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Water quality testing in the lab (6f16fede-a75c-4444-af64-a339dff12012).JPG

Title: What types of laboratory testing are affected by ISO/IEC 17025?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: TBD

Introduction

International Organization for Standardization (ISO)


Laboratories using ISO/IEC 17025

ISO/IEC 17025:2017 is an international standard that dictates how a laboratory demonstrates "competence, impartiality, and consistent operation" in all of its activities.[1] 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."[1] 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."[1] 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.

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).[2]

Analytical and regulatory testing labs

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 mandate concering safety and efficacy.[2] 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.[2] Additionally, federal, state, and local governments also have to follow regulations concerning frequent testing of municipal infrastructure, including water, wastewater, and construction activities.[3][4] Yet another example can be found with the analytical activities of the forensic laboratory, which provides a diverse array of investigative services.[5] Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:

  • analytical chemistry sampling[6];
  • sampling and high-resolution gamma-ray spectrometry of environmental soil, tap water, and aerosol filters[7];
  • radiological testing of food and drinking water[8];
  • individual and environmental dosimetry testing[9];
  • forensic paternity testing[10];
  • forensic anthropology analyses[11]; and
  • forensic toxicology and drug analysis[12].

Product development and manufacturing labs

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.[2] 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.[13][14] Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:

  • pesticide testing of honey[15];
  • nitrogen, protein, moisture, and ash analysis of foodstuffs[16];
  • toxic and allergenic component/contaminant analysis of consumer cosmetic, personal care, and building products [17];
  • long-range infrared camera development[18]; and
  • veterinary low-dose Cannabis sativa extract development[19].

Basic and applied research labs

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"[2] and can benefit from the recommended approach of ISO/IEC 17025.

  • veterinary parasitology[20]
  • environmental chemistry[21]
  • diseases and their pathogenesis[2]
  • pharmaceuticals[22]
  • contract research[23]

Reference measurement and calibration labs

A 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.[24][25][26]

  • radiation monitoring instruments[8]
  • electronic medical equipment[27]
  • laser and optical communication equipment[28]
  • high-accuracy Global Navigation Satellite System-based instruments[29]


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 best guided by 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[30][31][32][33], 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.[34]) 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."[35] Development of the standard began in the mid-1990s due to the lack of applicability ISO/IEC 17025 and 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).[36] 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.[37]

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[38][39]).[37] 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.[37][40]

For more on this topic, see Plebani and Sciacovelli's "ISO 15189 accreditation: Navigation between quality management and patient safety."


