Quality management system - Revision history

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	[[Category:~~Business and data~~ management]]		[[Category:Quality management]]
	[[Category:Software systems]]		[[Category:Software systems]]

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			[[Category:Business and data management]]
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Shawndouglas: /* Certifications and awards */ Fixed a broken citation

2022-08-16T18:12:29Z

Certifications and awards: Fixed a broken citation

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	Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e., planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis.<ref name="LazarteISO9001_15">{{cite web \|url=https://www.iso.org/news/2015/09/Ref2002.html \|title=SO 9001:2015 - Just published! \|author=Lazarte, M. \|work=ISO News \|publisher=International Organization for Standardization \|date=23 September 2015 \|accessdate=21 November 2017}}</ref>		Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e., planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis.<ref name="LazarteISO9001_15">{{cite web \|url=https://www.iso.org/news/2015/09/Ref2002.html \|title=SO 9001:2015 - Just published! \|author=Lazarte, M. \|work=ISO News \|publisher=International Organization for Standardization \|date=23 September 2015 \|accessdate=21 November 2017}}</ref>

	In the U.S., the national Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.<ref name="NISTBaldridge16">{{cite web \|url=https://www.nist.gov/baldrige/how-baldrige-works \|title=How Baldridge Works \|work=Baldrige Performance Excellence Program \|publisher=National Institute of Standards and Technology \|date=20 July 2016 \|accessdate=21 November 2017}}</ref> Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.<ref name="BaldrigeAPE">{{cite web \|url=https://www.baldrigealliance.org/ \|title=The Alliance for Performance Excellence \|publisher=Baldrige Foundation \|date=2020 \|accessdate=07 January 2022}</ref>		In the U.S., the national Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.<ref name="NISTBaldridge16">{{cite web \|url=https://www.nist.gov/baldrige/how-baldrige-works \|title=How Baldridge Works \|work=Baldrige Performance Excellence Program \|publisher=National Institute of Standards and Technology \|date=20 July 2016 \|accessdate=21 November 2017}}</ref> Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.<ref name="BaldrigeAPE">{{cite web \|url=https://www.baldrigealliance.org/ \|title=The Alliance for Performance Excellence \|publisher=Baldrige Foundation \|date=2020 \|accessdate=07 January 2022}}</ref>

	Since 1984, Canada's National Quality Institute has presented the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness and have met the institute's criteria with documented overall achievements and results.<ref name="ECCanadaAwards">{{cite web \|url=https://excellence.ca/canada-awards-for-excellence/ \|title=Canada Awards for Excellence \|publisher=Excellence Canada \|date=2016 \|accessdate=07 January 2022}}</ref>		Since 1984, Canada's National Quality Institute has presented the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness and have met the institute's criteria with documented overall achievements and results.<ref name="ECCanadaAwards">{{cite web \|url=https://excellence.ca/canada-awards-for-excellence/ \|title=Canada Awards for Excellence \|publisher=Excellence Canada \|date=2016 \|accessdate=07 January 2022}}</ref>

Shawndouglas: Spacing

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Spacing

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	* {{cite web \|url=https://www.praxiom.com/iso-9001.htm \|title=ISO 9001 Translated Into Plain English \|author=Praxiom Research Group Limited \|publisher=Praxiom Research Group Limited \|date=16 August 2017}}		* {{cite web \|url=https://www.praxiom.com/iso-9001.htm \|title=ISO 9001 Translated Into Plain English \|author=Praxiom Research Group Limited \|publisher=Praxiom Research Group Limited \|date=16 August 2017}}
	* {{cite book \|url=https://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011}}		* {{cite book \|url=https://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011}}

	==Notes==		==Notes==
	This article reuses a few elements from [https://en.wikipedia.org/wiki/Quality_management_system the Wikipedia article].		This article reuses a few elements from [https://en.wikipedia.org/wiki/Quality_management_system the Wikipedia article].

Shawndouglas: Updated URLs for 2022

2022-01-07T23:08:06Z

Updated URLs for 2022

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Shawndouglas: /* History */ More grammar

2021-05-23T20:26:50Z

History: More grammar

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	==History==		==History==
	The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking ~~the~~ product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality ~~with~~ its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>		The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking of a product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production, where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality due to its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>

	In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>		In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, in turn limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>

	Post World War II saw statistician and mathematician William Edwards Deming (after whom the Deming Prize for quality is named), the father of the quality management movement, develop a theory of quality management that focused on the "joy in work," while placing emphasis on quality at each step of a process, not simply on the final inspection.<ref name="GitlowQuality00">{{cite book \|url=https://books.google.com/books?id=O5aq0HMyXOcC&pg=PA1 \|title=Quality Management Systems: A Practical Guide \|author=Gitlow, H.S. \|publisher=CRC Press \|pages=296 \|year=2000 \|isbn=9781574442618}}</ref> This led to several Japanese scientists and engineers inviting Deming to Japan in 1950 to share his ideas on statistical methods towards improved quality, with several companies seeing productivity and profit gains after adoption.<ref name="GitlowQuality00" /> In 1951, engineer and management consultant Joseph M. Juran published the first edition of ''Juran's Quality Handbook'', an influential guide to quality management that focused on "fitness for use by the customer" as a goal of quality. Juran's work, focusing on management's influence on quality, had a similar impact on the Japanese. The combination of Deming's and Juran's influence ultimately led to the Japanese developing their own take on quality management: Japanese Total Quality Control.<ref name="GitlowQuality00" />		Post World War II saw statistician and mathematician William Edwards Deming (after whom the Deming Prize for quality is named), the father of the quality management movement, develop a theory of quality management that focused on the "joy in work," while placing emphasis on quality at each step of a process, not simply on the final inspection.<ref name="GitlowQuality00">{{cite book \|url=https://books.google.com/books?id=O5aq0HMyXOcC&pg=PA1 \|title=Quality Management Systems: A Practical Guide \|author=Gitlow, H.S. \|publisher=CRC Press \|pages=296 \|year=2000 \|isbn=9781574442618}}</ref> This led to several Japanese scientists and engineers inviting Deming to Japan in 1950 to share his ideas on statistical methods towards improved quality, with several companies seeing productivity and profit gains after adoption.<ref name="GitlowQuality00" /> In 1951, engineer and management consultant Joseph M. Juran published the first edition of ''Juran's Quality Handbook'', an influential guide to quality management that focused on "fitness for use by the customer" as a goal of quality. Juran's work, focusing on management's influence on quality, had a similar impact on the Japanese. The combination of Deming's and Juran's influence ultimately led to the Japanese developing their own take on quality management: Japanese Total Quality Control.<ref name="GitlowQuality00" />

