CINXE.COM

<!DOCTYPE html> <html class="client-nojs vector-feature-language-in-header-enabled vector-feature-language-in-main-page-header-disabled vector-feature-sticky-header-disabled vector-feature-page-tools-pinned-disabled vector-feature-toc-pinned-clientpref-1 vector-feature-main-menu-pinned-disabled vector-feature-limited-width-clientpref-1 vector-feature-limited-width-content-enabled vector-feature-custom-font-size-clientpref-1 vector-feature-appearance-pinned-clientpref-1 vector-feature-night-mode-enabled skin-theme-clientpref-day vector-toc-available" lang="en" dir="ltr"> <head> <meta charset="UTF-8"> <title>Quality management system - Wikipedia</title> <script>(function(){var className="client-js vector-feature-language-in-header-enabled vector-feature-language-in-main-page-header-disabled vector-feature-sticky-header-disabled vector-feature-page-tools-pinned-disabled vector-feature-toc-pinned-clientpref-1 vector-feature-main-menu-pinned-disabled vector-feature-limited-width-clientpref-1 vector-feature-limited-width-content-enabled vector-feature-custom-font-size-clientpref-1 vector-feature-appearance-pinned-clientpref-1 vector-feature-night-mode-enabled skin-theme-clientpref-day vector-toc-available";var cookie=document.cookie.match(/(?:^|; )enwikimwclientpreferences=([^;]+)/);if(cookie){cookie[1].split('%2C').forEach(function(pref){className=className.replace(new RegExp('(^| )'+pref.replace(/-clientpref-\w+$|[^\w-]+/g,'')+'-clientpref-\\w+( |$)'),'$1'+pref+'$2');});}document.documentElement.className=className;}());RLCONF={"wgBreakFrames":false,"wgSeparatorTransformTable":["",""],"wgDigitTransformTable":["",""],"wgDefaultDateFormat":"dmy", "wgMonthNames":["","January","February","March","April","May","June","July","August","September","October","November","December"],"wgRequestId":"2e69f8fe-2326-4fa8-b7a6-2753ffb79cc7","wgCanonicalNamespace":"","wgCanonicalSpecialPageName":false,"wgNamespaceNumber":0,"wgPageName":"Quality_management_system","wgTitle":"Quality management system","wgCurRevisionId":1252955422,"wgRevisionId":1252955422,"wgArticleId":25345,"wgIsArticle":true,"wgIsRedirect":false,"wgAction":"view","wgUserName":null,"wgUserGroups":["*"],"wgCategories":["Articles with short description","Short description is different from Wikidata","Articles lacking in-text citations from September 2010","All articles lacking in-text citations","Articles needing additional references from October 2020","All articles needing additional references","Articles with multiple maintenance issues","Quality management","Engineering management"],"wgPageViewLanguage":"en","wgPageContentLanguage":"en","wgPageContentModel":"wikitext", "wgRelevantPageName":"Quality_management_system","wgRelevantArticleId":25345,"wgIsProbablyEditable":true,"wgRelevantPageIsProbablyEditable":true,"wgRestrictionEdit":[],"wgRestrictionMove":[],"wgNoticeProject":"wikipedia","wgCiteReferencePreviewsActive":false,"wgFlaggedRevsParams":{"tags":{"status":{"levels":1}}},"wgMediaViewerOnClick":true,"wgMediaViewerEnabledByDefault":true,"wgPopupsFlags":0,"wgVisualEditor":{"pageLanguageCode":"en","pageLanguageDir":"ltr","pageVariantFallbacks":"en"},"wgMFDisplayWikibaseDescriptions":{"search":true,"watchlist":true,"tagline":false,"nearby":true},"wgWMESchemaEditAttemptStepOversample":false,"wgWMEPageLength":20000,"wgRelatedArticlesCompat":[],"wgCentralAuthMobileDomain":false,"wgEditSubmitButtonLabelPublish":true,"wgULSPosition":"interlanguage","wgULSisCompactLinksEnabled":false,"wgVector2022LanguageInHeader":true,"wgULSisLanguageSelectorEmpty":false,"wgWikibaseItemId":"Q608513","wgCheckUserClientHintsHeadersJsApi":["brands","architecture","bitness", "fullVersionList","mobile","model","platform","platformVersion"],"GEHomepageSuggestedEditsEnableTopics":true,"wgGETopicsMatchModeEnabled":false,"wgGEStructuredTaskRejectionReasonTextInputEnabled":false,"wgGELevelingUpEnabledForUser":false};RLSTATE={"ext.globalCssJs.user.styles":"ready","site.styles":"ready","user.styles":"ready","ext.globalCssJs.user":"ready","user":"ready","user.options":"loading","ext.cite.styles":"ready","skins.vector.search.codex.styles":"ready","skins.vector.styles":"ready","skins.vector.icons":"ready","jquery.makeCollapsible.styles":"ready","ext.wikimediamessages.styles":"ready","ext.visualEditor.desktopArticleTarget.noscript":"ready","ext.uls.interlanguage":"ready","wikibase.client.init":"ready","ext.wikimediaBadges":"ready"};RLPAGEMODULES=["ext.cite.ux-enhancements","mediawiki.page.media","site","mediawiki.page.ready","jquery.makeCollapsible","mediawiki.toc","skins.vector.js","ext.centralNotice.geoIP","ext.centralNotice.startUp","ext.gadget.ReferenceTooltips", "ext.gadget.switcher","ext.urlShortener.toolbar","ext.centralauth.centralautologin","mmv.bootstrap","ext.popups","ext.visualEditor.desktopArticleTarget.init","ext.visualEditor.targetLoader","ext.echo.centralauth","ext.eventLogging","ext.wikimediaEvents","ext.navigationTiming","ext.uls.interface","ext.cx.eventlogging.campaigns","ext.cx.uls.quick.actions","wikibase.client.vector-2022","ext.checkUser.clientHints","ext.growthExperiments.SuggestedEditSession","wikibase.sidebar.tracking"];</script> <script>(RLQ=window.RLQ||[]).push(function(){mw.loader.impl(function(){return["user.options@12s5i",function($,jQuery,require,module){mw.user.tokens.set({"patrolToken":"+\\","watchToken":"+\\","csrfToken":"+\\"}); }];});});</script> <link rel="stylesheet" href="/w/load.php?lang=en&modules=ext.cite.styles%7Cext.uls.interlanguage%7Cext.visualEditor.desktopArticleTarget.noscript%7Cext.wikimediaBadges%7Cext.wikimediamessages.styles%7Cjquery.makeCollapsible.styles%7Cskins.vector.icons%2Cstyles%7Cskins.vector.search.codex.styles%7Cwikibase.client.init&only=styles&skin=vector-2022"> <script async="" src="/w/load.php?lang=en&modules=startup&only=scripts&raw=1&skin=vector-2022"></script> <meta name="ResourceLoaderDynamicStyles" content=""> <link rel="stylesheet" href="/w/load.php?lang=en&modules=site.styles&only=styles&skin=vector-2022"> <meta name="generator" content="MediaWiki 1.44.0-wmf.4"> <meta name="referrer" content="origin"> <meta name="referrer" content="origin-when-cross-origin"> <meta name="robots" content="max-image-preview:standard"> <meta name="format-detection" content="telephone=no"> <meta name="viewport" content="width=1120"> <meta property="og:title" content="Quality management system - Wikipedia"> <meta property="og:type" content="website"> <link rel="preconnect" href="//upload.wikimedia.org"> <link rel="alternate" media="only screen and (max-width: 640px)" href="//en.m.wikipedia.org/wiki/Quality_management_system"> <link