Template:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Introduction to ISO/IEC 17025/How we benefit from ISO/IEC 17025 laboratories

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1.3 How we benefit from ISO/IEC 17025 laboratories

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The discussion so far has been useful in giving background about standards bodies giving organizations—including laboratories—a framework for improving operational quality, but how does this all relate to the primary question about ISO/IEC 17025 benefiting society? From here, it's useful to examine the importance of the laboratory itself to society. In the guide The Laboratories of Our Lives: Labs, Labs Everywhere!, the first chapter emphasizes the ubiquity of the laboratory in the fabric of society, despite the lab being largely invisible to the average individual[1]:

Laboratories play an integral role in modern life, ubiquitous and often unseen by the average person. They improve quality of life, act as hotbeds of discovery, and help us make sense of our universe, particularly in the capable hands of the tens of thousands of professionals who work in them. But the laboratory as we know it today is actually a relatively new concept. It wasn't always as sectionally organized, well-staffed, and well-equipped. To gain a better sense of how common the laboratory is to our lives, we must first briefly look at the past history of laboratory research and how it developed from a philosophical and more selfish endeavor to one more focused on analysis and the benefits to society.

Labs can be a hotbed of economic activity, as found with the United States' Argonne National Laboratory in Illinois, which claimed in 2021 to employ more than 3,400 people and have an approximately $168 million total economic impact on the state.[2] Labs can also be a significant source of innovation to society, with the old Bell Telephone Laboratories at its peak employing some 1,200 PhDs and being responsible for the creation of vital technologies such as solid state components, wireless telephony technology, the C programming language, and the Unix operating system (thanks to Bell researchers like Ken Thompson and Dennis Ritchie).[3] In fact, laboratories are often at the heart of a company's R&D efforts towards bringing people new products. Vehicle[4] and makeup[5] users alike are affected by manufacturing laboratories that research, design, test, and quality control their products. Clinical labs help keep current and future generations healthy, and forensic labs help bring justice to the wronged. Of course, calibration laboratories are vital to ensuring the precise measurement and production values of any equipment those other laboratories strongly depend on.

However, labs can and do fail (completely, or at their tasks)[6][7][8], like any other business. This can happen for a number of reasons[6][7], though insufficient attention to risk and quality management is usually a major contributor.[8][9][10] In fact, data and quality management are arguably at the heart of aiding not only in reducing errors in laboratory processes but also more rapidly recovering from errors in and strengthening the quality of processes.

Labs of all types should be addressing quality within their operations, particularly when those operations affect human and animal health. "Quality management is as applicable for the medical laboratory as it is for manufacturing and industry," states the World Health Organization (WHO) in its 2011 Laboratory Quality Management System: Handbook.[11] While the medical laboratory is better covered by ISO 15189 for its quality needs, the WHO's statement highlights that all laboratories can benefit from implementing quality management principles. This includes food and beverage laboratories, water and wastewater laboratories, and calibration laboratories, among many others.

Past research has shown that a well-implemented quality plan, paired with quality indicators, is significantly associated with improving laboratory services and client satisfaction.[12] In particular, the customer or client is increasingly seen as the most important element driving laboratory quality, supported by effective QMS implementation and improvement. "A QMS with customer focus as its heart is the core foundation for a business striving to attain distinction irrespective of technology, commercial strategy or organizational philosophy," notes Udoh and Eluwole, adding that "at the end of the day, the quality of a product will be determined by whether or not it fulfills customer requirements."[13] By extension, the end user of a product or service will be not only more satisfied but also safer for it.

