Difference between revisions of "Quality management system"

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[[File:Baldrige Award Crystal with MBNQA backdrop, 2013 Baldrige Award Ceremony, April 6, 2014 (13887406957).jpg|thumb|right|400px|The Malcolm Baldrige National Quality Award is a prestigious National Institute of Standards and Technology-managed award that honors excellence in product and process, customer, workforce, leadership, and financial outcomes that are based on a quality management system.]]A '''quality management system''' ('''QMS''') represents the collection of documented processes, management models, business strategies, human capital, and information technology that are used to plan, develop, deploy, evaluate, and improve a set of models, methods, and tools across an organization for the purpose of improving quality, particularly in-line with the organization's strategic goals. The successful development and deployment of a QMS requires the assessment of organizational resources, customer needs, industry product cycles, and more.<ref name="Rocha-LonaBuilding13">{{cite book |url=https://books.google.com/books?id=i0sriCb7tLYC&pg=PA1 |title=Building Quality Management Systems: Selecting the Right Methods and Tools |author=Rocha-Lona, L.; Garza-Reyes, J.A.; Kumar, V. |publisher=CRC Press |year=2013 |pages=202 |isbn=9781466564992}}</ref> A QMS will attempt to establish organizational policy and objectives for resource management, assign responsibility and authority to personnel, and put into place an organizational structure among personnel.<ref name="SchlickmanISO09001_03a">{{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=14 |year=2003 |isbn=9781580535960}}</ref> The QMS will also be designed to focus on the core elements of quality management: planning, [[Quality control|control]], [[Quality assurance|assurance]], and improvement.<ref name="NandaQuality16">{{cite book |url=https://books.google.com/books?id=guizsuAAyR4C&pg=PA1 |title=Quality Management System Handbook for Product Development Companies |author=Nanda, V. |publisher=CRC Press |pages=352 |year=2016 |isbn=9781420025309}}</ref> However, a QMS should not be confused with product and service standards, which tend to give "explicit requirements that specific products and services should conform to" rather than broad good management practices applicable to any product or service.<ref name="ISOISO9001_16">{{cite web |url=https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_9001_2015_for_small_enterprises-preview.pdf |format=PDF |title=ISO 9001:2015 for Small Enterprises: What to do? |author=ISO/TC 176 |publisher=ISO |date=2016 |isbn=9789267106946}}</ref>
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A '''quality management system''' ('''QMS''') represents the collection of documented processes, management models, business strategies, human capital, and information technology that are used to plan, develop, deploy, and evaluate a set of models, methods, and tools across an organization for the purpose of improving quality, particularly in-line with the organization's strategic goals. The successful development and deployment of a QMS requires the assessment of organizational resources, customer needs, industry product cycles, and more.<ref name="Rocha-LonaBuilding13">{{cite book |url=https://books.google.com/books?id=i0sriCb7tLYC&pg=PA1 |title=Building Quality Management Systems: Selecting the Right Methods and Tools |author=Rocha-Lona, L.; Garza-Reyes, J.A.; Kumar, V. |publisher=CRC Press |year=2013 |pages=202 |isbn=9781466564992}}</ref> A QMS will attempt to establish organizational policy and objectives for resource management, assign responsibility and authority to personnel, and put into place an organizational structure among personnel.<ref name="SchlickmanISO09001_03a">{{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=14 |year=2003 |isbn=9781580535960}}</ref> The QMS will also be designed to focus on the core elements of quality management: planning, control, assurance, and improvement.<ref name="NandaQuality16">{{cite book |url=https://books.google.com/books?id=guizsuAAyR4C&pg=PA1 |title=Quality Management System Handbook for Product Development Companies |author=Nanda, V. |publisher=CRC Press |pages=352 |year=2016 |isbn=9781420025309}}</ref>


A successful quality management system may drive competitiveness in the organization, but competitiveness is not the core goal of a QMS; rather, customer satisfaction and, to a lesser degree, financial performance are tied to a successful QMS implementation.<ref name="Rocha-LonaBuilding13" />
A successful quality management system may drive competitiveness in the organization, but competitiveness is not the core goal of a QMS; rather, customer satisfaction and, to a lesser degree, financial performance are tied to a successful QMS implementation.<ref name="Rocha-LonaBuilding13" /> Additionally, a QMS may reduce waste, identify and facilitate training, and improve staff engagement.<ref name="ASQWhatIs">{{cite web |urlhttps://asq.org/quality-resources/quality-management-system |title=What Is A Quality Management System (QMS)? ISO 9001 & Other Quality Management Systems |publisher=American Society for Quality |accessdate=07 January 2022}}</ref>