Conclusion

References

  1. ↑ 1.0 1.1 1.2 "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 23 December 2022. 
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 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. 
  3. ↑ "Regulatory and Guidance Information by Topic: Water". Environmental Protection Agency. 18 February 2022. https://www.epa.gov/regulatory-information-topic/regulatory-and-guidance-information-topic-water. Retrieved 13 January 2023. 
  4. ↑ Stahl-Figueroa, H. (30 November 2021). "Material Testing and Site Inspections: The Foundation of Successful Construction". Intertek Blog. Intertek Group plc. https://www.intertek.com/blog/2021-11-30-foundation/. Retrieved 13 January 2023. 
  5. ↑ ANAB (30 October 2015). "ISO/IEC 17025 or 17020 for Forensics?". Qualtrax. https://www.qualtrax.com/isoiec-17025-or-17020-for-forensics/. Retrieved 13 January 2023. 
  6. ↑ "The role of accreditation in ensuring sampling quality" (in en). Analytical Methods 11 (26): 3358–3360. 2019. doi:10.1039/C9AY90095K. ISSN 1759-9660. http://xlink.rsc.org/?DOI=C9AY90095K. 
  7. ↑ Glavič-Cindro, Denis; Hazou, Eyakifama; Korun, Matjaž; Krištof, Romana; Osterman, Petra; Petrovič, Toni; Vodenik, Branko; Zorko, Benjamin (1 February 2020). "Measurement uncertainty arising from sampling of environmental samples" (in en). Applied Radiation and Isotopes 156: 108978. doi:10.1016/j.apradiso.2019.108978. https://linkinghub.elsevier.com/retrieve/pii/S0969804319303367. 
  8. ↑ 8.0 8.1 Rao, Dd (2021). "ISO/IEC 17025: Accreditation standard for testing and calibration laboratories" (in en). Radiation Protection and Environment 44 (3): 121. doi:10.4103/rpe.rpe_41_21. ISSN 0972-0464. http://www.rpe.org.in/text.asp?2021/44/3/121/334784. 
  9. ↑ Romero, A. M.; Rodríguez, R.; López, J. L.; Martín, R.; Benavente, J. F. (1 September 2016). "CIEMAT EXTERNAL DOSIMETRY SERVICE: ISO/IEC 17025 ACCREDITATION AND 3 Y OF OPERATIONAL EXPERIENCE AS AN ACCREDITED LABORATORY" (in en). Radiation Protection Dosimetry 170 (1-4): 70–73. doi:10.1093/rpd/ncv472. ISSN 0144-8420. https://academic.oup.com/rpd/article-lookup/doi/10.1093/rpd/ncv472. 
  10. ↑ Morling, Niels; Allen, Robert W; Carracedo, Angel; Geada, Helena; Guidet, Francois; Hallenberg, Charlotte; Martin, Wolfgang; Mayr, Wolfgang R et al. (1 October 2002). "Paternity Testing Commission of the International Society of Forensic Genetics: recommendations on genetic investigations in paternity cases" (in en). Forensic Science International 129 (3): 148–157. doi:10.1016/S0379-0738(02)00289-X. https://linkinghub.elsevier.com/retrieve/pii/S037907380200289X. 
  11. ↑ Pierce, Michal L.; Wiersema, Jason M.; Crowder, Christian M. (1 September 2016). "Progress in the Accreditation of Anthropology Laboratories" (in en). Academic Forensic Pathology 6 (3): 344–348. doi:10.23907/2016.036. ISSN 1925-3621. PMC PMC6474551. PMID 31239910. http://journals.sagepub.com/doi/10.23907/2016.036. 
  12. ↑ Dror, Itiel E.; Pierce, Michal L. (1 May 2020). "ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work" (in en). Journal of Forensic Sciences 65 (3): 800–808. doi:10.1111/1556-4029.14265. ISSN 0022-1198. https://onlinelibrary.wiley.com/doi/10.1111/1556-4029.14265. 
  13. ↑ "How Organizations Can Improve Lab Testing Within the R&D Process". Manufacturing.net. 14 June 2017. https://www.manufacturing.net/home/article/13165177/how-organizations-can-improve-lab-testing-within-the-rd-process. Retrieved 13 January 2023. 
  14. ↑ "Plastic and Plumbing Testing and R&D Lab Services". NSF. https://www.nsf.org/testing/lab-testing/plastic-plumbing-testing-rd-lab. Retrieved 13 January 2023. 
  15. ↑ Pirard, C.; Widart, J.; Nguyen, B.K.; Deleuze, C.; Heudt, L.; Haubruge, E.; De Pauw, E.; Focant, J.-F. (1 June 2007). "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" (in en). Journal of Chromatography A 1152 (1-2): 116–123. doi:10.1016/j.chroma.2007.03.035. https://linkinghub.elsevier.com/retrieve/pii/S002196730700502X. 