rel="alternate" type="application/x-wiki" title="Edit this page" href="/w/index.php?title=Quality_management_system&action=edit"> <link rel="apple-touch-icon" href="/static/apple-touch/wikipedia.png"> <link rel="icon" href="/static/favicon/wikipedia.ico"> <link rel="search" type="application/opensearchdescription+xml" href="/w/rest.php/v1/search" title="Wikipedia (en)"> <link rel="EditURI" type="application/rsd+xml" href="//en.wikipedia.org/w/api.php?action=rsd"> <link rel="canonical" href="https://en.wikipedia.org/wiki/Quality_management_system"> <link rel="license" href="https://creativecommons.org/licenses/by-sa/4.0/deed.en"> <link rel="alternate" type="application/atom+xml" title="Wikipedia Atom feed" href="/w/index.php?title=Special:RecentChanges&feed=atom"> <link rel="dns-prefetch" href="//meta.wikimedia.org" /> <link rel="dns-prefetch" href="//login.wikimedia.org"> </head> <body class="skin--responsive skin-vector skin-vector-search-vue mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-0 ns-subject mw-editable page-Quality_management_system rootpage-Quality_management_system skin-vector-2022 action-view"><a class="mw-jump-link" href="#bodyContent">Jump to content</a> <div class="vector-header-container"> <header class="vector-header mw-header"> <div class="vector-header-start"> <nav class="vector-main-menu-landmark" aria-label="Site"> <div id="vector-main-menu-dropdown" class="vector-dropdown vector-main-menu-dropdown vector-button-flush-left vector-button-flush-right" > <input type="checkbox" id="vector-main-menu-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-main-menu-dropdown" class="vector-dropdown-checkbox " aria-label="Main menu" > <label id="vector-main-menu-dropdown-label" for="vector-main-menu-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-menu mw-ui-icon-wikimedia-menu"></span> <span class="vector-dropdown-label-text">Main menu</span> </label> <div class="vector-dropdown-content"> <div id="vector-main-menu-unpinned-container" class="vector-unpinned-container"> <div id="vector-main-menu" class="vector-main-menu vector-pinnable-element"> <div class="vector-pinnable-header vector-main-menu-pinnable-header vector-pinnable-header-unpinned" data-feature-name="main-menu-pinned" data-pinnable-element-id="vector-main-menu" data-pinned-container-id="vector-main-menu-pinned-container" data-unpinned-container-id="vector-main-menu-unpinned-container" > <div class="vector-pinnable-header-label">Main menu</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-main-menu.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-main-menu.unpin">hide</button> </div> <div id="p-navigation" class="vector-menu mw-portlet mw-portlet-navigation" > <div class="vector-menu-heading"> Navigation </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="n-mainpage-description" class="mw-list-item"><a href="/wiki/Main_Page" title="Visit the main page [z]" accesskey="z"><span>Main page</span></a></li><li id="n-contents" class="mw-list-item"><a href="/wiki/Wikipedia:Contents" title="Guides to browsing Wikipedia"><span>Contents</span></a></li><li id="n-currentevents" class="mw-list-item"><a href="/wiki/Portal:Current_events" title="Articles related to current events"><span>Current events</span></a></li><li id="n-randompage" class="mw-list-item"><a href="/wiki/Special:Random" title="Visit a randomly selected article [x]" accesskey="x"><span>Random article</span></a></li><li id="n-aboutsite" class="mw-list-item"><a href="/wiki/Wikipedia:About" title="Learn about Wikipedia and how it works"><span>About Wikipedia</span></a></li><li id="n-contactpage" class="mw-list-item"><a href="//en.wikipedia.org/wiki/Wikipedia:Contact_us" title="How to contact Wikipedia"><span>Contact us</span></a></li> </ul> </div> </div> <div id="p-interaction" class="vector-menu mw-portlet mw-portlet-interaction" > <div class="vector-menu-heading"> Contribute </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="n-help" class="mw-list-item"><a href="/wiki/Help:Contents" title="Guidance on how to use and edit Wikipedia"><span>Help</span></a></li><li id="n-introduction" class="mw-list-item"><a href="/wiki/Help:Introduction" title="Learn how to edit Wikipedia"><span>Learn to edit</span></a></li><li id="n-portal" class="mw-list-item"><a href="/wiki/Wikipedia:Community_portal" title="The hub for editors"><span>Community portal</span></a></li><li id="n-recentchanges" class="mw-list-item"><a href="/wiki/Special:RecentChanges" title="A list of recent changes to Wikipedia [r]" accesskey="r"><span>Recent changes</span></a></li><li id="n-upload" class="mw-list-item"><a href="/wiki/Wikipedia:File_upload_wizard" title="Add images or other media for use on Wikipedia"><span>Upload file</span></a></li> </ul> </div> </div> </div> </div> </div> </div> </nav> <a href="/wiki/Main_Page" class="mw-logo"> <img class="mw-logo-icon" src="/static/images/icons/wikipedia.png" alt="" aria-hidden="true" height="50" width="50"> <span class="mw-logo-container skin-invert"> <img class="mw-logo-wordmark" alt="Wikipedia" src="/static/images/mobile/copyright/wikipedia-wordmark-en.svg" style="width: 7.5em; height: 1.125em;"> <img class="mw-logo-tagline" alt="The Free Encyclopedia" src="/static/images/mobile/copyright/wikipedia-tagline-en.svg" width="117" height="13" style="width: 7.3125em; height: 0.8125em;"> </span> </a> </div> <div class="vector-header-end"> <div id="p-search" role="search" class="vector-search-box-vue vector-search-box-collapses vector-search-box-show-thumbnail vector-search-box-auto-expand-width vector-search-box"> <a href="/wiki/Special:Search" class="cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only search-toggle" title="Search Wikipedia [f]" accesskey="f"><span class="vector-icon mw-ui-icon-search mw-ui-icon-wikimedia-search"></span> <span>Search</span> </a> <div class="vector-typeahead-search-container"> <div class="cdx-typeahead-search cdx-typeahead-search--show-thumbnail cdx-typeahead-search--auto-expand-width"> <form action="/w/index.php" id="searchform" class="cdx-search-input cdx-search-input--has-end-button"> <div id="simpleSearch" class="cdx-search-input__input-wrapper" data-search-loc="header-moved"> <div class="cdx-text-input cdx-text-input--has-start-icon"> <input class="cdx-text-input__input" type="search" name="search" placeholder="Search Wikipedia" aria-label="Search Wikipedia" autocapitalize="sentences" title="Search Wikipedia [f]" accesskey="f" id="searchInput" > <span class="cdx-text-input__icon cdx-text-input__start-icon"></span> </div> <input type="hidden" name="title" value="Special:Search"> </div> <button