==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 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 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=https://asq.org/quality-resources/history-of-quality#development |title=Total Quality |work=Learn About Quality |publisher=American Society for Quality |accessdate=07 January 2022}}</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 standard 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" />


==Elements==
==QMS standards and elements==
# [[Quality policy]]
Many standards are used internationally for designing, implementing, and auditing quality management systems, though ISO 9001:2015 is the most well recognized and used. Other standards include<ref name="ASQWhatIs" />:
# [[Quality objectives]]
# Quality manual
# [[Organizational structure]] and responsibilities
# [[Data Management|Data management]]
# Processes – including purchasing
# Product quality leading to [[customer satisfaction]]
# [[Continuous improvement]] including [[corrective and preventive action]]
#  Quality instruments
# [http://www.qi-a.com/Quality-Management-Systems-Software/Document-Control.aspx Document control]


* [[ISO 9000]] and 9004
* [[ISO 13485]] for medical devices
* [[ISO 14000|ISO 14001]] for environmental management
* [[ISO 15189]] for medical laboratories
* ISO 19011 for auditing management
* ISO/IEC 17021-1 for bodies auditing and certifying management systems
* [[ISO/IEC 17025]] for laboratories (to be updated at the end of 2017<ref name="TranchardISOIEC17">{{cite web |url=https://www.iso.org/news/ref2212.html |title=ISO/IEC 17025 moves to final stage of revision |author=Tranchard, S. |work=ISO News |publisher=International Organization for Standardization |date=06 September 2017 |accessdate=09 November 2017}}</ref>)
* [[ISO/TS 16949]] for automotive manufacturing


===Process===
===QMS elements===
A QMS process is an element of an organizational QMS. The [[ISO 9000|ISO9001:2000]] standard requires organizations seeking [[compliance (regulation)|compliance]] or [[certification]] to define the processes which form the QMS and the sequence and interaction of these processes. [[Butterworth-Heinemann]] and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.
While quality management systems may vary by industry and by company policy, most typically share the same base-level elements, including<ref name="ASQWhatIs" />:


Examples of such processes include:
* organizational quality policy and objectives
* quality manual
* set of procedures, instructions, and records
* [[Information management|data management]]
* internal processes
* product/service quality that leads to customer satisfaction
* quality analysis
* [[Continual improvement process|continual improvement]], including corrective and preventive action


* order processes,
====Quality policy and objectives====
* [[production plans]],
These items should be an expression of senior management's desire to commit to a QMS, based on the standard(s) used and the company's vision and mission. The policy will largely focus on customers and other interested parties, using a process approach that uses evidence-based decision making and encourages improvement. Quality objectives are derived from the policy and cover all functional levels of the business.<ref name="ISO9000PlainEngDefs">{{cite web |url=https://www.praxiom.com/iso-definition.htm |title=ISO 9000 2015 Plain English Definitions |work=ISO Standards (In Plain English) |publisher=Praxiom Research Group Limited |date=04 February 2017 |accessdate=07 January 2022}}</ref>
* [[product (business)|product]]/ [[service (economics)|service]]/ [[process modeling|process]] measurements to comply with specific requirements e.g. [[statistical process control]] and [[measurement systems analysis]],
* [[calibrations]],
* [[internal audits]],
* [[corrective actions]],
* [[preventive actions]],
* identification, labeling and control of [[conformance testing|non-conforming]] [[product (business)|products]] to prevent its inadvertent use, delivery or processing,
* [[purchasing]] and related processes such as [[distributor (business)|supplier]] selection and [[wikt:monitoring|monitoring]]


ISO9001 requires that the performance of these processes be measured, analyzed and [[continuous improvement|continually improved]], and the results of this form an input into the [[management]] review process.
====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 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=https://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=07 January 2022}}</ref>


==Medical devices==
====Procedures, instructions, and records====
The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the [[ISO 13485]] standards and the US FDA [[21 CFR 820]] regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.
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>