One can look to the Galaxy Note 7 battery explosion issue from Samsung in 2016 as an example, with 13 people known to have been injured and 47 reports of property damage having been filed.[14] Later analysis by Counterpoint Research noted of the Galaxy Note 7 situation that “very often, laboratory times and testing periods are shrunk to expedite approval and release-to-market of key devices; it is possible all charging scenarios were not thoroughly tested."[13] The end result is injuries, property loss, and dissatisfied customers who begin to look elsewhere for a safer, more reliable product. The clinical and public health lab offers another example, with the World Health Organization (WHO) noting the negative consequences of laboratory error include unnecessary treatment, treatment complications, failure to provide the proper treatment, a delay in a correct diagnosis, greater costs, and poor patient outcomes. The cure, they add, is effectively implementing the QMS and adopting internationally recognized laboratory standards.[15] Finally, the food supply chain can become adulterated by lack of quality and regulation (i.e., food fraud); however, laboratories focused of fighting food fraud and ensuring manufacturer quality help reduce public health threats, improve customer confidence and satisfaction, and improve economic output.[16]

Quality management also improves overall costs and efficiency for not only the laboratory but also society.[17][18][19][20] Raiborn and Payne noted this in the mid-1990s while discussing the topic of "total quality management"[20]:

Who benefits from prompt, reasonable-cost throughput? The answer is easy: everyone. Customers benefit because they get what they want, when they want it, and at a reasonable price. Satisfied customers are repeat customers, which means that employees benefit because production and, therefore, jobs will continue. The company benefits because shortened lead time means lowered investment and faster cash flow; satisfied, repeat customers and efficient processes also mean higher profits and, thus, happy stockholders. Society benefits because there is greater availability of resources for alternative purposes since prices have fallen (or greater value is being provided for the same price) and companies will continue in business, providing numerous positive societal effects from their existence (tax payments, employment, charitable contributions, etc.).

While Raiborn and Payne's quote specifically refers to improvements in costs and efficiency within the organization due to proper quality management, their words sum up quite well the overall benefits to society laboratory quality management brings. A product or service—whether it be the analytical results of the laboratory itself or the larger macro view of safer, more high-quality products and services via laboratory testing—that meets customer requirements is the end result of quality laboratory work, and society benefits from it thanks in part to well-implemented quality management mechanisms. Without them, products and services are more risky to use, more apt to have health-impeding impurities and contaminates, less beneficial, and more expensive.