	In the mid-twentieth century, the focus on quality as a ~~profession~~ and a managerial process saw the quality profession grow from simple engineering controls to systems engineering that took quality into account at its various steps. This was most noticeable in the Japanese strategy to industry, though the U.S. didn't clearly recognize it until the early 1980s. With the decline in price competition and increase in quality competition in the 1970's putting American manufacturing in a difficult position, the early to mid-1980s saw the U.S.' industrial and government leaders recognize Japan's quality strategy<ref name="ASQTotal">{{cite web \|url=http://asq.org/learn-about-quality/history-of-quality/overview/total-quality.html \|title=Total Quality \|work=Learn About Quality \|publisher=American Society for Quality \|accessdate=27 October 2017}}</ref>, committing to a renewed emphasis on quality in order to stay relevant in an expanding and competitive world market. The [[Malcolm Baldrige National Quality Improvement Act of 1987]] spawned the associated National Quality Program, commonly referred to as the Baldridge model<ref name="Rocha-LonaBuilding13" />, and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the [[ISO 9000\|ISO 9001, 9002, and 9003]] standards were published; based off work from previous British and U.S. military standards, the ~~standard~~ sought to "provide organizations with the requirements to create a quality management system (QMS) for a range of different business activities."<ref name="QMSIntISO16">{{cite web \|url=https://www.qmsuk.com/news/iso-9002-and-9003-is-iso-9001-a-suitable-replacement \|title=ISO 9002 and 9003: Is ISO 9001 a suitable replacement? \|publisher=QMS International \|date=09 December 2017 \|accessdate=02 November 2017}}</ref> Other awards like the Deming Prize were set up by the Japanese, and the first non-Japanese company to win the prize was the U.S.'s Florida Light and Power in 1989.<ref name="ColeManaging99">{{cite book \|url=https://books.google.com/books?id=uBN7CYnaT74C&pg=PA67 \|chapter=Chapter 3: How Much Did You Know and When Did You Know It? \|title=Managing Quality Fads: How American Business Learned to Play the Quality Game \|author=Cole, R.E. \|publisher=Oxford University Press \|pages=63–81 \|year=1999 \|isbn=9780198028604}}</ref> The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.<ref name="Rocha-LonaBuilding13" />		In the mid-twentieth century, the focus on quality as a professional and a managerial process saw the quality profession grow from simple engineering controls to systems engineering that took quality into account at its various steps. This was most noticeable in the Japanese strategy to industry, though the U.S. didn't clearly recognize it until the early 1980s. With the decline in price competition and increase in quality competition in the 1970's putting American manufacturing in a difficult position, the early to mid-1980s saw the U.S.' industrial and government leaders recognize Japan's quality strategy<ref name="ASQTotal">{{cite web \|url=http://asq.org/learn-about-quality/history-of-quality/overview/total-quality.html \|title=Total Quality \|work=Learn About Quality \|publisher=American Society for Quality \|accessdate=27 October 2017}}</ref>, committing to a renewed emphasis on quality in order to stay relevant in an expanding and competitive world market. The [[Malcolm Baldrige National Quality Improvement Act of 1987]] spawned the associated National Quality Program, commonly referred to as the Baldridge model<ref name="Rocha-LonaBuilding13" />, and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the [[ISO 9000\|ISO 9001, 9002, and 9003]] standards were published; based off work from previous British and U.S. military standards, the standards sought to "provide organizations with the requirements to create a quality management system (QMS) for a range of different business activities."<ref name="QMSIntISO16">{{cite web \|url=https://www.qmsuk.com/news/iso-9002-and-9003-is-iso-9001-a-suitable-replacement \|title=ISO 9002 and 9003: Is ISO 9001 a suitable replacement? \|publisher=QMS International \|date=09 December 2017 \|accessdate=02 November 2017}}</ref> Other awards like the Deming Prize were set up by the Japanese, and the first non-Japanese company to win the prize was the U.S.'s Florida Light and Power in 1989.<ref name="ColeManaging99">{{cite book \|url=https://books.google.com/books?id=uBN7CYnaT74C&pg=PA67 \|chapter=Chapter 3: How Much Did You Know and When Did You Know It? \|title=Managing Quality Fads: How American Business Learned to Play the Quality Game \|author=Cole, R.E. \|publisher=Oxford University Press \|pages=63–81 \|year=1999 \|isbn=9780198028604}}</ref> The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.<ref name="Rocha-LonaBuilding13" />