ISO 13485 are harmonized with the European Union [[medical devices directive]] (93/42/EEC) as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).
====Data management====
From creating the policies and procedures to tracking conformance to them, files records of various sorts are inevitably created. Being able to integrate those documents and related data across the enterprise can be tricky but beneficial. Strong data management policies applied to quality data help businesses can not only mitigate risk and determine trends but also help them maintain regulatory compliance. Setting up data management policies and systems requires planning, however, including determining data types, data ownership, data quality, and metadata availability. Additional, any quality data management policy and system should meet organizational goals while identifying what should be included and excluded, and they should include a clear roadmap for how it will be implemented. Quality data management systems should be able to hand normalization, versioning, archiving, and compliance-related security.<ref name="LewisDataQ15">{{cite web |url=https://www.scienteconsulting.com/blogs/785/data-quality-management-big-data-analytics/ |title=Data Quality Management for Better Big Data Analytics |author=Lewis, M. |publisher=Sciente Consulting Pte. Ltd |date=10 August 2015 |accessdate=07 January 2022}}</ref>


Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a  [http://www.gmp1st.com/md96p.pdf final rule published on October 7, 1996]. The [[U.S. Food and Drug Administration]] (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at [http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html 21 CFR 820].
====Internal processes====
[[File:UserSatisfaction.jpg|right|thumb|500px|Guaging product and service quality through customer satisfaction analysis is another major part of a quality management system.]]
Keeping a QMS process-based allows the various inputs and outputs of a business stay connected and unified in quality. By recognizing that "the output of one process becomes the input of another process,"<ref name="ISO9000PlainEngDefs" /> a single integrated process that depends on quality is revealed. Derived from procedures and instructions, a process map is built, detailing resources, authority, risks, and evaluation methods that are associated with those processes.<ref name="PraxiomISO9001_17">{{cite web |url=https://www.praxiom.com/iso-9001.htm |title=ISO 9001 Translated Into Plain English |publisher=Praxiom Research Group Limited |date=16 August 2017 |accessdate=07 January 2022}}</ref>


According to current [[Good Manufacturing Practice]] (GMP), [[medical device]] manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in [http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html Part 820] of the QS regulation. 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.
====Focus on customers====
Product and/or service quality that leads to customer satisfaction is a primary goal of a QMS. This focus often comes down from senior leadership, who encourages personnel to take a similar focus through the management of relevant requirements, the management of relevant risks and opportunities, and the commitment to improving customer satisfaction.<ref name="PraxiomISO9001_17" /> Overall company policies should include this focus, which should then make it's way into more effective process management, and by extension, higher customer satisfaction, measured using a set of principles that include data collected directly from customers and an additive formula that aggregates all that data into a global picture of satisfaction.<ref name="SiskosMeasuring02">{{cite book |chapter=Measuring Customer Satisfaction for Various Services Using Multicriteria Analysis |title=Aiding Decisions with Multiple Criteria |series=International Series in Operations Research & Management Science |volume=44 |author=Siskos, Y.; Grigoroudis, E. |editor=Bouyssou, D.; Jacquet-Lagrèze, E.; Perny, P. et al. |publisher=Springer Boston |year=2002 |doi=10.1007/978-1-4615-0843-4_20 |isbn=9781461508434}}</ref>


The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. These subsystems include:
====Quality analysis====
[[Image:Qualsystem1.png|thumb|Quality system]]
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.  
* Management controls;
* [[Design controls]];
* Production and process controls
* Corrective and preventative actions
* Material controls
* Records, documents, and change controls
* Facilities and equipment controls
all overseen by management and quality audits.


Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left 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 there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.
====Continual improvement====
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" />


Drug manufactures are regulated under a different section of the [[Code of Federal Regulations]]:
==Special cases==
===Laboratories===
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 |archiveurl=https://web.archive.org/web/20171109230926/ttps://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 |archivedate=09 November 2017 |accessdate=07 January 2022}}</ref>


==Organizations and awards==
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=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 |accessdate=21 November 2017}}</ref>
{{See also|List of national quality awards}}
The  [[International Organization for Standardization]]'s [[ISO 9001|ISO 9001:2015]] series describes standards for a QMS addressing the principles and processes surrounding the [[design]], [[new product development|development,]] and delivery of a general [[Product (business)|product]] or [[Service (economics)|service]]. Organizations can participate in a continuing certification process to ISO 9001:2008 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 (FMEA).<ref>{{cite journal |doi=10.1108/09544780210439734 |title=The state of ISO 9000 certification: A study of Swedish organizations |year=2002 |last1=Poksinska |first1=Bozena |last2=Dahlgaard |first2=Jens Jörn |last3=Antoni |first3=Marc |journal=The TQM Magazine |volume=14 |issue=5 |pages=297}}</ref>


(ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on quality management approach for the sustained success of an [http://www.qi-a.com/Quality-Management-Software-QHSE-Whitepaper/How-To-Use-Iso-9001-To-Run-Your-Organization-.aspx organization].  Neither of these standards can be used for certification purposes as they provide guidance, not requirements).
===Medical device industry===
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 |archiveurl=https://web.archive.org/web/20170925072043/https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en |title=Medical Devices: Regulatory Framework |publisher=European Commission |date=11 September 2017 |archivedate=25 September 2017 |accessdate=07 January 2022}}</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 [https://www.nist.gov/baldrige/ 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 [https://www.nist.gov/baldrige/publications/criteria.cfm 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.
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.


The [[European Foundation for Quality Management]]'s [[EFQM Excellence Model]] supports an award scheme similar to the Baldrige Award for European companies.
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.


In Canada, the [http://www.nqi.ca National Quality Institute] presents the '[https://web.archive.org/web/20060206134247/http://www.nqi.ca/CAEAwards/default.aspx 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.
==Electronic quality management system==
As businesses and organizations have begun converting to digital data management methodologies and bringing data sources together for improved workflow and insights, the quality management system has moved from the paper realm to the electronic realm. This change allows for a more dynamic QMS that can be analyzed and updated more readily while digitally serving up a quality message to everyone in the organization.<ref name="ArbogastElectronic09">{{cite web |url=https://www.qualitydigest.com/inside/quality-insider-article/electronic-quality-management-systems-are-worth-money.html |title=Electronic Quality Management Systems Are Worth The Money |work=Quality Digest |author=Arbogast, S. |publisher=Quality Circle Institute, Inc |date=07 July 2009 |accessdate=21 November 2017}}</ref> An electronic QMS (eQMS) also provides more real-time data management, including automatically keeping track of any trend-related metrics that management require, record retention policies, inspection data, training records, and risk analysis data.<ref name="RamchandaniEbracing14">{{cite web |url=https://www.pharmout.net/embracing-an-electronic-qms/ |title=Embracing an electronic quality management system |author=Ramchandani, H. |work=PharmOut |publisher=PharmOut Pty Ltd |date=07 October 2014 |accessdate=21 November 2017}}</ref><ref name="JensenHowAn17">{{cite web |url=http://mastercontrolinc.blogspot.com/2017/05/how-electronic-quality-management.html |archiveurl=https://web.archive.org/web/20170713180729/http://mastercontrolinc.blogspot.com/2017/05/how-electronic-quality-management.html |title=How an Electronic Quality Management System Helps With Cybersecurity |author=Jensen, D. |work=MasterControl Blog |publisher=MasterControl, Inc |date=25 May 2017 |archivedate=13 July 2017 |accessdate=07 January 2022}}</ref>


The European Quality in Social Service [[European Quality in Social Services|(EQUASS]]) is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to [[Social exclusion|vulnerable groups]], such as empowerment, rights, and [[Person-centred planning|person-centredness]]. [http://www.equass.be ]
The eQMS may also integrate features from other software systems, including<ref name="OlamijiImplement16">{{cite book |url=https://researchportal.port.ac.uk/portal/files/5489195/Thesis_QMS_2016.pdf |title=Implementation of an electronic quality management system document management module to support reconfiguration of a district general hospital pathology department quality management system |chapter=3.3 Electronic document management software (EDMS) (Literature review) |author=Olamiji, O. |publisher=University of Portsmouth |date=February 2016 |accessdate=28 November 2017}}</ref><ref name="WalshWhy15">{{cite web |url=http://www.qumas.com/why-does-your-organization-need-electronic-quality-management-system |archiveurl=https://web.archive.org/web/20170825090231/http://www.qumas.com/why-does-your-organization-need-electronic-quality-management-system |title=Why does your organization need an electronic quality management system? |author=Walsh, C. |publisher=QUMAS Limited |date=29 January 2015 |archivedate=25 August 2017 |accessdate=07 January 2022}}</ref>:


The [http://www.baldrigepe.org/alliance/ Alliance for Performance Excellence] is a network of state and local organizations that use the [https://www.nist.gov/baldrige/publications/criteria.cfm Baldrige Criteria for Performance Excellence] at the grassroots level to improve the performance of local organizations and economies. browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.
* document management, including change control and automated forms/reports
* assignment and scheduling
* [[corrective and preventive action]] (CAPA)
* learning management
* audit trail and tracking
* customer management
* process and workflow management
* electronic submission management


==Certifications and awards==
[[File:Quality model (inverted).jpg|right|thumb|A visualization of the European Foundation for Quality Management's take on total quality management]]
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>
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>
In Europe, the European Foundation for Quality Management's EFQM Model supports an award scheme similar to the Baldrige Award for European companies.<ref name="EFQMModel">{{cite web |url=https://www.efqm.org/efqm-model/ |title=The EFQM Model |publisher=EFQM |accessdate=07 January 2022}}</ref> Additionally, the European Quality in Social Services (EQUASS) sector-specific quality system addresses quality principles that are specific to personal services providers in the social and vocational education and training (VET) sectors.<ref name="QUASSAbout">{{cite web |url=https://www.equass.be/index.php/about-equass |title=About EQUASS |publisher=European Platform for Rehabilitation |accessdate=21 November 2017}}</ref>
==Further reading==
* {{cite web |url=https://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf |archiveurl=https://web.archive.org/web/20171109230926/ttps://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 |pages=175 |date=2016 |archivedate=09 November 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}}
==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].
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[[Category:Quality management]]
[[Category:Software systems]]
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Latest revision as of 17:21, 18 September 2022

The Malcolm Baldrige National Quality Award is a prestigious National Institute of Standards and Technology-managed award that honors excellence in product and process, customer, workforce, leadership, and financial outcomes that are based on a quality management system.

A quality management system (QMS) represents the collection of documented processes, management models, business strategies, human capital, and information technology that are used to plan, develop, deploy, evaluate, and improve a set of models, methods, and tools across an organization for the purpose of improving quality, particularly in-line with the organization's strategic goals. The successful development and deployment of a QMS requires the assessment of organizational resources, customer needs, industry product cycles, and more.[1] A QMS will attempt to establish organizational policy and objectives for resource management, assign responsibility and authority to personnel, and put into place an organizational structure among personnel.[2] The QMS will also be designed to focus on the core elements of quality management: planning, control, assurance, and improvement.[3] However, a QMS should not be confused with product and service standards, which tend to give "explicit requirements that specific products and services should conform to" rather than broad good management practices applicable to any product or service.[4]

A successful quality management system may drive competitiveness in the organization, but competitiveness is not the core goal of a QMS; rather, customer satisfaction and, to a lesser degree, financial performance are tied to a successful QMS implementation.[1] Additionally, a QMS may reduce waste, identify and facilitate training, and improve staff engagement.[5]

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 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."[6]

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.[7] 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."[8]

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.[9] 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.[9] 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.[9]

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[10], 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[1], and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the 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."[11] 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.[12] The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.[1]

By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.[11] 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[13], after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.[11] 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.[11]

QMS standards and elements

Many standards are used internationally for designing, implementing, and auditing quality management systems, though ISO 9001:2015 is the most well recognized and used. Other standards include[5]:

  • ISO 9000 and 9004
  • ISO 13485 for medical devices
  • ISO 14001 for environmental management
  • ISO 15189 for medical laboratories
  • ISO 19011 for auditing management
  • ISO/IEC 17021-1 for bodies auditing and certifying management systems
  • ISO/IEC 17025 for laboratories (to be updated at the end of 2017[14])
  • ISO/TS 16949 for automotive manufacturing

QMS elements

While quality management systems may vary by industry and by company policy, most typically share the same base-level elements, including[5]:

  • organizational quality policy and objectives
  • quality manual
  • set of procedures, instructions, and records
  • data management
  • internal processes
  • product/service quality that leads to customer satisfaction
  • quality analysis
  • continual improvement, including corrective and preventive action

Quality policy and objectives

These items should be an expression of senior management's desire to commit to a QMS, based on the standard(s) used and the company's vision and mission. The policy will largely focus on customers and other interested parties, using a process approach that uses evidence-based decision making and encourages improvement. Quality objectives are derived from the policy and cover all functional levels of the business.[15]

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 continual improvement.[16][17]

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."[18] 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.[19]

Data management

From creating the policies and procedures to tracking conformance to them, files records of various sorts are inevitably created. Being able to integrate those documents and related data across the enterprise can be tricky but beneficial. Strong data management policies applied to quality data help businesses can not only mitigate risk and determine trends but also help them maintain regulatory compliance. Setting up data management policies and systems requires planning, however, including determining data types, data ownership, data quality, and metadata availability. Additional, any quality data management policy and system should meet organizational goals while identifying what should be included and excluded, and they should include a clear roadmap for how it will be implemented. Quality data management systems should be able to hand normalization, versioning, archiving, and compliance-related security.[20]

Internal processes

Guaging product and service quality through customer satisfaction analysis is another major part of a quality management system.