  1. Douglas, S.E. (July 2022). "1. Laboratories: A historical perspective". The Laboratories of Our Lives: Labs, Labs Everywhere!. LIMSwiki. https://www.limswiki.org/index.php/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!/Laboratories:_A_historical_perspective. Retrieved 11 February 2023. 
  2. "Argonne Impacts State by State: Illinois". Argonne National Laboratory. UChicago Argonne, LLC. https://www.anl.gov/argonne-impacts/illinois. Retrieved 11 February 2023. 
  3. Gertner, J. (2013). The Idea Factory: Bell Labs and the Great Age of American Innovation. Penguin. pp. 422. ISBN 9780143122791. https://books.google.com/books?id=OkECDAAAQBAJ. 
  4. "Materials Technology". Volvo Group. AB Volvo. Archived from the original on 29 June 2017. https://web.archive.org/web/20170629222307/http://www.volvogroup.com/en-en/about-us/r-d-and-innovations/materials-technology.html. Retrieved 11 February 2023. 
  5. "L’Oréal USA Research And Innovation". L’Oréal Group. Archived from the original on 21 October 2018. https://web.archive.org/web/20181021232022/http://www.lorealusa.com/group/discover-l'or%C3%A9al-usa/l%E2%80%99or%C3%A9al-usa-research-and-innovation. Retrieved 11 February 2023. 
  6. 6.0 6.1 Ahuja, S.B. (22 July 2019). "Why Innovation Labs Fail, and How to Ensure Yours Doesn’t". Harvard Business Review. https://hbr.org/2019/07/why-innovation-labs-fail-and-how-to-ensure-yours-doesnt. Retrieved 11 February 2023. 
  7. 7.0 7.1 Keppel, Martin H; Cadamuro, Janne; Haschke-Becher, Elisabeth; Oberkofler, Hannes; Felder, Thomas K; Lippi, Giuseppe; Mrazek, Cornelia (15 June 2020). "Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions". Biochemia medica 30 (2): 215–233. doi:10.11613/BM.2020.020502. PMC PMC7271754. PMID 32550813. https://www.biochemia-medica.com/en/journal/30/2/10.11613/BM.2020.020502. 
  8. 8.0 8.1 Parvin, C.A.; Yundt-Pacheco, J.; Quintenz, A. (2015). "Monitoring test system failures and QC performance can help identify opportunities for improvement". QCNet. https://www.qcnet.com/resources/qc-articles/learning-from-laboratory-failures. Retrieved 11 February 2023. 
  9. Mortimer, Sharon T.; Mortimer, David (2015). "Chapter 4: What is risk?". Quality and risk management in the IVF laboratory (Second edition ed.). Cambridge, United Kingdom ; New York: Cambridge University Press. pp. 39–48. ISBN 978-1-107-42128-8. 
  10. Murray, W. (10 May 2016). "Exploring Risk Management in the Lab: Risk-based decisionmaking and appropriate analytical tools can improve lab quality". CLP Magazine. https://clpmag.com/lab-essentials/quality-systems/exploring-risk-management-lab/. Retrieved 11 February 2023. 
  11. 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. 
  12. Mulleta, Daba; Jaleta, Fraol; Banti, Haile; Bekele, Bayissa; Abebe, Wake; Tadesse, Henok; Eshetu, Legesse; Zewdu, Adinew et al. (1 July 2021). "The Impact of Laboratory Quality Management System Implementation on Quality Laboratory Service Delivery in Health Center Laboratories of Oromia Region, Ethiopia" (in en). Pathology and Laboratory Medicine International Volume 13: 7–19. doi:10.2147/PLMI.S314656. ISSN 1179-2698. https://www.dovepress.com/the-impact-of-laboratory-quality-management-system-implementation-on-q-peer-reviewed-fulltext-article-PLMI. 
  13. 13.0 13.1 Udoh, N.; Eluwole, O.T. (July 2017). "The Impact of Quality Management System in Laboratory Certification of Smartcards and Emerging Payment Technologies" (PDF). Proceedings of the World Congress on Engineering 2017, Volume II. ISBN 978-988-14048-3-1. https://www.iaeng.org/publication/WCE2017/WCE2017_pp738-743.pdf. Retrieved 11 February 2023. 
  14. Heathman, A. (24 January 2017). "We finally know why Samsung's Galaxy Note 7s 'exploded'". Wired. https://www.wired.co.uk/article/galaxy-note-7-issues-what-happened. Retrieved 11 February 2023. 
  15. World Health Organization. "Module 1, Overview of the Quality System, Introduction" (PDF). pp. 1–9. https://extranet.who.int/hslp/who-hslp-download/package/501/material/168. Retrieved 11 February 2023. 
  16. Spink, John; Moyer, Douglas C.; Park, Hyeonho; Wu, Yongning; Fersht, Victor; Shao, Bing; Hong, Miao; Paek, Seung Yeop et al. (1 December 2015). "Introducing Food Fraud including translation and interpretation to Russian, Korean, and Chinese languages" (in en). Food Chemistry 189: 102–107. doi:10.1016/j.foodchem.2014.09.106. https://linkinghub.elsevier.com/retrieve/pii/S0308814614014824. 
  17. 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. 
  18. Garber Metrology (14 December 2021). "A Guide to ISO 17025 Calibration and Compliance". Garber Metrology Blog. https://www.garbermetrology.com/iso-17025/. Retrieved 11 February 2023. 
  19. "What is ISO 17025?". Advisera Expert Solutions Ltd. 2022. https://advisera.com/17025academy/what-is-iso-17025/. Retrieved 11 February 2023. 
  20. 20.0 20.1 Raiborn, Cecily; Payne, Dinah (1 September 1996). "TQM: Just what the ethicist ordered" (in en). Journal of Business Ethics 15 (9): 963–972. doi:10.1007/BF00705576. ISSN 0167-4544. http://link.springer.com/10.1007/BF00705576.