	By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.<ref name="QMSIntISO16" /> At least 150 countries adopted the ISO 9000 standards by the end of 1999, with the associated third-party registration industry having a total economic impact of $4 billion. ~~That~~ number had climbed to 161 ~~countries~~ by the summer of 2002<ref name="SchlickmanISO09001_03b">{{cite book \|url=https://books.google.com/books?id=FkQB4GRB7uwC \|title=ISO 9001:2000 Quality Management System Design \|author=Schlickman, J.J. \|publisher=Artech House \|page=xxii \|year=2003 \|isbn=9781580535960}}</ref>, after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.<ref name="QMSIntISO16" /> Changes in 2008 were minor, but the 2015 revision saw major revisions in structure and how common requirements were aligned with other relevant standards, with more of a focus on risk-based thinking.<ref name="QMSIntISO16" />		By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.<ref name="QMSIntISO16" /> At least 150 countries adopted the ISO 9000 standards by the end of 1999, with the associated third-party registration industry having a total economic impact of $4 billion. The number of adopting countries had climbed to 161 by the summer of 2002<ref name="SchlickmanISO09001_03b">{{cite book \|url=https://books.google.com/books?id=FkQB4GRB7uwC \|title=ISO 9001:2000 Quality Management System Design \|author=Schlickman, J.J. \|publisher=Artech House \|page=xxii \|year=2003 \|isbn=9781580535960}}</ref>, after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.<ref name="QMSIntISO16" /> Changes in 2008 were minor, but the 2015 revision saw major revisions in structure and how common requirements were aligned with other relevant standards, with more of a focus on risk-based thinking.<ref name="QMSIntISO16" />

	==QMS standards and elements==		==QMS standards and elements==

Shawndouglas: /* History */ Grammar

2021-05-23T20:21:26Z

History: Grammar

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	==History==		==History==
	The concept of a "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality with its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>		The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality with its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>

	In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>		In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>

Shawndouglas: /* Special cases */ Internal links

2018-02-02T20:22:54Z

Special cases: Internal links

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	==Special cases==		==Special cases==
	===Laboratories===		===Laboratories===
	Several guidelines apply to laboratories, whether they conduct testing, calibration, or other activities. The most commonly used standard that discusses the use of a quality management system is ISO/IEC 17025. Originally focused on calibration and testing activities, a revised version of the standard is set to be published at the end of 2017 with a broader scope of all laboratory activities.<ref name="TranchardISOIEC17" /> The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories<ref name="RobinsQuality06">{{cite journal \|title=Quality assurance in research laboratories \|journal=Accreditation and Quality Assurance \|author=Robins, M.M.; Scarll, S.J.; Key, P.E. \|volume=11 \|issue=5 \|pages=214–223 \|year=2006 \|doi=10.1007/s00769-006-0129-5}}</ref>), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.<ref name="TranchardISOIEC17" /> ISO/IEC 17025 essentially lays out the management and technical requirements for a laboratories quality management system and how it should be implemented and assessed.<ref name="PetersDeveloping16">{{cite web \|url=https://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf \|format=PDF \|title=Developing and Maintaining a Laboratory Quality Management System - Version 3.0 \|author=Peters, R.H. \|publisher=American Industrial Hygiene Association \|date=2016 \|pages=175 \|accessdate=09 November 2017}}</ref>		Several guidelines apply to [[Laboratory\|laboratories]], whether they conduct [[Test method\|testing]], [[Reference laboratory#Reference measurement and calibration\|calibration]], or other activities. The most commonly used standard that discusses the use of a quality management system is ISO/IEC 17025. Originally focused on calibration and testing activities, a revised version of the standard is set to be published at the end of 2017 with a broader scope of all laboratory activities.<ref name="TranchardISOIEC17" /> The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories<ref name="RobinsQuality06">{{cite journal \|title=Quality assurance in research laboratories \|journal=Accreditation and Quality Assurance \|author=Robins, M.M.; Scarll, S.J.; Key, P.E. \|volume=11 \|issue=5 \|pages=214–223 \|year=2006 \|doi=10.1007/s00769-006-0129-5}}</ref>), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.<ref name="TranchardISOIEC17" /> ISO/IEC 17025 essentially lays out the management and technical requirements for a laboratories quality management system and how it should be implemented and assessed.<ref name="PetersDeveloping16">{{cite web \|url=https://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf \|format=PDF \|title=Developing and Maintaining a Laboratory Quality Management System - Version 3.0 \|author=Peters, R.H. \|publisher=American Industrial Hygiene Association \|date=2016 \|pages=175 \|accessdate=09 November 2017}}</ref>

	Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and continual improvement.<ref name="FlynnISO11">{{cite web \|url=https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|archiveurl=https://web.archive.org/web/20171110000425/https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|title=ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System \|author=Flynn, G.J.; Coffey, J. \|editor=Michel, R.L.; Khanna, P. \|publisher=Dark Intelligence Group, Inc \|date=2011 \|archivedate=09 November 2017 \|accessdate=09 November 2017}}</ref> Also related is the Clinical and Laboratory Standards Institute's (CLSI) GP26-A3 and HS1-A2 standards on quality management system models, which offer 12 quality system essentials and are compatible with the associated ISO standards.<ref name="WHOLaboratory11">{{cite book \|url=http://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011 \|accessdate=21 November 2017}}</ref>		Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and continual improvement.<ref name="FlynnISO11">{{cite web \|url=https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|archiveurl=https://web.archive.org/web/20171110000425/https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|title=ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System \|author=Flynn, G.J.; Coffey, J. \|editor=Michel, R.L.; Khanna, P. \|publisher=Dark Intelligence Group, Inc \|date=2011 \|archivedate=09 November 2017 \|accessdate=09 November 2017}}</ref> Also related is the Clinical and Laboratory Standards Institute's (CLSI) GP26-A3 and HS1-A2 standards on quality management system models, which offer 12 quality system essentials and are compatible with the associated ISO standards.<ref name="WHOLaboratory11">{{cite book \|url=http://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011 \|accessdate=21 November 2017}}</ref>
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	The two primary guidelines for [[medical device]] manufacturer quality management systems in the United States are the ISO 13485 standard and the U.S. Food and Drug Administration's (FDA) 21 CFR Part 820 regulations. The two have a great deal of similarity, and many manufacturers adopt a QMS that is compliant with both guidelines. Outside the U.S., ISO 13485 has synergies with the European Union medical devices directives (93/42/EEC and 90/385/EEC; superseded by Regulation (EU) 2017/745 in May 2017<ref name="ECRegFrame17">{{cite web \|url=https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en \|title=Medical Devices: Regulatory Framework \|publisher=European Commission \|date=11 September 2017 \|accessdate=09 November 2017}}</ref>) as well as the in vitro diagnostic medical device directive (98/79/EC and 2010/227/EU; superseded by Regulation (EU) 2017/746 in May 2017<ref name="ECRegFrame17" />). The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).		The two primary guidelines for [[medical device]] manufacturer quality management systems in the United States are the ISO 13485 standard and the U.S. Food and Drug Administration's (FDA) 21 CFR Part 820 regulations. The two have a great deal of similarity, and many manufacturers adopt a QMS that is compliant with both guidelines. Outside the U.S., ISO 13485 has synergies with the European Union medical devices directives (93/42/EEC and 90/385/EEC; superseded by Regulation (EU) 2017/745 in May 2017<ref name="ECRegFrame17">{{cite web \|url=https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en \|title=Medical Devices: Regulatory Framework \|publisher=European Commission \|date=11 September 2017 \|accessdate=09 November 2017}}</ref>) as well as the in vitro diagnostic medical device directive (98/79/EC and 2010/227/EU; superseded by Regulation (EU) 2017/746 in May 2017<ref name="ECRegFrame17" />). The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).

	According to current good manufacturing practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply relevant sections standards, regulations, and guidelines that are applicable to their specific products and operations. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.		According to current [[good manufacturing practice]] (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply relevant sections standards, regulations, and guidelines that are applicable to their specific products and operations. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

	Because the FDA's 21 CFR Part 820 regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left up to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then it's not necessary for the manufacturer to comply with all of the GMP requirements under device labeling.		Because the FDA's 21 CFR Part 820 regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left up to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then it's not necessary for the manufacturer to comply with all of the GMP requirements under device labeling.

Shawndouglas: /* QMS elements */ Internal link.

2018-02-02T20:15:35Z

QMS elements: Internal link.

← Older revision		Revision as of 20:15, 2 February 2018
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	* quality manual		* quality manual
	* set of procedures, instructions, and records		* set of procedures, instructions, and records
	* data management		* [[Information management\|data management]]
	* internal processes		* internal processes
	* product/service quality that leads to customer satisfaction		* product/service quality that leads to customer satisfaction

Shawndouglas: Continuous to continual and internal link

2017-12-06T22:19:23Z

Continuous to continual and internal link

← Older revision		Revision as of 22:19, 6 December 2017
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	* product/service quality that leads to customer satisfaction		* product/service quality that leads to customer satisfaction
	* quality analysis		* quality analysis
	* ~~continuous~~ improvement, including corrective and preventive action		* [[Continual improvement process\|continual improvement]], including corrective and preventive action

	====Quality policy and objectives====		====Quality policy and objectives====
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	====Quality manual====		====Quality manual====
	A quality manual is the first set of documentation primary to a QMS, and it's used to communicate management's expectations towards quality, how to conform to them, and how to measure that conformity. The manual typically contains a full description of the QMS, describing the standard-based requirements, quality procedures, exclusions, interactions, and granular quality policies. A successful quality manual further guides a business towards ~~continuous~~ improvement.<ref name="PayneISO9001">{{cite web \|url=https://asq.org/quality-resources/iso-9001-quality-manual \|title=ISO 9001 Quality Manual \|author=Payne, G.C. \|publisher=American Society for Quality \|accessdate=09 November 2017}}</ref><ref name="ISO9000QM">{{cite web \|url=http://the9000store.com/articles/iso-9000-tips-what-is-a-quality-manual/ \|title=What is an ISO 9001 Quality Manual? \|work=9000 Store \|publisher=Standards Stores \|accessdate=09 November 2017}}</ref>		A quality manual is the first set of documentation primary to a QMS, and it's used to communicate management's expectations towards quality, how to conform to them, and how to measure that conformity. The manual typically contains a full description of the QMS, describing the standard-based requirements, quality procedures, exclusions, interactions, and granular quality policies. A successful quality manual further guides a business towards continual improvement.<ref name="PayneISO9001">{{cite web \|url=https://asq.org/quality-resources/iso-9001-quality-manual \|title=ISO 9001 Quality Manual \|author=Payne, G.C. \|publisher=American Society for Quality \|accessdate=09 November 2017}}</ref><ref name="ISO9000QM">{{cite web \|url=http://the9000store.com/articles/iso-9000-tips-what-is-a-quality-manual/ \|title=What is an ISO 9001 Quality Manual? \|work=9000 Store \|publisher=Standards Stores \|accessdate=09 November 2017}}</ref>

