6=Pihl |first6=Viljar |last7=Sooväli |first7=Lilli |last8=Jalukse |first8=Lauri |last9=Traks |first9=Julia |last10=Virro |first10=Kristina |last11=Annuk |first11=Heiki |date=2005-07 |title=ISO 17025 quality system in a university environment |url=http://link.springer.com/10.1007/s00769-005-0011-x |journal=Accreditation and Quality Assurance |language=en |volume=10 |issue=7 |pages=369–372 |doi=10.1007/s00769-005-0011-x |issn=0949-1775}}</ref>;
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| *diseases and their pathogenesis<ref name="PillaiPract22" />;
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| *pharmaceuticals<ref>{{Cite journal |last=Separovic |first=Luciana |last2=Simabukuro |first2=Renan S. |last3=Couto |first3=Aldo R. |last4=Bertanha |first4=Maria Luiza G. |last5=Dias |first5=Francielle R.S. |last6=Sano |first6=Adriano Y. |last7=Caffaro |first7=Arthur M. |last8=Lourenço |first8=Felipe R. |date=2021-06-21 |title=Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses – A Review |url=https://www.tandfonline.com/doi/full/10.1080/10408347.2021.1940086 |journal=Critical Reviews in Analytical Chemistry |language=en |pages=1–16 |doi=10.1080/10408347.2021.1940086 |issn=1040-8347}}</ref>; and
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| *contract research projects.<ref>{{Cite journal |last=Margham |first=Jennifer |last2=McAdam |first2=Kevin |last3=Forster |first3=Mark |last4=Liu |first4=Chuan |last5=Wright |first5=Christopher |last6=Mariner |first6=Derek |last7=Proctor |first7=Christopher |date=2016-10-17 |title=Chemical Composition of Aerosol from an E-Cigarette: A Quantitative Comparison with Cigarette Smoke |url=https://pubs.acs.org/doi/10.1021/acs.chemrestox.6b00188 |journal=Chemical Research in Toxicology |language=en |volume=29 |issue=10 |pages=1662–1678 |doi=10.1021/acs.chemrestox.6b00188 |issn=0893-228X}}</ref><br />
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| ===Reference measurement and calibration labs===
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| A [[Reference laboratory|reference]] or calibration laboratory performs reference or calibration measurement procedures, or assigns reference values to test objects, later potentially providing those associated reference values for references or sources of traceability of test results.<ref name="SHMMM83">{{cite book |url=https://books.google.com/books?id=8lANaR-Pqi4C&pg=PA83 |title=Springer Handbook of Materials Measurement Methods |editor=Czichos, Horst ; Saito, Tetsuya; Smith, Leslie R. |publisher=Springer |year=2006 |page=83–84 |isbn=3540303006 |accessdate=23 December 2022}}</ref><ref name="CBR149">{{cite journal |url=http://www.ifcc.org/media/147899/LS%20Clin%20Biochem%20Rev%202007_28_149-154.pdf |format=PDF |journal=The Clinical Biochemist Reviews |year=November 2007 |volume=28 |issue=4 |page=149–154 |title=Requirements for Reference (Calibration) Laboratories in Laboratory Medicine |author=Siekmann, Lothar |pmc=PMC2282407 |accessdate=23 December 2022}}</ref><ref name="ISO15195">{{cite web |url=https://www.iso.org/standard/69824.html |title=ISO 15195:2018 - Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures |publisher=International Organization for Standardization |date=December 2018 |accessdate=23 December 2022}}</ref> ISO/IEC 17025 saw the addition of calibration laboratories to its focus in 1990 through its predecessor document ISO/IEC Guide 25 ''General requirements for the competence of calibration and testing laboratories'' as a greater means of lending "support for national systems, thus easing bilateral agreements" associated with laboratory testing.