Keeping a QMS process-based allows the various inputs and outputs of a business stay connected and unified in quality. By recognizing that "the output of one process becomes the input of another process,"[15] a single integrated process that depends on quality is revealed. Derived from procedures and instructions, a process map is built, detailing resources, authority, risks, and evaluation methods that are associated with those processes.[21]

Focus on customers

Product and/or service quality that leads to customer satisfaction is a primary goal of a QMS. This focus often comes down from senior leadership, who encourages personnel to take a similar focus through the management of relevant requirements, the management of relevant risks and opportunities, and the commitment to improving customer satisfaction.[21] Overall company policies should include this focus, which should then make it's way into more effective process management, and by extension, higher customer satisfaction, measured using a set of principles that include data collected directly from customers and an additive formula that aggregates all that data into a global picture of satisfaction.[22]

Quality analysis

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.

Continual improvement

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."[23] 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.[23]

Special cases

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.[14] The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories[24]), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.[14] 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.[25]

Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and continual improvement.[26] 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.[27]

Medical device industry

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[28]) 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[28]). 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.

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.

Electronic quality management system

As businesses and organizations have begun converting to digital data management methodologies and bringing data sources together for improved workflow and insights, the quality management system has moved from the paper realm to the electronic realm. This change allows for a more dynamic QMS that can be analyzed and updated more readily while digitally serving up a quality message to everyone in the organization.[29] An electronic QMS (eQMS) also provides more real-time data management, including automatically keeping track of any trend-related metrics that management require, record retention policies, inspection data, training records, and risk analysis data.[30][31]

The eQMS may also integrate features from other software systems, including[32][33]:

  • document management, including change control and automated forms/reports
  • assignment and scheduling
  • corrective and preventive action (CAPA)
  • learning management
  • audit trail and tracking
  • customer management
  • process and workflow management
  • electronic submission management

Certifications and awards

A visualization of the European Foundation for Quality Management's take on total quality management

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.[34]

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.[35] Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.[36]

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.[37]

In Europe, the European Foundation for Quality Management's EFQM Model supports an award scheme similar to the Baldrige Award for European companies.[38] Additionally, the European Quality in Social Services (EQUASS) sector-specific quality system addresses quality principles that are specific to personal services providers in the social and vocational education and training (VET) sectors.[39]

Further reading

Notes

This article reuses a few elements from the Wikipedia article.