	====Procedures, instructions, and records====		====Procedures, instructions, and records====
	Quality procedures don't have a set format but should include a series of consistent elements, including title, purpose, scope, responsible parties, resulting records, document controls, activity descriptions, and appendices. Any instructions should be similarly structured but also include "details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy."<ref name="MeskovskaHowTo14">{{cite web \|url=https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/ \|title=How to structure quality management system documentation \|author=Meskovska, A. \|work=ISO 9001 Knowledge Base \|publisher=Advisera Expert Solutions Ltd \|date=23 October 2014 \|accessdate=09 November 2017}}</ref> A record of proofs provide traceability of the various actions taken to comply with those quality procedures and instructions, providing tools for ~~continuous~~ improvement and corrective action.<ref name="BesterfieldTotal11">{{cite book \|chapter=Chapter 10: Quality Management Systems \|title=Total Quality Management \|author=Besterfield, D.H.; Besterfield–Michna, C.; Bestefield, G.H. et al. \|edition=Revised 3rd \|publisher=Pearson Education India \|year=2011 \|pages=205–238 \|isbn=9788131732274}}</ref>		Quality procedures don't have a set format but should include a series of consistent elements, including title, purpose, scope, responsible parties, resulting records, document controls, activity descriptions, and appendices. Any instructions should be similarly structured but also include "details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy."<ref name="MeskovskaHowTo14">{{cite web \|url=https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/ \|title=How to structure quality management system documentation \|author=Meskovska, A. \|work=ISO 9001 Knowledge Base \|publisher=Advisera Expert Solutions Ltd \|date=23 October 2014 \|accessdate=09 November 2017}}</ref> A record of proofs provide traceability of the various actions taken to comply with those quality procedures and instructions, providing tools for continual improvement and corrective action.<ref name="BesterfieldTotal11">{{cite book \|chapter=Chapter 10: Quality Management Systems \|title=Total Quality Management \|author=Besterfield, D.H.; Besterfield–Michna, C.; Bestefield, G.H. et al. \|edition=Revised 3rd \|publisher=Pearson Education India \|year=2011 \|pages=205–238 \|isbn=9788131732274}}</ref>

	====Data management====		====Data management====
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	A major part of a QMS is evaluating and improving processes and procedures to improve overall quality. Part of this process may include defect analysis for products, customer satisfaction analysis for services, and corrective action planning. Also included is overall product testing, tests that, for a product, may measure material, electrical, stressed, etc. characteristics to ensure functionality for the end-user. Even the business' own operations may be scrutinized to identify points in the system where physical or economical impact is most negatively felt.		A major part of a QMS is evaluating and improving processes and procedures to improve overall quality. Part of this process may include defect analysis for products, customer satisfaction analysis for services, and corrective action planning. Also included is overall product testing, tests that, for a product, may measure material, electrical, stressed, etc. characteristics to ensure functionality for the end-user. Even the business' own operations may be scrutinized to identify points in the system where physical or economical impact is most negatively felt.

	====~~Continuous~~ improvement====		====Continual improvement====
	~~Continuous~~ improvement recognizes that customer needs change over time and that an incremental innovation process should always be in place to address those changing needs. "Small steps, high frequency and small change cycles seen separately have small impacts but, added up can bring a significant contribution to the company’s performance."<ref name="ValadãoRelation13">{{cite journal \|title=Relationship between the Maturity of Continuous Improvement and the Certification of Quality Management System in Automotive Sector in Brazil \|journal=Independent Journal of Management & Production \|author=Fatima Chiaradia Valadão, A. de; Silva Campos, P.H. da; Turrioni, J.B. \|volume=4 \|issue=1 \|pages=96–110 \|year=2013 \|doi=10.14807/ijmp.v4i1.61}}</ref> Optimally the idea of ~~continuous~~ improvement should also be promoted by senior leadership, finding its way not only into the quality manual but ultimately also into the work culture.<ref name="ValadãoRelation13" />		Continual improvement recognizes that customer needs change over time and that an incremental innovation process should always be in place to address those changing needs. "Small steps, high frequency and small change cycles seen separately have small impacts but, added up can bring a significant contribution to the company’s performance."<ref name="ValadãoRelation13">{{cite journal \|title=Relationship between the Maturity of Continuous Improvement and the Certification of Quality Management System in Automotive Sector in Brazil \|journal=Independent Journal of Management & Production \|author=Fatima Chiaradia Valadão, A. de; Silva Campos, P.H. da; Turrioni, J.B. \|volume=4 \|issue=1 \|pages=96–110 \|year=2013 \|doi=10.14807/ijmp.v4i1.61}}</ref> Optimally the idea of continual improvement should also be promoted by senior leadership, finding its way not only into the quality manual but ultimately also into the work culture.<ref name="ValadãoRelation13" />