<ref name="SquirrelConform08">{{cite journal |last=Squirrell |first=A. |date=2008-09 |title=Conformity assessment: providing confidence in testing and calibration |url=http://link.springer.com/10.1007/s00769-008-0418-2 |journal=Accreditation and Quality Assurance |language=en |volume=13 |issue=9 |pages=543–546 |doi=10.1007/s00769-008-0418-2 |issn=0949-1775}}</ref><ref name="MiguelISO21">{{Cite journal |last=Miguel |first=Anna |last2=Moreira |first2=Renata |last3=Oliveira |first3=André |date=2021 |title=ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS |url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf |journal=Química Nova |doi=10.21577/0100-4042.20170726}}</ref><ref name="VehringTested20">{{cite web |url=https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf |format=PDF |title=Tested & Accepted: Implementing ISO/IEC 17025:2017 |author=Vehring, S. |publisher=United Nations Industrial Development Organization |date=June 2020 |accessdate=13 January 2023}}</ref> In other words, with international trade hitting new records<ref name="UNCTDGlobal22">{{cite web |url=https://unctad.org/news/global-trade-hits-record-high-285-trillion-2021-likely-be-subdued-2022 |title=Global trade hits record high of $28.5 trillion in 2021, but likely to be subdued in 2022 |author=United Nations Conference on Trade and Development |work=UNCTAD News |date=17 February 2022 |accessdate=13 January 2023}}</ref>, it's more important than ever that an internationally recognized standardized approach to analyzing globally traded products is enacted, and the equipment and standards used for those analyses are themselves are properly calibrated and maintained.<ref name="ISHNISO">{{cite web |url=https://www.ishn.com/articles/107811-isoiec-17025--competence-of-testing-and-calibration-laboratories |archiveurl=https://web.archive.org/web/20190923060705/https://www.ishn.com/articles/107811-isoiec-17025--competence-of-testing-and-calibration-laboratories |title=ISO/IEC 17025- Competence of testing and calibration laboratories |author=ANSI |work=Industrial Safety & Hygiene News |date=26 December 2017 |archivedate=23 September 2019 |accessdate=13 January 2023}}</ref> (After all, when the biggest output of a lab is its analyses, it's best to ensure they are precise, accurate, and timely.) Laboratory equipment isn't all that's getting calibrated, however. These labs also calibrate important equipment in other fields of expertise. Examples of instruments and equipment getting calibrated to a standard in ISO/IEC 17025 calibration labs include:
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| *radiation monitoring instruments<ref name="RaoISO21" />;
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| *electronic medical equipment<ref>{{Cite journal |last=Llamosa-Rincón |first=Luis E |last2=López-Isaza |first2=Giovanni A |last3=Villarreal-Castro |first3=Milton F |date=2010-02 |title=Aspectos fundamentales para la acreditación de laboratorios de calibración de equipos médicos en Colombia |url=http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0124-00642010000100012&lng=es&nrm=iso&tlng=es |journal=Revista de Salud Pública |language=en |volume=12 |issue=1 |pages=126–134 |doi=10.1590/S0124-00642010000100012 |issn=0124-0064}}</ref>;
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| *laser and optical communication equipment<ref>{{Cite journal |last=Lehman |first=J.H. |last2=Vayshenker |first2=I. |last3=Livigni |first3=D.J. |last4=Hadler |first4=J. |date=2004-03 |title=Intramural comparison of NIST laser and optical fiber power calibrations |url=https://nvlpubs.nist.gov/nistpubs/jres/109/2/j92leh.pdf |journal=Journal of Research of the National Institute of Standards and Technology |volume=109 |issue=2 |pages=291 |doi=10.6028/jres.109.019 |pmc=PMC4853116 |pmid=27366611}}</ref>; and
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| *high-accuracy Global Navigation Satellite System-based instruments.<ref>{{Cite journal |last=Martucci |first=Adolfo |last2=Cerasuolo |first2=Giovanni |last3=Petrella |first3=Orsola |last4=Laracca |first4=Marco |date=2020-01-21 |title=On the Calibration of GNSS-Based Vehicle Speed Meters |url=https://www.mdpi.com/1424-8220/20/3/591 |journal=Sensors |language=en |volume=20 |issue=3 |pages=591 |doi=10.3390/s20030591 |issn=1424-8220 |pmc=PMC7037761 |pmid=31973137}}</ref>