class="cdx-button cdx-search-input__end-button">Search</button> </form> </div> </div> </div> <nav class="vector-user-links vector-user-links-wide" aria-label="Personal tools"> <div class="vector-user-links-main"> <div id="p-vector-user-menu-preferences" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <div id="p-vector-user-menu-userpage" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <nav class="vector-appearance-landmark" aria-label="Appearance"> <div id="vector-appearance-dropdown" class="vector-dropdown " title="Change the appearance of the page's font size, width, and color" > <input type="checkbox" id="vector-appearance-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-appearance-dropdown" class="vector-dropdown-checkbox " aria-label="Appearance" > <label id="vector-appearance-dropdown-label" for="vector-appearance-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-appearance mw-ui-icon-wikimedia-appearance"></span> <span class="vector-dropdown-label-text">Appearance</span> </label> <div class="vector-dropdown-content"> <div id="vector-appearance-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <div id="p-vector-user-menu-notifications" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <div id="p-vector-user-menu-overflow" class="vector-menu mw-portlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-sitesupport-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="https://donate.wikimedia.org/wiki/Special:FundraiserRedirector?utm_source=donate&utm_medium=sidebar&utm_campaign=C13_en.wikipedia.org&uselang=en" class=""><span>Donate</span></a> </li> <li id="pt-createaccount-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="/w/index.php?title=Special:CreateAccount&returnto=Quality+management+system" title="You are encouraged to create an account and log in; however, it is not mandatory" class=""><span>Create account</span></a> </li> <li id="pt-login-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="/w/index.php?title=Special:UserLogin&returnto=Quality+management+system" title="You're encouraged to log in; however, it's not mandatory. [o]" accesskey="o" class=""><span>Log in</span></a> </li> </ul> </div> </div> </div> <div id="vector-user-links-dropdown" class="vector-dropdown vector-user-menu vector-button-flush-right vector-user-menu-logged-out" title="Log in and more options" > <input type="checkbox" id="vector-user-links-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-user-links-dropdown" class="vector-dropdown-checkbox " aria-label="Personal tools" > <label id="vector-user-links-dropdown-label" for="vector-user-links-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-ellipsis mw-ui-icon-wikimedia-ellipsis"></span> <span class="vector-dropdown-label-text">Personal tools</span> </label> <div class="vector-dropdown-content"> <div id="p-personal" class="vector-menu mw-portlet mw-portlet-personal user-links-collapsible-item" title="User menu" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-sitesupport" class="user-links-collapsible-item mw-list-item"><a href="https://donate.wikimedia.org/wiki/Special:FundraiserRedirector?utm_source=donate&utm_medium=sidebar&utm_campaign=C13_en.wikipedia.org&uselang=en"><span>Donate</span></a></li><li id="pt-createaccount" class="user-links-collapsible-item mw-list-item"><a href="/w/index.php?title=Special:CreateAccount&returnto=Quality+management+system" title="You are encouraged to create an account and log in; however, it is not mandatory"><span class="vector-icon mw-ui-icon-userAdd mw-ui-icon-wikimedia-userAdd"></span> <span>Create account</span></a></li><li id="pt-login" class="user-links-collapsible-item mw-list-item"><a href="/w/index.php?title=Special:UserLogin&returnto=Quality+management+system" title="You're encouraged to log in; however, it's not mandatory. [o]" accesskey="o"><span class="vector-icon mw-ui-icon-logIn mw-ui-icon-wikimedia-logIn"></span> <span>Log in</span></a></li> </ul> </div> </div> <div id="p-user-menu-anon-editor" class="vector-menu mw-portlet mw-portlet-user-menu-anon-editor" > <div class="vector-menu-heading"> Pages for logged out editors <a href="/wiki/Help:Introduction" aria-label="Learn more about editing"><span>learn more</span></a> </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-anoncontribs" class="mw-list-item"><a href="/wiki/Special:MyContributions" title="A list of edits made from this IP address [y]" accesskey="y"><span>Contributions</span></a></li><li id="pt-anontalk" class="mw-list-item"><a href="/wiki/Special:MyTalk" title="Discussion about edits from this IP address [n]" accesskey="n"><span>Talk</span></a></li> </ul> </div> </div> </div> </div> </nav> </div> </header> </div> <div class="mw-page-container"> <div class="mw-page-container-inner"> <div class="vector-sitenotice-container"> <div id="siteNotice"></div> </div> <div class="vector-column-start"> <div class="vector-main-menu-container"> <div id="mw-navigation"> <nav id="mw-panel" class="vector-main-menu-landmark" aria-label="Site"> <div id="vector-main-menu-pinned-container" class="vector-pinned-container"> </div> </nav> </div> </div> <div class="vector-sticky-pinned-container"> <nav id="mw-panel-toc" aria-label="Contents" data-event-name="ui.sidebar-toc" class="mw-table-of-contents-container vector-toc-landmark"> <div id="vector-toc-pinned-container" class="vector-pinned-container"> <div id="vector-toc" class="vector-toc vector-pinnable-element"> <div class="vector-pinnable-header vector-toc-pinnable-header vector-pinnable-header-pinned" data-feature-name="toc-pinned" data-pinnable-element-id="vector-toc" > <h2 class="vector-pinnable-header-label">Contents</h2> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-toc.