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| ==1. Introduction to ISO/IEC 17025==
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| [[ISO/IEC 17025|ISO/IEC 17025:2017]] ''General requirements for the competence of testing and calibration laboratories'' is an internationally recognized standard that places requirements on testing, calibration, and [[Sample (material)|sampling]] [[Laboratory|laboratories]] to demonstrate "the competence, impartiality, and consistent operation" of their business 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=20 January 2023}}</ref> At its core, the standard places a strong focus on implementing procedural and [[Quality (business)|quality]] management mechanisms as a means towards meeting those goals. ISO/IEC 17025 has a long history that dates back to a time when international trade in the 1970s saw Japan leading the charge with its total quality efforts, driven by the desire to rebuild shattered industries after World War II. Japanese products just couldn't compete with the quality of other industrialized nations, and the Japanese clamored for something better. That focus on total quality eventually spread Westward in the 1980s.<ref name="ASQTotal">{{cite web |url=https://asq.org/quality-resources/history-of-quality#development |title=Total Quality |work=Learn About Quality |publisher=American Society for Quality |accessdate=20 January 2023}}</ref><ref>{{Cite journal |date=1993-01 |title=Total quality management: myth or miracle? |url=http://www.tandfonline.com/doi/abs/10.1080/09544129300000048 |journal=Total Quality Management |language=en |volume=4 |issue=4 |pages=5–8 |doi=10.1080/09544129300000048 |issn=0954-4127}}</ref> To this day, this desire for higher-quality goods and services by customers, clients, and other stakeholders continues to drive innovation and expansion in industry. Such is the path with quality, a trait demanded by and benefiting society in many ways. | |
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| | '''Title''': ''LIMS Selection Guide for Materials Testing Laboratories'' |
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| ===1.1 History of ISO/IEC 17025===
| | '''Edition''': First Edition |
| ISO/IEC 17025's origins go back to the mid-1970s, when a conference on cross-border acceptance of laboratory test data led to the International Laboratory Accreditation Cooperation (ILAC) beginning work on what would eventually become ISO Guide 25 ''Guidelines for assessing the technical competence of testing laboratories'', with that work ultimately getting turned over to the [[International Organization for Standardization]] (ISO). The intent of developing the guide, published in 1978, was to gain international cooperation towards improving the world's laboratory services by promoting a scheme for accredited laboratory test results, such that the results could be more readily accepted across national borders.<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=20 January 2023}}</ref> That first guide didn't address the activities of [[Reference laboratory|calibration labs]], however, and it would require further revisions, as the general guidelines towards proving a lab's technical competence were also inadequate.<ref name="MiguelISO21" /> For the next version—released in 1982 as ISO/IEC Guide 25: ''General requirements for the technical competence of testing laboratories''—the [[International Electrotechnical Commission]] (IEC) became involved. That version saw upgrades in proving technical competence, as well as the addition of the requirement for a quality system, though this revision also didn't address calibration labs.<ref name="MiguelISO21" /> The next version, released in 1990 as ISO/IEC Guide 25 ''General requirements for the competence of calibration and testing laboratories'', finally addressed calibration labs and, with the help of the Council Committee on Conformity Assessment (CASCO), lent "support for national systems, thus easing bilateral agreements" associated with laboratory testing.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" /> It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the ISO 9000 standard, which also focused on quality. Four years later, CASCO pushed to turn ISO/IEC Guide 25 into a full standard, and by 1999, ISO/IEC 17025:1999 ''General requirements for the competence of testing and calibration laboratories'' was born, which also met the requirements of ISO 9001.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" />
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| Since then, the standard has seen two additional revisions, one in 2005 and another in 2017.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" /> With the ISO 9001 standard being in revision at the same time ISO/IEC 17025:1999 was ready to release, the standard's views on ISO 9001 when published were antiquated, requiring the 2005 update.<ref name="MiguelISO21" /> The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from its 2005 predecessor, with the 2005 division between technical management and quality management being replaced by "a more unified focus on a laboratory's general responsibility management."<ref name="MiguelISO21" /> (For more on the differences between the 2005 and 2017 version, see the National Association of Testing Authorities' (NATA's) [https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf gap analysis document] comparing the two.<ref name="NATAGeneral18">{{cite web |url=https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf |format=PDF |title=General Accreditation Guidance: ISO/IEC 17025:2017 Gap analysis |author=National Association of Testing Authorities |date=April 2018 |accessdate=20 January 2023}}</ref>) As of January 2023, ISO/IEC 17025:2017 remains the latest version of the standard, putting a focus on labs seeking competent, impartial, and consistent results, with a focus on an efficient management system (i.e., a [[quality management system]] or QMS).