References

  1. ↑ 1.0 1.1 1.2 1.3 Rocha-Lona, L.; Garza-Reyes, J.A.; Kumar, V. (2013). Building Quality Management Systems: Selecting the Right Methods and Tools. CRC Press. pp. 202. ISBN 9781466564992. https://books.google.com/books?id=i0sriCb7tLYC&pg=PA1. 
  2. ↑ Schlickman, J.J. (2003). ISO 9001:2000 Quality Management System Design. Artech House. p. 14. ISBN 9781580535960. https://books.google.com/books?id=FkQB4GRB7uwC. 
  3. ↑ Nanda, V. (2016). Quality Management System Handbook for Product Development Companies. CRC Press. pp. 352. ISBN 9781420025309. https://books.google.com/books?id=guizsuAAyR4C&pg=PA1. 
  4. ↑ ISO/TC 176 (2016). "ISO 9001:2015 for Small Enterprises: What to do?" (PDF). ISO. ISBN 9789267106946. https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_9001_2015_for_small_enterprises-preview.pdf. 
  5. ↑ 5.0 5.1 5.2 "What Is A Quality Management System (QMS)? ISO 9001 & Other Quality Management Systems". American Society for Quality. 
  6. ↑ Hendrickson, K.E. (2014). "Quality Assurance and Control". The Encyclopedia of the Industrial Revolution in World History. 3. Rowman & Littlefield. ISBN 9780810888883. https://books.google.com/books?id=EdwsCgAAQBAJ&pg=PA758. 
  7. ↑ Papp, J. (2014). Quality Management in the Imaging Sciences. Elsevier Health Sciences. pp. 372. ISBN 9780323261999. https://books.google.com/books?id=1akTBQAAQBAJ&pg=PA3. 
  8. ↑ Wood, J.C.; Wood, M.C., ed. (2003). Henry Ford: Critical Evaluations in Business and Management. 1. Taylor and Francis. pp. 384. ISBN 9780415248259. https://books.google.com/books?id=3XXxhbDU9P4C&pg=PA300. 
  9. ↑ 9.0 9.1 9.2 Gitlow, H.S. (2000). Quality Management Systems: A Practical Guide. CRC Press. pp. 296. ISBN 9781574442618. https://books.google.com/books?id=O5aq0HMyXOcC&pg=PA1. 
  10. ↑ "Total Quality". Learn About Quality. American Society for Quality. https://asq.org/quality-resources/history-of-quality#development. Retrieved 07 January 2022. 
  11. ↑ 11.0 11.1 11.2 11.3 "ISO 9002 and 9003: Is ISO 9001 a suitable replacement?". QMS International. 9 December 2017. https://www.qmsuk.com/news/iso-9002-and-9003-is-iso-9001-a-suitable-replacement. Retrieved 02 November 2017. 
  12. ↑ Cole, R.E. (1999). "Chapter 3: How Much Did You Know and When Did You Know It?". Managing Quality Fads: How American Business Learned to Play the Quality Game. Oxford University Press. pp. 63–81. ISBN 9780198028604. https://books.google.com/books?id=uBN7CYnaT74C&pg=PA67. 
  13. ↑ Schlickman, J.J. (2003). ISO 9001:2000 Quality Management System Design. Artech House. p. xxii. ISBN 9781580535960. https://books.google.com/books?id=FkQB4GRB7uwC. 
  14. ↑ 14.0 14.1 14.2 Tranchard, S. (6 September 2017). "ISO/IEC 17025 moves to final stage of revision". ISO News. International Organization for Standardization. https://www.iso.org/news/ref2212.html. Retrieved 09 November 2017. 
  15. ↑ 15.0 15.1 "ISO 9000 2015 Plain English Definitions". ISO Standards (In Plain English). Praxiom Research Group Limited. 4 February 2017. https://www.praxiom.com/iso-definition.htm. Retrieved 07 January 2022. 
  16. ↑ Payne, G.C.. "ISO 9001 Quality Manual". American Society for Quality. https://asq.org/quality-resources/iso-9001-quality-manual. Retrieved 09 November 2017. 
  17. ↑ "What is an ISO 9001 Quality Manual?". 9000 Store. Standards Stores. https://the9000store.com/articles/iso-9000-tips-what-is-a-quality-manual/. Retrieved 07 January 2022. 
  18. ↑ Meskovska, A. (23 October 2014). "How to structure quality management system documentation". ISO 9001 Knowledge Base. Advisera Expert Solutions Ltd. https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/. Retrieved 09 November 2017. 
  19. ↑ Besterfield, D.H.; Besterfield–Michna, C.; Bestefield, G.H. et al. (2011). "Chapter 10: Quality Management Systems". Total Quality Management (Revised 3rd ed.). Pearson Education India. pp. 205–238. ISBN 9788131732274. 
  20. ↑ Lewis, M. (10 August 2015). "Data Quality Management for Better Big Data Analytics". Sciente Consulting Pte. Ltd. https://www.scienteconsulting.com/blogs/785/data-quality-management-big-data-analytics/. Retrieved 07 January 2022. 
  21. ↑ 21.0 21.1 "ISO 9001 Translated Into Plain English". Praxiom Research Group Limited. 16 August 2017. https://www.praxiom.com/iso-9001.htm. Retrieved 07 January 2022. 