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-toc.unpin">hide</button> </div> <ul class="vector-toc-contents" id="mw-panel-toc-list"> <li id="toc-mw-content-text" class="vector-toc-list-item vector-toc-level-1"> <a href="#" class="vector-toc-link"> <div class="vector-toc-text">(Top)</div> </a> </li> <li id="toc-Elements" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Elements"> <div class="vector-toc-text"> <span class="vector-toc-numb">1</span> <span>Elements</span> </div> </a> <ul id="toc-Elements-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Concept_of_quality_–_historical_background" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Concept_of_quality_–_historical_background"> <div class="vector-toc-text"> <span class="vector-toc-numb">2</span> <span>Concept of quality – historical background</span> </div> </a> <ul id="toc-Concept_of_quality_–_historical_background-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Medical_devices" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Medical_devices"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>Medical devices</span> </div> </a> <ul id="toc-Medical_devices-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Organizations_and_awards" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Organizations_and_awards"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Organizations and awards</span> </div> </a> <ul id="toc-Organizations_and_awards-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Process" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Process"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>Process</span> </div> </a> <ul id="toc-Process-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Software" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Software"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Software</span> </div> </a> <ul id="toc-Software-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>References</span> </div> </a> <button aria-controls="toc-References-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle References subsection</span> </button> <ul id="toc-References-sublist" class="vector-toc-list"> <li id="toc-General_references" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#General_references"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.1</span> <span>General references</span> </div> </a> <ul id="toc-General_references-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div id="vector-page-titlebar-toc" class="vector-dropdown vector-page-titlebar-toc vector-button-flush-left" > <input type="checkbox" id="vector-page-titlebar-toc-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-titlebar-toc" class="vector-dropdown-checkbox " aria-label="Toggle the table of contents" > <label id="vector-page-titlebar-toc-label" for="vector-page-titlebar-toc-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-listBullet mw-ui-icon-wikimedia-listBullet"></span> <span class="vector-dropdown-label-text">Toggle the table of contents</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-titlebar-toc-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <h1 id="firstHeading" class="firstHeading mw-first-heading"><span class="mw-page-title-main">Quality management system</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Go to an article in another language. Available in 23 languages" > <label id="p-lang-btn-label" for="p-lang-btn-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--action-progressive mw-portlet-lang-heading-23" aria-hidden="true" ><span class="vector-icon mw-ui-icon-language-progressive mw-ui-icon-wikimedia-language-progressive"></span> <span class="vector-dropdown-label-text">23 languages</span> </label> <div class="vector-dropdown-content"> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li class="interlanguage-link interwiki-af mw-list-item"><a href="https://af.wikipedia.org/wiki/Kwaliteitsbestuurstelsel" title="Kwaliteitsbestuurstelsel – Afrikaans" lang="af" hreflang="af" data-title="Kwaliteitsbestuurstelsel" data-language-autonym="Afrikaans" data-language-local-name="Afrikaans" class="interlanguage-link-target"><span>Afrikaans</span></a></li><li class="interlanguage-link interwiki-ar mw-list-item"><a href="https://ar.wikipedia.org/wiki/%D9%86%D8%B8%D8%A7%D9%85_%D8%A5%D8%AF%D8%A7%D8%B1%D8%A9_%D8%A7%D9%84%D8%AC%D9%88%D8%AF%D8%A9" title="نظام إدارة الجودة – Arabic" lang="ar" hreflang="ar" data-title="نظام إدارة الجودة" data-language-autonym="العربية" data-language-local-name="Arabic" class="interlanguage-link-target"><span>العربية</span></a></li><li class="interlanguage-link interwiki-cs mw-list-item"><a href="https://cs.wikipedia.org/wiki/Syst%C3%A9m_%C5%99%C3%ADzen%C3%AD_jakosti" title="Systém řízení jakosti – Czech" lang="cs" hreflang="cs" data-title="Systém řízení jakosti" data-language-autonym="Čeština" data-language-local-name="Czech" class="interlanguage-link-target"><span>Čeština</span></a></li><li class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/Kvalitetsstyring" title="Kvalitetsstyring – Danish" lang="da" hreflang="da" data-title="Kvalitetsstyring" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/Qualit%C3%A4tsmanagementsystem" title="Qualitätsmanagementsystem – German" lang="de" hreflang="de" data-title="Qualitätsmanagementsystem" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Sistema_de_gesti%C3%B3n_de_la_calidad" title="Sistema de gestión de la calidad – Spanish" lang="es" hreflang="es" data-title="Sistema de gestión de la calidad" data-language-autonym="Español" data-language-local-name="Spanish" class="interlanguage-link-target"><span>Español</span></a></li><li class="interlanguage-link interwiki-eo mw-list-item"><a href="https://eo.wikipedia.org/wiki/Kvalito-rega_sistemo" title="Kvalito-rega sistemo – Esperanto" lang="eo" hreflang="eo" data-title="Kvalito-rega sistemo" data-language-autonym="Esperanto" data-language-local-name="Esperanto" class="interlanguage-link-target"><span>Esperanto</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%D8%B3%DB%8C%D8%B3%D8%AA%D9%85_%D9%85%D8%AF%DB%8C%D8%B1%DB%8C%D8%AA_%DA%A9%DB%8C%D9%81%DB%8C%D8%AA" title="سیستم مدیریت کیفیت – Persian" lang="fa" hreflang="fa" data-title="سیستم مدیریت کیفیت" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Syst%C3%A8me_de_management_de_la_qualit%C3%A9" title="Système de management de la qualité – French" lang="fr" hreflang="fr" data-title="Système de management de la qualité" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%ED%92%88%EC%A7%88_%EA%B4%80%EB%A6%AC_%EC%8B%9C%EC%8A%A4%ED%85%9C" title="품질 관리 시스템 – Korean" lang="ko" hreflang="ko" data-title="품질 관리 시스템" data-language-autonym="한국어" data-language-local-name="Korean" class="interlanguage-link-target"><span>한국어</span></a></li><li class="interlanguage-link interwiki-hy mw-list-item"><a href="https://hy.wikipedia.org/wiki/%D5%88%D6%80%D5%A1%D5%AF%D5%AB_%D5%AF%D5%A1%D5%BC%D5%A1%D5%BE%D5%A1%D6%80%D5%B4%D5%A1%D5%B6_%D5%B0%D5%A1%D5%B4%D5%A1%D5%AF%D5%A1%D6%80%D5%A3" title="Որակի կառավարման համակարգ – Armenian" lang="hy" hreflang="hy" data-title="Որակի կառավարման համակարգ" data-language-autonym="Հայերեն" data-language-local-name="Armenian" class="interlanguage-link-target"><span>Հայերեն</span></a></li><li class="interlanguage-link interwiki-hu mw-list-item"><a href="https://hu.wikipedia.org/wiki/Min%C5%91s%C3%A9gir%C3%A1ny%C3%ADt%C3%A1si_rendszer" title="Minőségirányítási rendszer – Hungarian" lang="hu" hreflang="hu" data-title="Minőségirányítási