	==Special cases==		==Special cases==
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	Several guidelines apply to laboratories, whether they conduct testing, calibration, or other activities. The most commonly used standard that discusses the use of a quality management system is ISO/IEC 17025. Originally focused on calibration and testing activities, a revised version of the standard is set to be published at the end of 2017 with a broader scope of all laboratory activities.<ref name="TranchardISOIEC17" /> The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories<ref name="RobinsQuality06">{{cite journal \|title=Quality assurance in research laboratories \|journal=Accreditation and Quality Assurance \|author=Robins, M.M.; Scarll, S.J.; Key, P.E. \|volume=11 \|issue=5 \|pages=214–223 \|year=2006 \|doi=10.1007/s00769-006-0129-5}}</ref>), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.<ref name="TranchardISOIEC17" /> ISO/IEC 17025 essentially lays out the management and technical requirements for a laboratories quality management system and how it should be implemented and assessed.<ref name="PetersDeveloping16">{{cite web \|url=https://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf \|format=PDF \|title=Developing and Maintaining a Laboratory Quality Management System - Version 3.0 \|author=Peters, R.H. \|publisher=American Industrial Hygiene Association \|date=2016 \|pages=175 \|accessdate=09 November 2017}}</ref>		Several guidelines apply to laboratories, whether they conduct testing, calibration, or other activities. The most commonly used standard that discusses the use of a quality management system is ISO/IEC 17025. Originally focused on calibration and testing activities, a revised version of the standard is set to be published at the end of 2017 with a broader scope of all laboratory activities.<ref name="TranchardISOIEC17" /> The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories<ref name="RobinsQuality06">{{cite journal \|title=Quality assurance in research laboratories \|journal=Accreditation and Quality Assurance \|author=Robins, M.M.; Scarll, S.J.; Key, P.E. \|volume=11 \|issue=5 \|pages=214–223 \|year=2006 \|doi=10.1007/s00769-006-0129-5}}</ref>), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.<ref name="TranchardISOIEC17" /> ISO/IEC 17025 essentially lays out the management and technical requirements for a laboratories quality management system and how it should be implemented and assessed.<ref name="PetersDeveloping16">{{cite web \|url=https://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf \|format=PDF \|title=Developing and Maintaining a Laboratory Quality Management System - Version 3.0 \|author=Peters, R.H. \|publisher=American Industrial Hygiene Association \|date=2016 \|pages=175 \|accessdate=09 November 2017}}</ref>

	Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and ~~continuous~~ improvement.<ref name="FlynnISO11">{{cite web \|url=https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|archiveurl=https://web.archive.org/web/20171110000425/https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|title=ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System \|author=Flynn, G.J.; Coffey, J. \|editor=Michel, R.L.; Khanna, P. \|publisher=Dark Intelligence Group, Inc \|date=2011 \|archivedate=09 November 2017 \|accessdate=09 November 2017}}</ref> Also related is the Clinical and Laboratory Standards Institute's (CLSI) GP26-A3 and HS1-A2 standards on quality management system models, which offer 12 quality system essentials and are compatible with the associated ISO standards.<ref name="WHOLaboratory11">{{cite book \|url=http://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011 \|accessdate=21 November 2017}}</ref>		Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and continual improvement.<ref name="FlynnISO11">{{cite web \|url=https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|archiveurl=https://web.archive.org/web/20171110000425/https://s3.amazonaws.com/ppt-download/iso15189medicallaboratoriesunderstandingthefourcomponentsofaqualitymanagementsystem-110624141711-phpapp01.pdf?response-content-disposition=attachment&Signature=2XEf%2FLP2tfn4tu2TgmX4pUn2X9w%3D&Expires=1510272516&AWSAccessKeyId=AKIAJ6D6SEMXSASXHDAQ \|title=ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System \|author=Flynn, G.J.; Coffey, J. \|editor=Michel, R.L.; Khanna, P. \|publisher=Dark Intelligence Group, Inc \|date=2011 \|archivedate=09 November 2017 \|accessdate=09 November 2017}}</ref> Also related is the Clinical and Laboratory Standards Institute's (CLSI) GP26-A3 and HS1-A2 standards on quality management system models, which offer 12 quality system essentials and are compatible with the associated ISO standards.<ref name="WHOLaboratory11">{{cite book \|url=http://www.who.int/ihr/publications/lqms_en.pdf \|format=PDF \|title=Laboratory Quality Management System Handbook \|author=World Health Organization \|publisher=World Health Organization \|isbn=9789241548274 \|pages=246 \|year=2011 \|accessdate=21 November 2017}}</ref>

	===Medical device industry===		===Medical device industry===

← Older revision		Revision as of 18:12, 16 August 2022
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	Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e., planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis.<ref name="LazarteISO9001_15">{{cite web \|url=https://www.iso.org/news/2015/09/Ref2002.html \|title=SO 9001:2015 - Just published! \|author=Lazarte, M. \|work=ISO News \|publisher=International Organization for Standardization \|date=23 September 2015 \|accessdate=21 November 2017}}</ref>		Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e., planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis.<ref name="LazarteISO9001_15">{{cite web \|url=https://www.iso.org/news/2015/09/Ref2002.html \|title=SO 9001:2015 - Just published! \|author=Lazarte, M. \|work=ISO News \|publisher=International Organization for Standardization \|date=23 September 2015 \|accessdate=21 November 2017}}</ref>

	In the U.S., the national Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.<ref name="NISTBaldridge16">{{cite web \|url=https://www.nist.gov/baldrige/how-baldrige-works \|title=How Baldridge Works \|work=Baldrige Performance Excellence Program \|publisher=National Institute of Standards and Technology \|date=20 July 2016 \|accessdate=21 November 2017}}</ref> Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.<ref name="BaldrigeAPE">{{cite web \|url=https://www.baldrigealliance.org/ \|title=The Alliance for Performance Excellence \|publisher=Baldrige Foundation \|date=2020 \|accessdate=07 January 2022}</ref>		In the U.S., the national Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.<ref name="NISTBaldridge16">{{cite web \|url=https://www.nist.gov/baldrige/how-baldrige-works \|title=How Baldridge Works \|work=Baldrige Performance Excellence Program \|publisher=National Institute of Standards and Technology \|date=20 July 2016 \|accessdate=21 November 2017}}</ref> Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.<ref name="BaldrigeAPE">{{cite web \|url=https://www.baldrigealliance.org/ \|title=The Alliance for Performance Excellence \|publisher=Baldrige Foundation \|date=2020 \|accessdate=07 January 2022}}</ref>