| | '''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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| ===1.2 ISO/IEC 17025 vs. ISO 9001===
| | '''Publication date''': ??? 2023 |
| Given the history of ISO/IEC 17025, the uninformed individual may wonder what the difference is between that and the ISO 9000 series of standards. While it is true that ISO 9001 is mentioned in the context of complying with ISO/IEC 17025, there are several differences, though the critical concept of quality management is found in both. Let's first talk about what ISO 9001 and the 9000 series are geared to do and how they address quality management.
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| The ISO 9000 family of standards addresses the fundamentals of QMSs for an organization<ref name="TsimAnAdapt02">{{cite journal |title=An adaptation to ISO 9001:2000 for certified organisations |journal=Managerial Auditing Journal |author=Tsim, Y.; Yeung, V.; Leung, E. |volume=17 |issue=5 |pages=245–50 |year=2002 |doi=10.1108/02686900210429669}}</ref>, including the eight management principles on which the family of standards is based.<ref name="TsimAnAdapt02" /><ref name="BeattieImplem10">{{cite journal |title=Implementing ISO 9000: A study of its benefits among Australian organizations |journal=Total Quality Management |author=Beattie, K.R. |volume=10 |issue=1 |pages=95–106 |year=2010 |doi=10.1080/0954412998090}}</ref> ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.<ref>{{cite web |url=https://www.iso.org/standard/62085.html |title=ISO 9001:2015 Quality management systems — Requirements |publisher=International Organization for Standardization |date=September 2015 |accessdate=20 January 2023}}</ref> In turn, third-party certification bodies provide independent confirmation that organizations wishing to adhere to the standard meet the requirements of the standard.
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| Quality management is defined by ISO 9000 as a set of "coordinated activities to direct and control an organization with regard to quality.” By extension, those coordinated activities require sufficient "organizational structure, resources, processes and procedures" in order to implement quality management throughout the enterprise, otherwise known as a quality system.<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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| Note that the discussion so far has focused on how the standard addresses the "organization" seeking to improve quality. That's because ISO 9001 is directed at all kinds of organizations operating in any type of industry and sector, whereas ISO/IEC 17025 specifically targets testing, calibration, and sampling laboratories. There are other differences from ISO/IEC 17025 as well, the most significant being that ISO 9001 deals strictly with deploying a QMS in the organization, whereas ISO/IEC 17025 expands into a toolbox of requirements for ensuring not only quality but also the "competence, impartiality, and consistent operation of laboratories."<ref name="ISO17025_17" />
| | The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows: |
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| Finally, accrediting to either of the two standards is also a different process, which highlights the inherent differences between the two standards. As laboratory consultancy Perry Johnson Consulting notes, the difference between the ISO/IEC 17025:2017 and ISO 9001:2015 standards can be found in comparing the accreditation process: "ISO/IEC 17025:2017 accreditation is recognition of a laboratory’s competence to produce technically valid results, while ISO 9001:2015 registration of a laboratory is limited to QMS conformance."<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=20 January 2023}}</ref> They add that ISO/IEC 17025:2017's "technical competency requirements go beyond QMS registration and relate specifically to the qualifications needed with regard to personnel, equipment, facilities, and laboratory methods."<ref name="PJC17025_22" />
| | :[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]] |
| | ::1.1 Materials testing labs, then and now |
| | :::1.1.1 Materials testing 2.0 |
| | ::1.2 Industries, products, and raw materials |
| | ::1.3 Laboratory roles and activities in the industry |
| | :::1.3.1 R&D roles and activities |
| | :::1.3.2 Pre-manufacturing and manufacturing roles and activities |
| | :::1.3.3 Post-production quality control and regulatory roles and activities |
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| From this, we may be tempted to conclude that—at least for the non-clinical laboratory (non-clinical because the clinical lab usually turns to [[ISO 15189|ISO 15189:2022]] ''Medical laboratories — Requirements for quality and competence'')—ISO/IEC 17025 is the quality management standard to comply with, end of story. However, the utility of ISO 9001 to the laboratory should not be completely dismissed. For those struggling with implementing the management system portion of ISO/IEC 17025, additional inspiration and guidance may be found in ISO 9001. For example, ISO 9001:2015 provides additional scope in establishing a QMS, particularly through identifying problematic issues and important stakeholders. It also expands discussion about the importance of organizational leadership establishing quality policy and the organization developing quality objectives, as well as the greater need for identifying organizational knowledge and fully implementing monitoring and measurement mechanisms.<ref name="HammarISO19">{{cite web |url=https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/ |title=ISO 17025 vs. ISO 9001 – Main differences and similarities |author=Hammar, M. |work=Advisera Blog |publisher=Advisera |date=11 July 2019 |accessdate=20 January 2023}}</ref> From this, the laboratory may gain additional benefits by supplementing their ISO/IEC 17025:2017 compliance with some aspects of ISO 9001:2015, further enabling a more [[Risk management|risk-based approach]] to managing quality in the lab.<ref name="HammarISO19" /> (For more about how the laboratory benefits from ISO/IEC 17025:2017, see [[LIMS FAQ:How does ISO/IEC 17025 impact laboratories?|How does ISO/IEC 17025 impact laboratories?]].)