rendszer" data-language-autonym="Magyar" data-language-local-name="Hungarian" class="interlanguage-link-target"><span>Magyar</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E5%93%81%E8%B3%AA%E3%83%9E%E3%83%8D%E3%82%B8%E3%83%A1%E3%83%B3%E3%83%88%E3%82%B7%E3%82%B9%E3%83%86%E3%83%A0" title="品質マネジメントシステム – Japanese" lang="ja" hreflang="ja" data-title="品質マネジメントシステム" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-pl mw-list-item"><a href="https://pl.wikipedia.org/wiki/System_zarz%C4%85dzania_jako%C5%9Bci%C4%85" title="System zarządzania jakością – Polish" lang="pl" hreflang="pl" data-title="System zarządzania jakością" data-language-autonym="Polski" data-language-local-name="Polish" class="interlanguage-link-target"><span>Polski</span></a></li><li class="interlanguage-link interwiki-ro mw-list-item"><a href="https://ro.wikipedia.org/wiki/Sistem_de_management_al_calit%C4%83%C8%9Bii" title="Sistem de management al calității – Romanian" lang="ro" hreflang="ro" data-title="Sistem de management al calității" data-language-autonym="Română" data-language-local-name="Romanian" class="interlanguage-link-target"><span>Română</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/%D0%A1%D0%B8%D1%81%D1%82%D0%B5%D0%BC%D0%B0_%D0%BC%D0%B5%D0%BD%D0%B5%D0%B4%D0%B6%D0%BC%D0%B5%D0%BD%D1%82%D0%B0_%D0%BA%D0%B0%D1%87%D0%B5%D1%81%D1%82%D0%B2%D0%B0" title="Система менеджмента качества – Russian" lang="ru" hreflang="ru" data-title="Система менеджмента качества" data-language-autonym="Русский" data-language-local-name="Russian" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-sk mw-list-item"><a href="https://sk.wikipedia.org/wiki/Syst%C3%A9m_mana%C5%BE%C3%A9rstva_kvality" title="Systém manažérstva kvality – Slovak" lang="sk" hreflang="sk" data-title="Systém manažérstva kvality" data-language-autonym="Slovenčina" data-language-local-name="Slovak" class="interlanguage-link-target"><span>Slovenčina</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/Laatuj%C3%A4rjestelm%C3%A4" title="Laatujärjestelmä – Finnish" lang="fi" hreflang="fi" data-title="Laatujärjestelmä" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-sv mw-list-item"><a href="https://sv.wikipedia.org/wiki/Kvalitetssystem" title="Kvalitetssystem – Swedish" lang="sv" hreflang="sv" data-title="Kvalitetssystem" data-language-autonym="Svenska" data-language-local-name="Swedish" class="interlanguage-link-target"><span>Svenska</span></a></li><li class="interlanguage-link interwiki-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/Kalite_y%C3%B6netim_sistemi" title="Kalite yönetim sistemi – Turkish" lang="tr" hreflang="tr" data-title="Kalite yönetim sistemi" data-language-autonym="Türkçe" data-language-local-name="Turkish" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-uk mw-list-item"><a href="https://uk.wikipedia.org/wiki/%D0%A1%D0%B8%D1%81%D1%82%D0%B5%D0%BC%D0%B0_%D1%83%D0%BF%D1%80%D0%B0%D0%B2%D0%BB%D1%96%D0%BD%D0%BD%D1%8F_%D1%8F%D0%BA%D1%96%D1%81%D1%82%D1%8E" title="Система управління якістю – Ukrainian" lang="uk" hreflang="uk" data-title="Система управління якістю" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-vi mw-list-item"><a href="https://vi.wikipedia.org/wiki/H%E1%BB%87_th%E1%BB%91ng_qu%E1%BA%A3n_l%C3%BD_ch%E1%BA%A5t_l%C6%B0%E1%BB%A3ng" title="Hệ thống quản lý chất lượng – Vietnamese" lang="vi" hreflang="vi" data-title="Hệ thống quản lý chất lượng" data-language-autonym="Tiếng Việt" data-language-local-name="Vietnamese" class="interlanguage-link-target"><span>Tiếng Việt</span></a></li><li class="interlanguage-link interwiki-zh mw-list-item"><a href="https://zh.wikipedia.org/wiki/%E5%93%81%E8%B3%AA%E7%B3%BB%E7%B5%B1" title="品質系統 – Chinese" lang="zh" hreflang="zh" data-title="品質系統" data-language-autonym="中文" data-language-local-name="Chinese" class="interlanguage-link-target"><span>中文</span></a></li> </ul> <div class="after-portlet after-portlet-lang"><span class="wb-langlinks-edit wb-langlinks-link"><a href="https://www.wikidata.org/wiki/Special:EntityPage/Q608513#sitelinks-wikipedia" title="Edit interlanguage links" class="wbc-editpage">Edit links</a></span></div> </div> </div> </div> </header> <div class="vector-page-toolbar"> <div class="vector-page-toolbar-container"> <div id="left-navigation"> <nav aria-label="Namespaces"> <div id="p-associated-pages" class="vector-menu vector-menu-tabs mw-portlet mw-portlet-associated-pages" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-nstab-main" class="selected vector-tab-noicon mw-list-item"><a href="/wiki/Quality_management_system" title="View the content page [c]" accesskey="c"><span>Article</span></a></li><li id="ca-talk" class="vector-tab-noicon mw-list-item"><a href="/wiki/Talk:Quality_management_system" rel="discussion" title="Discuss improvements to the content page [t]" accesskey="t"><span>Talk</span></a></li> </ul> </div> </div> <div id="vector-variants-dropdown" class="vector-dropdown emptyPortlet" > <input type="checkbox" id="vector-variants-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-variants-dropdown" class="vector-dropdown-checkbox " aria-label="Change language variant" > <label id="vector-variants-dropdown-label" for="vector-variants-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet" aria-hidden="true" ><span class="vector-dropdown-label-text">English</span> </label> <div class="vector-dropdown-content"> <div id="p-variants" class="vector-menu mw-portlet mw-portlet-variants emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> </div> </div> </nav> </div> <div id="right-navigation" class="vector-collapsible"> <nav aria-label="Views"> <div id="p-views" class="vector-menu vector-menu-tabs mw-portlet mw-portlet-views" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-view" class="selected vector-tab-noicon mw-list-item"><a href="/wiki/Quality_management_system"><span>Read</span></a></li><li id="ca-edit" class="vector-tab-noicon mw-list-item"><a href="/w/index.php?title=Quality_management_system&action=edit" title="Edit this page [e]" accesskey="e"><span>Edit</span></a></li><li id="ca-history" class="vector-tab-noicon mw-list-item"><a href="/w/index.php?title=Quality_management_system&action=history" title="Past revisions of this page [h]" accesskey="h"><span>View history</span></a></li> </ul> </div> </div> </nav> <nav class="vector-page-tools-landmark" aria-label="Page tools"> <div id="vector-page-tools-dropdown" class="vector-dropdown vector-page-tools-dropdown" > <input type="checkbox" id="vector-page-tools-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-tools-dropdown" class="vector-dropdown-checkbox " aria-label="Tools" > <label id="vector-page-tools-dropdown-label" for="vector-page-tools-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet" aria-hidden="true" ><span class="vector-dropdown-label-text">Tools</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-tools-unpinned-container" class="vector-unpinned-container"> <div id="vector-page-tools" class="vector-page-tools vector-pinnable-element"> <div class="vector-pinnable-header vector-page-tools-pinnable-header vector-pinnable-header-unpinned" data-feature-name="page-tools-pinned" data-pinnable-element-id="vector-page-tools" data-pinned-container-id="vector-page-tools-pinned-container" data-unpinned-container-id="vector-page-tools-unpinned-container" > <div class="vector-pinnable-header-label">Tools</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-page-tools.