	Since 1984, Canada's National Quality Institute has presented the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness and have met the institute's criteria with documented overall achievements and results.<ref name="ECCanadaAwards">{{cite web \|url=https://excellence.ca/canada-awards-for-excellence/ \|title=Canada Awards for Excellence \|publisher=Excellence Canada \|date=2016 \|accessdate=07 January 2022}}</ref>		Since 1984, Canada's National Quality Institute has presented the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness and have met the institute's criteria with documented overall achievements and results.<ref name="ECCanadaAwards">{{cite web \|url=https://excellence.ca/canada-awards-for-excellence/ \|title=Canada Awards for Excellence \|publisher=Excellence Canada \|date=2016 \|accessdate=07 January 2022}}</ref>

← Older revision		Revision as of 20:26, 23 May 2021
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	==History==		==History==
	The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking ~~the~~ product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality ~~with~~ its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>		The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking of a product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production, where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality due to its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."<ref name="HendricksonTheEncyclopedia14">{{cite book \|url=https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758 \|chapter=Quality Assurance and Control \|title=The Encyclopedia of the Industrial Revolution in World History \|author=Hendrickson, K.E. \|publisher=Rowman & Littlefield \|volume=3 \|year=2014 \|isbn=9780810888883}}</ref>

	In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>		In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, in turn limiting complexity.<ref name="PappQuality14">{{cite book \|url=https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3 \|title=Quality Management in the Imaging Sciences \|author=Papp, J. \|publisher=Elsevier Health Sciences \|pages=372 \|year=2014 \|isbn=9780323261999}}</ref> Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."<ref name="WoodHenry03">{{cite book \|url=https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300 \|title=Henry Ford: Critical Evaluations in Business and Management \|editor=Wood, J.C.; Wood, M.C. \|publisher=Taylor and Francis \|volume=1 \|pages=384 \|year=2003 \|isbn=9780415248259}}</ref>

	Post World War II saw statistician and mathematician William Edwards Deming (after whom the Deming Prize for quality is named), the father of the quality management movement, develop a theory of quality management that focused on the "joy in work," while placing emphasis on quality at each step of a process, not simply on the final inspection.<ref name="GitlowQuality00">{{cite book \|url=https://books.google.com/books?id=O5aq0HMyXOcC&pg=PA1 \|title=Quality Management Systems: A Practical Guide \|author=Gitlow, H.S. \|publisher=CRC Press \|pages=296 \|year=2000 \|isbn=9781574442618}}</ref> This led to several Japanese scientists and engineers inviting Deming to Japan in 1950 to share his ideas on statistical methods towards improved quality, with several companies seeing productivity and profit gains after adoption.<ref name="GitlowQuality00" /> In 1951, engineer and management consultant Joseph M. Juran published the first edition of ''Juran's Quality Handbook'', an influential guide to quality management that focused on "fitness for use by the customer" as a goal of quality. Juran's work, focusing on management's influence on quality, had a similar impact on the Japanese. The combination of Deming's and Juran's influence ultimately led to the Japanese developing their own take on quality management: Japanese Total Quality Control.<ref name="GitlowQuality00" />		Post World War II saw statistician and mathematician William Edwards Deming (after whom the Deming Prize for quality is named), the father of the quality management movement, develop a theory of quality management that focused on the "joy in work," while placing emphasis on quality at each step of a process, not simply on the final inspection.<ref name="GitlowQuality00">{{cite book \|url=https://books.google.com/books?id=O5aq0HMyXOcC&pg=PA1 \|title=Quality Management Systems: A Practical Guide \|author=Gitlow, H.S. \|publisher=CRC Press \|pages=296 \|year=2000 \|isbn=9781574442618}}</ref> This led to several Japanese scientists and engineers inviting Deming to Japan in 1950 to share his ideas on statistical methods towards improved quality, with several companies seeing productivity and profit gains after adoption.<ref name="GitlowQuality00" /> In 1951, engineer and management consultant Joseph M. Juran published the first edition of ''Juran's Quality Handbook'', an influential guide to quality management that focused on "fitness for use by the customer" as a goal of quality. Juran's work, focusing on management's influence on quality, had a similar impact on the Japanese. The combination of Deming's and Juran's influence ultimately led to the Japanese developing their own take on quality management: Japanese Total Quality Control.<ref name="GitlowQuality00" />