| | :[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]] |
| | ::2.1 Globally recognized materials manufacturing standards |
| | :::2.1.1 American Society of Civil Engineers (ASCE) materials standards |
| | :::2.1.2 ASTM International Volume 15.04 |
| | :::2.1.3 Canadian Standards Association (CSA) A3000 series |
| | :::2.1.4 International Organization for Standardization (ISO) 10993 |
| | :::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family |
| | ::2.2 Regulations and laws around the world |
| | :::2.2.1 21 CFR Part 175 and 176 - United States |
| | :::2.2.2 Building Standard Law - Japan |
| | :::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom |
| | :::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia |
| | :::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada |
| | ::2.3 Standardized test methods for materials |
| | ::2.4 Materials laboratory accreditation |
| | :::2.4.1 A note about engineering and construction materials testing |
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| | :[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]] |
| | ::3.1 Evaluation and selection |
| | :::3.1.1 Technology considerations |
| | ::::3.1.1.1 Laboratory informatics options |
| | :::3.1.2 Features and functions |
| | ::::3.1.2.1 Base features |
| | ::::3.1.2.2 Specialty features |
| | :::3.1.3 Cybersecurity considerations |
| | :::3.1.4 Regulatory compliance considerations |
| | :::3.1.5 System flexibility |
| | :::3.1.6 Cost considerations |
| | ::3.2 Implementation |
| | :::3.2.1 Internal and external integrations |
| | ::3.3 MSW, updates, and other contracted services |
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
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| ===1.3 How we benefit from ISO/IEC 17025 laboratories===
| | :[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]] |
| 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 ''[[LII:The Laboratories of Our Lives: Labs, Labs Everywhere!|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<ref name="DouglasLabs22">{{cite web |url=https://www.limswiki.org/index.php/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!/Laboratories:_A_historical_perspective |title=1. Laboratories: A historical perspective |work=The Laboratories of Our Lives: Labs, Labs Everywhere! |author=Douglas, S.E. |publisher=LIMSwiki |date=July 2022 |accessdate=20 January 2023}}</ref>:
| | ::4.1 LIMS vendors |
| | ::4.2 Consultants |
| | ::4.3 Professional |
| | :::4.3.1 Trade organizations |
| | :::4.3.2 Conferences and trade shows |
| | ::4.4 LIMSpec |
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| <blockquote>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.</blockquote>
| | :[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]] |
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| | ::5.3 Respond to or open dialogue with vendors |
| | :::5.3.1 The value of demonstrations |
| | ::5.4 Finalize the requirements specification and choose a vendor |
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| 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.<ref name="ArgonneOurImpact">{{cite web |url=https://www.anl.gov/argonne-impacts/illinois |title=Argonne Impacts State by State: Illinois |work=Argonne National Laboratory |publisher=UChicago Argonne, LLC |accessdate=20 January 2023}}</ref> 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).<ref name="GertnerTheIdea13">{{cite book |url=https://books.google.com/books?id=OkECDAAAQBAJ |title=The Idea Factory: Bell Labs and the Great Age of American Innovation |author=Gertner, J. |publisher=Penguin |year=2013 |pages=422 |isbn=9780143122791}}</ref> In fact, laboratories are often at the heart of a company's R&D efforts towards bringing people new products. Vehicle<ref name="VolvoMaterials">{{cite web |url=http://www.volvogroup.com/en-en/about-us/r-d-and-innovations/materials-technology.html |archiveurl=https://web.archive.org/web/20170629222307/http://www.volvogroup.com/en-en/about-us/r-d-and-innovations/materials-technology.html |title=Materials Technology |work=Volvo Group |publisher=AB Volvo |archivedate=29 June 2017 |accessdate=20 January 2023}}</ref> and makeup<ref name="LOrealUSAResearch">{{cite web |url=http://www.lorealusa.com/group/discover-l%27or%C3%A9al-usa/l%E2%80%99or%C3%A9al-usa-research-and-innovation |archiveurl=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 |title=L’Oréal USA Research And Innovation |publisher=L’Oréal Group |archivedate=21 October 2018 |accessdate=20 January 2023}}</ref> 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 science#The forensic laboratory|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.