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-page-tools.unpin">hide</button> </div> <div id="p-cactions" class="vector-menu mw-portlet mw-portlet-cactions emptyPortlet vector-has-collapsible-items" title="More options" > <div class="vector-menu-heading"> Actions </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-more-view" class="selected vector-more-collapsible-item mw-list-item"><a href="/wiki/Quality_management_system"><span>Read</span></a></li><li id="ca-more-edit" class="vector-more-collapsible-item mw-list-item"><a href="/w/index.php?title=Quality_management_system&action=edit" title="Edit this page [e]" accesskey="e"><span>Edit</span></a></li><li id="ca-more-history" class="vector-more-collapsible-item mw-list-item"><a href="/w/index.php?title=Quality_management_system&action=history"><span>View history</span></a></li> </ul> </div> </div> <div id="p-tb" class="vector-menu mw-portlet mw-portlet-tb" > <div class="vector-menu-heading"> General </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="t-whatlinkshere" class="mw-list-item"><a href="/wiki/Special:WhatLinksHere/Quality_management_system" title="List of all English Wikipedia pages containing links to this page [j]" accesskey="j"><span>What links here</span></a></li><li id="t-recentchangeslinked" class="mw-list-item"><a href="/wiki/Special:RecentChangesLinked/Quality_management_system" rel="nofollow" title="Recent changes in pages linked from this page [k]" accesskey="k"><span>Related changes</span></a></li><li id="t-upload" class="mw-list-item"><a href="/wiki/Wikipedia:File_Upload_Wizard" title="Upload files [u]" accesskey="u"><span>Upload file</span></a></li><li id="t-specialpages" class="mw-list-item"><a href="/wiki/Special:SpecialPages" title="A list of all special pages [q]" accesskey="q"><span>Special pages</span></a></li><li id="t-permalink" class="mw-list-item"><a href="/w/index.php?title=Quality_management_system&oldid=1252955422" title="Permanent link to this revision of this page"><span>Permanent link</span></a></li><li id="t-info" class="mw-list-item"><a href="/w/index.php?title=Quality_management_system&action=info" title="More information about this page"><span>Page information</span></a></li><li id="t-cite" class="mw-list-item"><a href="/w/index.php?title=Special:CiteThisPage&page=Quality_management_system&id=1252955422&wpFormIdentifier=titleform" title="Information on how to cite this page"><span>Cite this page</span></a></li><li id="t-urlshortener" class="mw-list-item"><a href="/w/index.php?title=Special:UrlShortener&url=https%3A%2F%2Fen.wikipedia.org%2Fwiki%2FQuality_management_system"><span>Get shortened URL</span></a></li><li id="t-urlshortener-qrcode" class="mw-list-item"><a href="/w/index.php?title=Special:QrCode&url=https%3A%2F%2Fen.wikipedia.org%2Fwiki%2FQuality_management_system"><span>Download QR code</span></a></li> </ul> </div> </div> <div id="p-coll-print_export" class="vector-menu mw-portlet mw-portlet-coll-print_export" > <div class="vector-menu-heading"> Print/export </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="coll-download-as-rl" class="mw-list-item"><a href="/w/index.php?title=Special:DownloadAsPdf&page=Quality_management_system&action=show-download-screen" title="Download this page as a PDF file"><span>Download as PDF</span></a></li><li id="t-print" class="mw-list-item"><a href="/w/index.php?title=Quality_management_system&printable=yes" title="Printable version of this page [p]" accesskey="p"><span>Printable version</span></a></li> </ul> </div> </div> <div id="p-wikibase-otherprojects" class="vector-menu mw-portlet mw-portlet-wikibase-otherprojects" > <div class="vector-menu-heading"> In other projects </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="t-wikibase" class="wb-otherproject-link wb-otherproject-wikibase-dataitem mw-list-item"><a href="https://www.wikidata.org/wiki/Special:EntityPage/Q608513" title="Structured data on this page hosted by Wikidata [g]" accesskey="g"><span>Wikidata item</span></a></li> </ul> </div> </div> </div> </div> </div> </div> </nav> </div> </div> </div> <div class="vector-column-end"> <div class="vector-sticky-pinned-container"> <nav class="vector-page-tools-landmark" aria-label="Page tools"> <div id="vector-page-tools-pinned-container" class="vector-pinned-container"> </div> </nav> <nav class="vector-appearance-landmark" aria-label="Appearance"> <div id="vector-appearance-pinned-container" class="vector-pinned-container"> <div id="vector-appearance" class="vector-appearance vector-pinnable-element"> <div class="vector-pinnable-header vector-appearance-pinnable-header vector-pinnable-header-pinned" data-feature-name="appearance-pinned" data-pinnable-element-id="vector-appearance" data-pinned-container-id="vector-appearance-pinned-container" data-unpinned-container-id="vector-appearance-unpinned-container" > <div class="vector-pinnable-header-label">Appearance</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-appearance.