  16. ↑ Cortés-Herrera, Carolina; Quirós-Fallas, Silvia; Calderón-Calvo, Eduardo; Cordero-Madrigal, Randall; Jiménez, Laura; Granados-Chinchilla, Fabio; Artavia, Graciela (2021). "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" (in en). Current Research in Food Science 4: 900–909. doi:10.1016/j.crfs.2021.11.015. PMC PMC8646960. PMID 34927085. https://linkinghub.elsevier.com/retrieve/pii/S2665927121001040. 
  17. ↑ Ducup de Saint Paul, Léa; Ravier, Sylvain; Wortham, Henri; Maupetit, François; Nicolas, Mélanie; Quivet, Etienne (1 November 2021). "Development and validation of a UPLC-MS/MS method for the quantification of isothiazolinones in the composition and emissions from consumer products" (in en). Analytical and Bioanalytical Chemistry 413 (26): 6617–6626. doi:10.1007/s00216-021-03627-7. ISSN 1618-2642. https://link.springer.com/10.1007/s00216-021-03627-7. 
  18. ↑ Barela, Jaroslaw; Firmanty, Krzysztof; Kastek, Mariusz (24 August 2021). "Measurement and Analysis of the Parameters of Modern Long-Range Thermal Imaging Cameras" (in en). Sensors 21 (17): 5700. doi:10.3390/s21175700. ISSN 1424-8220. PMC PMC8434484. PMID 34502589. https://www.mdpi.com/1424-8220/21/17/5700. 
  19. ↑ Wakshlag, Joseph J; Cital, Stephen; Eaton, Scott J; Prussin, Reece; Hudalla, Christopher (1 April 2020). "Cannabinoid, Terpene, and Heavy Metal Analysis of 29 Over-the-Counter Commercial Veterinary Hemp Supplements" (in en). Veterinary Medicine: Research and Reports Volume 11: 45–55. doi:10.2147/VMRR.S248712. ISSN 2230-2034. PMC PMC7169471. PMID 32346530. https://www.dovepress.com/cannabinoid-terpene-and-heavy-metal-analysis-of-29-over-the-counter-co-peer-reviewed-article-VMRR. 
  20. ↑ Perusso, Cristiane Olier; Nagata, Walter Bertequini; Inácio, Sandra Valéria; Castilho, Gilmara; Ferrari, Alessandro Moreira; Gomes, Jancarlo Ferreira; Bresciani, Katia Denise Saraiva (1 August 2022). "Optimizing the quality of research in Veterinary Parasitology" (in en). Experimental Parasitology 239: 108303. doi:10.1016/j.exppara.2022.108303. https://linkinghub.elsevier.com/retrieve/pii/S0014489422000972. 
  21. ↑ Rodima, Ako; Vilbaste, Martin; Saks, Olev; Jakobson, Erko; Koort, Eve; Pihl, Viljar; Sooväli, Lilli; Jalukse, Lauri et al. (1 July 2005). "ISO 17025 quality system in a university environment" (in en). Accreditation and Quality Assurance 10 (7): 369–372. doi:10.1007/s00769-005-0011-x. ISSN 0949-1775. http://link.springer.com/10.1007/s00769-005-0011-x. 
  22. ↑ Separovic, Luciana; Simabukuro, Renan S.; Couto, Aldo R.; Bertanha, Maria Luiza G.; Dias, Francielle R.S.; Sano, Adriano Y.; Caffaro, Arthur M.; Lourenço, Felipe R. (21 June 2021). "Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses – A Review" (in en). Critical Reviews in Analytical Chemistry: 1–16. doi:10.1080/10408347.2021.1940086. ISSN 1040-8347. https://www.tandfonline.com/doi/full/10.1080/10408347.2021.1940086. 
  23. ↑ Margham, Jennifer; McAdam, Kevin; Forster, Mark; Liu, Chuan; Wright, Christopher; Mariner, Derek; Proctor, Christopher (17 October 2016). "Chemical Composition of Aerosol from an E-Cigarette: A Quantitative Comparison with Cigarette Smoke" (in en). Chemical Research in Toxicology 29 (10): 1662–1678. doi:10.1021/acs.chemrestox.6b00188. ISSN 0893-228X. https://pubs.acs.org/doi/10.1021/acs.chemrestox.6b00188. 
  24. ↑ Czichos, Horst ; Saito, Tetsuya; Smith, Leslie R., ed. (2006). Springer Handbook of Materials Measurement Methods. Springer. p. 83–84. ISBN 3540303006. https://books.google.com/books?id=8lANaR-Pqi4C&pg=PA83. Retrieved 23 December 2022. 
  25. ↑ Siekmann, Lothar (November 2007). "Requirements for Reference (Calibration) Laboratories in Laboratory Medicine" (PDF). The Clinical Biochemist Reviews 28 (4): 149–154. PMC PMC2282407. http://www.ifcc.org/media/147899/LS%20Clin%20Biochem%20Rev%202007_28_149-154.pdf. Retrieved 23 December 2022. 
  26. ↑ "ISO 15195:2018 - Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures". International Organization for Standardization. December 2018. https://www.iso.org/standard/69824.html. Retrieved 23 December 2022. 