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| ==A note about clinical laboratories==
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| You may notice that the [[clinical laboratory]] doesn't appear in the above listing. That is because quality management in the clinical lab is best guided by [[ISO 15189|ISO 15189:2022]] ''Medical laboratories — Requirements for quality and competence''. (This is not to say that ISO/IEC 17025-compliant environments haven't conducted clinical analyses, as they have<ref>{{Cite journal |last=Asprang |first=Aud Frøysa |last2=Jenum |first2=Pål A. |date=2003-11-06 |title=[What does accreditation of medical microbiological laboratories mean to patients?] |url=https://pubmed.ncbi.nlm.nih.gov/14618175 |journal=Tidsskrift for Den Norske Laegeforening: Tidsskrift for Praktisk Medicin, Ny Raekke |volume=123 |issue=21 |pages=3051–3053 |issn=0807-7096 |pmid=14618175}}</ref><ref>{{Cite journal |last=Weinmann |first=Wolfgang |last2=Schaefer |first2=Patrick |last3=Thierauf |first3=Annette |last4=Schreiber |first4=André |last5=Wurst |first5=Friedrich Martin |date=2004-02-01 |title=Confirmatory analysis of ethylglucuronide in urine by liquid-chromatography/electrospray ionization/tandem mass spectrometry according to forensic guidelines |url=https://pubs.acs.org/doi/10.1016/j.jasms.2003.10.010 |journal=Journal of the American Society for Mass Spectrometry |language=en |volume=15 |issue=2 |pages=188–193 |doi=10.1016/j.jasms.2003.10.010 |issn=1044-0305}}</ref><ref>{{Cite journal |last=Cay |first=A.B. |last2=Van Der Stede |first2=Stede Y. |date=2010-12-01 |title=Influence of the incubation temperature and the batch components on the sensitivity of an enzyme-linked immunoabsorbent assay to detect Aujeszky's diseaese virus glycoprotein E (gE) |url=https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=31143 |journal=Revue Scientifique et Technique de l'OIE |volume=29 |issue=3 |pages=565–571 |doi=10.20506/rst.29.3.2002 |issn=0253-1933}}</ref><ref>{{Cite journal |last=Gerace |first=E. |last2=Salomone |first2=A. |last3=Fasano |first3=F. |last4=Costa |first4=R. |last5=Boschi |first5=D. |last6=Di Stilo |first6=A. |last7=Vincenti |first7=M. |date=2011-04 |title=Validation of a GC/MS method for the detection of two quinolinone-derived selective androgen receptor modulators in doping control analysis |url=http://link.springer.com/10.1007/s00216-010-4569-8 |journal=Analytical and Bioanalytical Chemistry |language=en |volume=400 |issue=1 |pages=137–144 |doi=10.1007/s00216-010-4569-8 |issn=1618-2642}}</ref>, but it's not the most ideal standard to be compliant with in the clinical environment, and ISO 15189 is increasingly common in hospital and clinical labs.<ref>{{Cite journal |last=Wilson |first=Ian G. |last2=Smye |first2=Michael |last3=Wallace |first3=Ian J. C. |date=2016-02 |title=Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes |url=https://pubmed.ncbi.nlm.nih.gov/26620076 |journal=MicrobiologyOpen |volume=5 |issue=1 |pages=95–105 |doi=10.1002/mbo3.314 |issn=2045-8827 |pmc=4767433 |pmid=26620076}}</ref>) 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 arguably 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>
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| 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
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| 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>
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| 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]]."
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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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