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-appearance.unpin">hide</button> </div> </div> </div> </nav> </div> </div> <div id="bodyContent" class="vector-body" aria-labelledby="firstHeading" data-mw-ve-target-container> <div class="vector-body-before-content"> <div class="mw-indicators"> </div> <div id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Sum of product fitness processes in a business</div> <style data-mw-deduplicate="TemplateStyles:r1251242444">.mw-parser-output .ambox{border:1px solid #a2a9b1;border-left:10px solid #36c;background-color:#fbfbfb;box-sizing:border-box}.mw-parser-output .ambox+link+.ambox,.mw-parser-output .ambox+link+style+.ambox,.mw-parser-output .ambox+link+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+style+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+link+.ambox{margin-top:-1px}html body.mediawiki .mw-parser-output .ambox.mbox-small-left{margin:4px 1em 4px 0;overflow:hidden;width:238px;border-collapse:collapse;font-size:88%;line-height:1.25em}.mw-parser-output .ambox-speedy{border-left:10px solid #b32424;background-color:#fee7e6}.mw-parser-output .ambox-delete{border-left:10px solid #b32424}.mw-parser-output .ambox-content{border-left:10px solid #f28500}.mw-parser-output .ambox-style{border-left:10px solid #fc3}.mw-parser-output .ambox-move{border-left:10px solid #9932cc}.mw-parser-output .ambox-protection{border-left:10px solid #a2a9b1}.mw-parser-output .ambox .mbox-text{border:none;padding:0.25em 0.5em;width:100%}.mw-parser-output .ambox .mbox-image{border:none;padding:2px 0 2px 0.5em;text-align:center}.mw-parser-output .ambox .mbox-imageright{border:none;padding:2px 0.5em 2px 0;text-align:center}.mw-parser-output .ambox .mbox-empty-cell{border:none;padding:0;width:1px}.mw-parser-output .ambox .mbox-image-div{width:52px}@media(min-width:720px){.mw-parser-output .ambox{margin:0 10%}}@media print{body.ns-0 .mw-parser-output .ambox{display:none!important}}</style><style data-mw-deduplicate="TemplateStyles:r1248332772">.mw-parser-output .multiple-issues-text{width:95%;margin:0.2em 0}.mw-parser-output .multiple-issues-text>.mw-collapsible-content{margin-top:0.3em}.mw-parser-output .compact-ambox .ambox{border:none;border-collapse:collapse;background-color:transparent;margin:0 0 0 1.6em!important;padding:0!important;width:auto;display:block}body.mediawiki .mw-parser-output .compact-ambox .ambox.mbox-small-left{font-size:100%;width:auto;margin:0}.mw-parser-output .compact-ambox .ambox .mbox-text{padding:0!important;margin:0!important}.mw-parser-output .compact-ambox .ambox .mbox-text-span{display:list-item;line-height:1.5em;list-style-type:disc}body.skin-minerva .mw-parser-output .multiple-issues-text>.mw-collapsible-toggle,.mw-parser-output .compact-ambox .ambox .mbox-image,.mw-parser-output .compact-ambox .ambox .mbox-imageright,.mw-parser-output .compact-ambox .ambox .mbox-empty-cell,.mw-parser-output .compact-ambox .hide-when-compact{display:none}</style><table class="box-Multiple_issues plainlinks metadata ambox ambox-content ambox-multiple_issues compact-ambox" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/b/b4/Ambox_important.svg/40px-Ambox_important.svg.png" decoding="async" width="40" height="40" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/b/b4/Ambox_important.svg/60px-Ambox_important.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/b/b4/Ambox_important.svg/80px-Ambox_important.svg.png 2x" data-file-width="40" data-file-height="40" /></span></span></div></td><td class="mbox-text"><div class="mbox-text-span"><div class="multiple-issues-text mw-collapsible"><b>This article has multiple issues.</b> Please help <b><a href="/wiki/Special:EditPage/Quality_management_system" title="Special:EditPage/Quality management system">improve it</a></b> or discuss these issues on the <b><a href="/wiki/Talk:Quality_management_system" title="Talk:Quality management system">talk page</a></b>. <small><i>(<a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove these messages</a>)</i></small> <div class="mw-collapsible-content"> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_footnotes_needed plainlinks metadata ambox ambox-style ambox-More_footnotes_needed" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/a/a4/Text_document_with_red_question_mark.svg/40px-Text_document_with_red_question_mark.svg.png" decoding="async" width="40" height="40" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/a/a4/Text_document_with_red_question_mark.svg/60px-Text_document_with_red_question_mark.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/a/a4/Text_document_with_red_question_mark.svg/80px-Text_document_with_red_question_mark.svg.png 2x" data-file-width="48" data-file-height="48" /></span></span></div></td><td class="mbox-text"><div class="mbox-text-span">This article includes a list of <a href="/wiki/Wikipedia:Citing_sources#General_references" title="Wikipedia:Citing sources">general references</a>, but <b>it lacks sufficient corresponding <a href="/wiki/Wikipedia:Citing_sources#Inline_citations" title="Wikipedia:Citing sources">inline citations</a></b>.<span class="hide-when-compact"> Please help to <a href="/wiki/Wikipedia:WikiProject_Reliability" title="Wikipedia:WikiProject Reliability">improve</a> this article by <a href="/wiki/Wikipedia:When_to_cite" title="Wikipedia:When to cite">introducing</a> more precise citations.</span> <span class="date-container"><i>(<span class="date">September 2010</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_citations_needed plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This article <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Quality_management_system" title="Special:EditPage/Quality management system">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a>. Unsourced material may be challenged and removed.<br /><small><span class="plainlinks"><i>Find sources:</i> <a rel="nofollow" class="external text" href="https://www.google.com/search?as_eq=wikipedia&q=%22Quality+management+system%22">"Quality management system"</a> – <a rel="nofollow" class="external text" href="https://www.google.com/search?tbm=nws&q=%22Quality+management+system%22+-wikipedia&tbs=ar:1">news</a> <b>·</b> <a rel="nofollow" class="external text" href="https://www.google.com/search?&q=%22Quality+management+system%22&tbs=bkt:s&tbm=bks">newspapers</a> <b>·</b> <a rel="nofollow" class="external text" href="https://www.google.com/search?tbs=bks:1&q=%22Quality+management+system%22+-wikipedia">books</a> <b>·</b> <a rel="nofollow" class="external text" href="https://scholar.google.com/scholar?q=%22Quality+management+system%22">scholar</a> <b>·</b> <a rel="nofollow" class="external text" href="https://www.jstor.org/action/doBasicSearch?Query=%22Quality+management+system%22&acc=on&wc=on">JSTOR</a></span></small></span> <span class="date-container"><i>(<span class="date">October 2020</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> </div> </div><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <p>A <b>quality management system</b> (<b>QMS</b>) is a collection of <a href="/wiki/Business_process" title="Business process">business processes</a> focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (<a href="/wiki/ISO_9000#Contents_of_ISO_9001:2015" class="mw-redirect" title="ISO 9000">ISO 9001:2015</a>).