	In the mid-twentieth century, the focus on quality as a ~~profession~~ and a managerial process saw the quality profession grow from simple engineering controls to systems engineering that took quality into account at its various steps. This was most noticeable in the Japanese strategy to industry, though the U.S. didn't clearly recognize it until the early 1980s. With the decline in price competition and increase in quality competition in the 1970's putting American manufacturing in a difficult position, the early to mid-1980s saw the U.S.' industrial and government leaders recognize Japan's quality strategy<ref name="ASQTotal">{{cite web \|url=http://asq.org/learn-about-quality/history-of-quality/overview/total-quality.html \|title=Total Quality \|work=Learn About Quality \|publisher=American Society for Quality \|accessdate=27 October 2017}}</ref>, committing to a renewed emphasis on quality in order to stay relevant in an expanding and competitive world market. The [[Malcolm Baldrige National Quality Improvement Act of 1987]] spawned the associated National Quality Program, commonly referred to as the Baldridge model<ref name="Rocha-LonaBuilding13" />, and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the [[ISO 9000\|ISO 9001, 9002, and 9003]] standards were published; based off work from previous British and U.S. military standards, the ~~standard~~ sought to "provide organizations with the requirements to create a quality management system (QMS) for a range of different business activities."<ref name="QMSIntISO16">{{cite web \|url=https://www.qmsuk.com/news/iso-9002-and-9003-is-iso-9001-a-suitable-replacement \|title=ISO 9002 and 9003: Is ISO 9001 a suitable replacement? \|publisher=QMS International \|date=09 December 2017 \|accessdate=02 November 2017}}</ref> Other awards like the Deming Prize were set up by the Japanese, and the first non-Japanese company to win the prize was the U.S.'s Florida Light and Power in 1989.<ref name="ColeManaging99">{{cite book \|url=https://books.google.com/books?id=uBN7CYnaT74C&pg=PA67 \|chapter=Chapter 3: How Much Did You Know and When Did You Know It? \|title=Managing Quality Fads: How American Business Learned to Play the Quality Game \|author=Cole, R.E. \|publisher=Oxford University Press \|pages=63–81 \|year=1999 \|isbn=9780198028604}}</ref> The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.<ref name="Rocha-LonaBuilding13" />		In the mid-twentieth century, the focus on quality as a professional and a managerial process saw the quality profession grow from simple engineering controls to systems engineering that took quality into account at its various steps. This was most noticeable in the Japanese strategy to industry, though the U.S. didn't clearly recognize it until the early 1980s. With the decline in price competition and increase in quality competition in the 1970's putting American manufacturing in a difficult position, the early to mid-1980s saw the U.S.' industrial and government leaders recognize Japan's quality strategy<ref name="ASQTotal">{{cite web \|url=http://asq.org/learn-about-quality/history-of-quality/overview/total-quality.html \|title=Total Quality \|work=Learn About Quality \|publisher=American Society for Quality \|accessdate=27 October 2017}}</ref>, committing to a renewed emphasis on quality in order to stay relevant in an expanding and competitive world market. The [[Malcolm Baldrige National Quality Improvement Act of 1987]] spawned the associated National Quality Program, commonly referred to as the Baldridge model<ref name="Rocha-LonaBuilding13" />, and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the [[ISO 9000\|ISO 9001, 9002, and 9003]] standards were published; based off work from previous British and U.S. military standards, the standards sought to "provide organizations with the requirements to create a quality management system (QMS) for a range of different business activities."<ref name="QMSIntISO16">{{cite web \|url=https://www.qmsuk.com/news/iso-9002-and-9003-is-iso-9001-a-suitable-replacement \|title=ISO 9002 and 9003: Is ISO 9001 a suitable replacement? \|publisher=QMS International \|date=09 December 2017 \|accessdate=02 November 2017}}</ref> Other awards like the Deming Prize were set up by the Japanese, and the first non-Japanese company to win the prize was the U.S.'s Florida Light and Power in 1989.<ref name="ColeManaging99">{{cite book \|url=https://books.google.com/books?id=uBN7CYnaT74C&pg=PA67 \|chapter=Chapter 3: How Much Did You Know and When Did You Know It? \|title=Managing Quality Fads: How American Business Learned to Play the Quality Game \|author=Cole, R.E. \|publisher=Oxford University Press \|pages=63–81 \|year=1999 \|isbn=9780198028604}}</ref> The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.<ref name="Rocha-LonaBuilding13" />

	By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.<ref name="QMSIntISO16" /> At least 150 countries adopted the ISO 9000 standards by the end of 1999, with the associated third-party registration industry having a total economic impact of $4 billion. ~~That~~ number had climbed to 161 ~~countries~~ by the summer of 2002<ref name="SchlickmanISO09001_03b">{{cite book \|url=https://books.google.com/books?id=FkQB4GRB7uwC \|title=ISO 9001:2000 Quality Management System Design \|author=Schlickman, J.J. \|publisher=Artech House \|page=xxii \|year=2003 \|isbn=9781580535960}}</ref>, after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.<ref name="QMSIntISO16" /> Changes in 2008 were minor, but the 2015 revision saw major revisions in structure and how common requirements were aligned with other relevant standards, with more of a focus on risk-based thinking.<ref name="QMSIntISO16" />		By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.<ref name="QMSIntISO16" /> At least 150 countries adopted the ISO 9000 standards by the end of 1999, with the associated third-party registration industry having a total economic impact of $4 billion. The number of adopting countries had climbed to 161 by the summer of 2002<ref name="SchlickmanISO09001_03b">{{cite book \|url=https://books.google.com/books?id=FkQB4GRB7uwC \|title=ISO 9001:2000 Quality Management System Design \|author=Schlickman, J.J. \|publisher=Artech House \|page=xxii \|year=2003 \|isbn=9781580535960}}</ref>, after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.<ref name="QMSIntISO16" /> Changes in 2008 were minor, but the 2015 revision saw major revisions in structure and how common requirements were aligned with other relevant standards, with more of a focus on risk-based thinking.<ref name="QMSIntISO16" />

	==QMS standards and elements==		==QMS standards and elements==