  27. ↑ Llamosa-Rincón, Luis E; López-Isaza, Giovanni A; Villarreal-Castro, Milton F (1 February 2010). "Aspectos fundamentales para la acreditación de laboratorios de calibración de equipos médicos en Colombia" (in en). Revista de Salud Pública 12 (1): 126–134. doi:10.1590/S0124-00642010000100012. ISSN 0124-0064. http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0124-00642010000100012&lng=es&nrm=iso&tlng=es. 
  28. ↑ Lehman, J.H.; Vayshenker, I.; Livigni, D.J.; Hadler, J. (1 March 2004). "Intramural comparison of NIST laser and optical fiber power calibrations". Journal of Research of the National Institute of Standards and Technology 109 (2): 291. doi:10.6028/jres.109.019. PMC PMC4853116. PMID 27366611. https://nvlpubs.nist.gov/nistpubs/jres/109/2/j92leh.pdf. 
  29. ↑ Martucci, Adolfo; Cerasuolo, Giovanni; Petrella, Orsola; Laracca, Marco (21 January 2020). "On the Calibration of GNSS-Based Vehicle Speed Meters" (in en). Sensors 20 (3): 591. doi:10.3390/s20030591. ISSN 1424-8220. PMC PMC7037761. PMID 31973137. https://www.mdpi.com/1424-8220/20/3/591. 
  30. ↑ Asprang, Aud Frøysa; Jenum, Pål A. (6 November 2003). "[What does accreditation of medical microbiological laboratories mean to patients?"]. Tidsskrift for Den Norske Laegeforening: Tidsskrift for Praktisk Medicin, Ny Raekke 123 (21): 3051–3053. ISSN 0807-7096. PMID 14618175. https://pubmed.ncbi.nlm.nih.gov/14618175. 
  31. ↑ Weinmann, Wolfgang; Schaefer, Patrick; Thierauf, Annette; Schreiber, André; Wurst, Friedrich Martin (1 February 2004). "Confirmatory analysis of ethylglucuronide in urine by liquid-chromatography/electrospray ionization/tandem mass spectrometry according to forensic guidelines" (in en). Journal of the American Society for Mass Spectrometry 15 (2): 188–193. doi:10.1016/j.jasms.2003.10.010. ISSN 1044-0305. https://pubs.acs.org/doi/10.1016/j.jasms.2003.10.010. 
  32. ↑ Cay, A.B.; Van Der Stede, Stede Y. (1 December 2010). "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)". Revue Scientifique et Technique de l'OIE 29 (3): 565–571. doi:10.20506/rst.29.3.2002. ISSN 0253-1933. https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=31143. 
  33. ↑ Gerace, E.; Salomone, A.; Fasano, F.; Costa, R.; Boschi, D.; Di Stilo, A.; Vincenti, M. (1 April 2011). "Validation of a GC/MS method for the detection of two quinolinone-derived selective androgen receptor modulators in doping control analysis" (in en). Analytical and Bioanalytical Chemistry 400 (1): 137–144. doi:10.1007/s00216-010-4569-8. ISSN 1618-2642. http://link.springer.com/10.1007/s00216-010-4569-8. 
  34. ↑ Wilson, Ian G.; Smye, Michael; Wallace, Ian J. C. (1 February 2016). "Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes". MicrobiologyOpen 5 (1): 95–105. doi:10.1002/mbo3.314. ISSN 2045-8827. PMC 4767433. PMID 26620076. https://pubmed.ncbi.nlm.nih.gov/26620076. 
  35. ↑ "ISO 15189:2022 Medical laboratories — Requirements for quality and competence". International Organization for Standardization. December 2022. https://www.iso.org/standard/76677.html. Retrieved 23 December 2022. 
  36. ↑ Plebani, Mario; Sciacovelli, Laura (1 September 2017). "ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety". Journal of Medical Biochemistry 36 (3): 225–230. doi:10.1515/jomb-2017-0038. ISSN 1452-8266. PMC PMC6287216. PMID 30564060. https://scindeks.ceon.rs/article.aspx?artid=1452-82581703225P. 
  37. ↑ 37.0 37.1 37.2 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. 
  38. ↑ National Committee for Clinical Laboratory Standards (November 2004). "CLSI HS01-A2". ANSI. https://webstore.ansi.org/standards/clsi/clsihs01a2. 
  39. ↑ National Committee for Clinical Laboratory Standards (November 2004). "CLSI GP26-A3". ANSI. https://webstore.ansi.org/standards/clsi/clsigp26a3. 
  40. ↑ Clinical and Laboratory Standards Institute (2022). "Quality System Essentials". Clinical and Laboratory Standards Institute. https://clsi.org/standards-development/quality-system-essentials/. 
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