| | :[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]] |
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| However, labs can and do fail (completely, or at their tasks)<ref name="AhujaWhy19">{{cite web |url=https://hbr.org/2019/07/why-innovation-labs-fail-and-how-to-ensure-yours-doesnt |title=Why Innovation Labs Fail, and How to Ensure Yours Doesn’t |author=Ahuja, S.B. |work=Harvard Business Review |date=22 July 2019 |accessdate=20 January 2023}}</ref><ref name="KeppelErrors20">{{Cite journal |last=Keppel |first=Martin H |last2=Cadamuro |first2=Janne |last3=Haschke-Becher |first3=Elisabeth |last4=Oberkofler |first4=Hannes |last5=Felder |first5=Thomas K |last6=Lippi |first6=Giuseppe |last7=Mrazek |first7=Cornelia |date=2020-06-15 |title=Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions |url=https://www.biochemia-medica.com/en/journal/30/2/10.11613/BM.2020.020502 |journal=Biochemia medica |volume=30 |issue=2 |pages=215–233 |doi=10.11613/BM.2020.020502 |pmc=PMC7271754 |pmid=32550813}}</ref><ref name="ParvinMonit15">{{cite web |url=https://www.qcnet.com/resources/qc-articles/learning-from-laboratory-failures |title=Monitoring test system failures and QC performance can help identify opportunities for improvement |author=Parvin, C.A.; Yundt-Pacheco, J.; Quintenz, A. |work=QCNet |date=2015 |accessdate=20 January 2023}}</ref>, like any other business. This can happen for a number of reasons<ref name="AhujaWhy19" /><ref name="KeppelErrors20" />, though insufficient attention to risk and quality management is usually a major contributor.<ref name="ParvinMonit15" /><ref>{{Cite book |last=Mortimer |first=Sharon T. |last2=Mortimer |first2=David |date=2015 |title=Quality and risk management in the IVF laboratory |chapter=Chapter 4: What is risk? |edition=Second edition |publisher=Cambridge University Press |place=Cambridge, United Kingdom ; New York |pages=39–48 |isbn=978-1-107-42128-8}}</ref><ref name="MurrayRisk16">{{cite web |url=https://clpmag.com/lab-essentials/quality-systems/exploring-risk-management-lab/ |title=Exploring Risk Management in the Lab: Risk-based decisionmaking and appropriate analytical tools can improve lab quality |author=Murray, W. |work=CLP Magazine |date=10 May 2016 |accessdate=20 January 2023}}</ref> 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.
| | :[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| | | ::A1. Introduction and methodology |
| 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 [[Clinical laboratory|medical laboratory]] as it is for manufacturing and industry," states the [[World Health Organization]] (WHO) in its 2011 ''Laboratory Quality Management System: Handbook''.<ref name="WHOLQMS11" /> 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.