  22. ↑ Siskos, Y.; Grigoroudis, E. (2002). "Measuring Customer Satisfaction for Various Services Using Multicriteria Analysis". In Bouyssou, D.; Jacquet-Lagrèze, E.; Perny, P. et al.. Aiding Decisions with Multiple Criteria. International Series in Operations Research & Management Science. 44. Springer Boston. doi:10.1007/978-1-4615-0843-4_20. ISBN 9781461508434. 
  23. ↑ 23.0 23.1 Fatima Chiaradia Valadão, A. de; Silva Campos, P.H. da; Turrioni, J.B. (2013). "Relationship between the Maturity of Continuous Improvement and the Certification of Quality Management System in Automotive Sector in Brazil". Independent Journal of Management & Production 4 (1): 96–110. doi:10.14807/ijmp.v4i1.61. 
  24. ↑ Robins, M.M.; Scarll, S.J.; Key, P.E. (2006). "Quality assurance in research laboratories". Accreditation and Quality Assurance 11 (5): 214–223. doi:10.1007/s00769-006-0129-5. 
  25. ↑ Peters, R.H. (2016). "Developing and Maintaining a Laboratory Quality Management System - Version 3.0" (PDF). American Industrial Hygiene Association. pp. 175. Archived from the original on 09 November 2017. https://web.archive.org/web/20171109230926/ttps://www.aiha.org/education/MyCourses/Lab%20course/2.%20Student%20Manual.pdf. Retrieved 07 January 2022. 
  26. ↑ Flynn, G.J.; Coffey, J. (2011). "ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System". In Michel, R.L.; Khanna, P.. Dark Intelligence Group, Inc. Archived from the original on 09 November 2017. 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. Retrieved 09 November 2017. 
  27. ↑ World Health Organization (2011) (PDF). Laboratory Quality Management System Handbook. World Health Organization. pp. 246. ISBN 9789241548274. https://www.who.int/ihr/publications/lqms_en.pdf. Retrieved 21 November 2017. 
  28. ↑ 28.0 28.1 "Medical Devices: Regulatory Framework". European Commission. 11 September 2017. Archived from the original on 25 September 2017. https://web.archive.org/web/20170925072043/https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en. Retrieved 07 January 2022. 
  29. ↑ Arbogast, S. (7 July 2009). "Electronic Quality Management Systems Are Worth The Money". Quality Digest. Quality Circle Institute, Inc. https://www.qualitydigest.com/inside/quality-insider-article/electronic-quality-management-systems-are-worth-money.html. Retrieved 21 November 2017. 
  30. ↑ Ramchandani, H. (7 October 2014). "Embracing an electronic quality management system". PharmOut. PharmOut Pty Ltd. https://www.pharmout.net/embracing-an-electronic-qms/. Retrieved 21 November 2017. 
  31. ↑ Jensen, D. (25 May 2017). "How an Electronic Quality Management System Helps With Cybersecurity". MasterControl Blog. MasterControl, Inc. Archived from the original on 13 July 2017. https://web.archive.org/web/20170713180729/http://mastercontrolinc.blogspot.com/2017/05/how-electronic-quality-management.html. Retrieved 07 January 2022. 
  32. ↑ Olamiji, O. (February 2016). "3.3 Electronic document management software (EDMS) (Literature review)". Implementation of an electronic quality management system document management module to support reconfiguration of a district general hospital pathology department quality management system. University of Portsmouth. https://researchportal.port.ac.uk/portal/files/5489195/Thesis_QMS_2016.pdf. Retrieved 28 November 2017. 
  33. ↑ Walsh, C. (29 January 2015). "Why does your organization need an electronic quality management system?". QUMAS Limited. Archived from the original on 25 August 2017. https://web.archive.org/web/20170825090231/http://www.qumas.com/why-does-your-organization-need-electronic-quality-management-system. Retrieved 07 January 2022. 
  34. ↑ Lazarte, M. (23 September 2015). "SO 9001:2015 - Just published!". ISO News. International Organization for Standardization. https://www.iso.org/news/2015/09/Ref2002.html. Retrieved 21 November 2017. 
  35. ↑ "How Baldridge Works". Baldrige Performance Excellence Program. National Institute of Standards and Technology. 20 July 2016. https://www.nist.gov/baldrige/how-baldrige-works. Retrieved 21 November 2017. 
  36. ↑ "The Alliance for Performance Excellence". Baldrige Foundation. 2020. https://www.baldrigealliance.org/. Retrieved 07 January 2022. 
  37. ↑ "Canada Awards for Excellence". Excellence Canada. 2016. https://excellence.ca/canada-awards-for-excellence/. Retrieved 07 January 2022. 
  38. ↑ "The EFQM Model". EFQM. https://www.efqm.org/efqm-model/. Retrieved 07 January 2022. 
  39. ↑ "About EQUASS". European Platform for Rehabilitation. https://www.equass.be/index.php/about-equass. Retrieved 21 November 2017. 
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