| | ::A2. Primary laboratory workflow |
| | | ::A3. Maintaining laboratory workflow and operations |
| Past research has shown that a well-implemented quality plan, paired with quality indicators, is significantly associated with improving laboratory services and client satisfaction.<ref>{{Cite journal |last=Mulleta |first=Daba |last2=Jaleta |first2=Fraol |last3=Banti |first3=Haile |last4=Bekele |first4=Bayissa |last5=Abebe |first5=Wake |last6=Tadesse |first6=Henok |last7=Eshetu |first7=Legesse |last8=Zewdu |first8=Adinew |last9=Botore |first9=Abera |last10=Tadesse |first10=Lamessa |last11=Debela |first11=Tessema |date=2021-07 |title=The Impact of Laboratory Quality Management System Implementation on Quality Laboratory Service Delivery in Health Center Laboratories of Oromia Region, Ethiopia |url=https://www.dovepress.com/the-impact-of-laboratory-quality-management-system-implementation-on-q-peer-reviewed-fulltext-article-PLMI |journal=Pathology and Laboratory Medicine International |language=en |volume=Volume 13 |pages=7–19 |doi=10.2147/PLMI.S314656 |issn=1179-2698}}</ref> 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."<ref name="UdohTheImpact17">{{cite web |url=https://www.iaeng.org/publication/WCE2017/WCE2017_pp738-743.pdf |format=PDF |title=The Impact of Quality Management System in Laboratory Certification of Smartcards and Emerging Payment Technologies |author=Udoh, N.; Eluwole, O.T. |work=Proceedings of the World Congress on Engineering 2017, Volume II |isbn=978-988-14048-3-1 |date=July 2017 |accessdate=20 January 2023}}</ref> By extension, the end user of a product or service will be not only more satisfied but also safer for it.
| | ::A4. Specialty laboratory functions |
| | | ::A5. Technology and performance improvements |
| 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.<ref name="HeathmanWeFinal17">{{cite web |url=https://www.wired.co.uk/article/galaxy-note-7-issues-what-happened |title=We finally know why Samsung's Galaxy Note 7s 'exploded' |author=Heathman, A. |work=Wired |date=24 January 2017 |accessdate=20 January 2023}}</ref> 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."<ref name="UdohTheImpact17" /> 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.<ref name="WHOLabQual">{{cite web |url=https://extranet.who.int/hslp/who-hslp-download/package/501/material/168 |format=PDF |title=Module 1, Overview of the Quality System, Introduction |author=World Health Organization |pages=1–9 |accessdate=20 January 2023}}</ref> 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.<ref>{{Cite journal |last=Spink |first=John |last2=Moyer |first2=Douglas C. |last3=Park |first3=Hyeonho |last4=Wu |first4=Yongning |last5=Fersht |first5=Victor |last6=Shao |first6=Bing |last7=Hong |first7=Miao |last8=Paek |first8=Seung Yeop |last9=Edelev |first9=Dmitry |date=2015-12 |title=Introducing Food Fraud including translation and interpretation to Russian, Korean, and Chinese languages |url=https://linkinghub.elsevier.com/retrieve/pii/S0308814614014824 |journal=Food Chemistry |language=en |volume=189 |pages=102–107 |doi=10.1016/j.foodchem.2014.09.106}}</ref>
| | ::A6. Security and integrity of systems and operations |
| | | ::A7. Putting those requirements to practical use and caveats |
| Quality management also improves overall costs and efficiency for not only the laboratory but also society.<ref>{{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><ref name="GarberAGuide21">{{cite web |url=https://www.garbermetrology.com/iso-17025/ |title=A Guide to ISO 17025 Calibration and Compliance |author=Garber Metrology |work=Garber Metrology Blog |date=14 December 2021 |accessdate=20 January 2023}}</ref><ref name="AdviseraWhatIs22">{{cite web |url=https://advisera.com/17025academy/what-is-iso-17025/ |title=What is ISO 17025? |publisher=Advisera Expert Solutions Ltd |date=2022 |accessdate=20 January 2023}}</ref><ref name="RaibornTQM96">{{Cite journal |last=Raiborn |first=Cecily |last2=Payne |first2=Dinah |date=1996-09 |title=TQM: Just what the ethicist ordered |url=http://link.springer.com/10.1007/BF00705576 |journal=Journal of Business Ethics |language=en |volume=15 |issue=9 |pages=963–972 |doi=10.1007/BF00705576 |issn=0167-4544}}</ref> Raiborn and Payne noted this in the mid-1990s while discussing the topic of "total quality management"<ref name="RaibornTQM96" />:
| | ::A8. LIMSpec in Microsoft Word format |
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| <blockquote>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.).</blockquote>
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| 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.
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| ==References==
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