<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early <a href="/wiki/Quality_(business)" title="Quality (business)">quality</a> <a href="/wiki/Quality_management" title="Quality management">management</a> systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a <a href="/wiki/Continual_improvement" class="mw-redirect" title="Continual improvement">continual improvement</a> cycle. In the 21st century, QMS has tended to converge with <a href="/wiki/Sustainability" title="Sustainability">sustainability</a> and <a href="/wiki/Transparency_(behavior)" title="Transparency (behavior)">transparency</a> initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the <a href="/wiki/ISO_9000" class="mw-redirect" title="ISO 9000">ISO 9000</a> family of standards is probably the most widely implemented worldwide – the <a href="/wiki/ISO_19011" title="ISO 19011">ISO 19011</a> <a href="/wiki/Audit" title="Audit">audit</a> regime applies to both and deals with quality and sustainability and their integration. </p><p>Other QMS, e.g. <a href="/wiki/Natural_Step" class="mw-redirect" title="Natural Step">Natural Step</a>, focus on <a href="/wiki/Sustainability" title="Sustainability">sustainability</a> issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline. </p><p>The term "Quality Management System" and the initialism "QMS" were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Elements">Elements</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=1" title="Edit section: Elements"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ol><li><a href="/wiki/Quality_objectives" class="mw-redirect" title="Quality objectives">Quality objectives</a></li> <li>Quality manual</li> <li><a href="/wiki/Organizational_structure" title="Organizational structure">Organizational structure</a> and responsibilities</li> <li><a href="/wiki/Data_Management" class="mw-redirect" title="Data Management">Data management</a></li> <li>Processes – including purchasing</li> <li>Product quality leading to <a href="/wiki/Customer_satisfaction" title="Customer satisfaction">customer satisfaction</a></li> <li><a href="/wiki/Continuous_improvement" class="mw-redirect" title="Continuous improvement">Continuous improvement</a> including <a href="/wiki/Corrective_and_preventive_action" title="Corrective and preventive action">corrective and preventive action</a></li> <li>Quality instrument</li> <li>Document control</li> <li>Employee training and engagement</li> <li>Supplier quality management</li></ol> <div class="mw-heading mw-heading2"><h2 id="Concept_of_quality_–_historical_background"><span id="Concept_of_quality_.E2.80.93_historical_background"></span>Concept of quality – historical background</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=2" title="Edit section: Concept of quality – historical background"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The concept of a quality as we think of it now first emerged from the <a href="/wiki/Industrial_Revolution" title="Industrial Revolution">Industrial Revolution</a>. 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. In the late 19th century pioneers such as <a href="/wiki/Frederick_Winslow_Taylor" title="Frederick Winslow Taylor">Frederick Winslow Taylor</a> and <a href="/wiki/Henry_Ford" title="Henry Ford">Henry Ford</a> recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Birland established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects. </p><p>Application of statistical control came later as a result of World War production methods, which were advanced by the work done of <a href="/wiki/W._Edwards_Deming" title="W. Edwards Deming">W. Edwards Deming</a>, a <a href="/wiki/Statistician" title="Statistician">statistician</a>, after whom the <a href="/wiki/Deming_Prize" title="Deming Prize">Deming Prize</a> for quality is named. <a href="/wiki/Joseph_M._Juran" title="Joseph M. Juran">Joseph M. Juran</a> focused more on managing for quality. The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality. </p><p>Quality, as a profession and the managerial process associated with the quality function, was introduced during the second half of the 20th century and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession. </p><p>The quality profession grew from simple control to engineering, to systems engineering. <a href="/wiki/Quality_control" title="Quality control">Quality control</a> activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like <a href="/wiki/Medicine" title="Medicine">medicine</a>, <a href="/wiki/Accounting" title="Accounting">accounting</a>, and <a href="/wiki/Engineering" title="Engineering">engineering</a>, quality has achieved status as a recognized profession.<sup id="cite_ref-:0_2-0" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p><p>As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done.<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Medical_devices">Medical devices</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=3" title="Edit section: Medical devices"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the <a href="/wiki/ISO_13485" title="ISO 13485">ISO 13485</a> standards and the US FDA <a href="/wiki/21_CFR_820" class="mw-redirect" title="21 CFR 820">21 CFR 820</a> regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines. </p><p>ISO 13485 are harmonized with the European Union <a href="/wiki/Regulation_(EU)_2017/745" title="Regulation (EU) 2017/745">Regulation 2017/745</a> 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). </p><p>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 final rule published on October 7, 1996.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> The <a href="/wiki/U.S._Food_and_Drug_Administration" class="mw-redirect" title="U.S. Food and Drug Administration">U.S. Food and Drug Administration</a> (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 21 CFR 820.<sup id="cite_ref-:1_5-0" class="reference"><a href="#cite_note-:1-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>According to current <a href="/wiki/Good_Manufacturing_Practice" class="mw-redirect" title="Good Manufacturing Practice">Good Manufacturing Practice</a> (GMP), <a href="/wiki/Medical_device" title="Medical device">medical device</a> 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 Part 820 of the QS regulation.<sup id="cite_ref-:1_5-1" class="reference"><a href="#cite_note-:1-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> 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. </p><p>The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. These subsystems include: </p> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Qualsystem1.png" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/3/3f/Qualsystem1.png/220px-Qualsystem1.png" decoding="async" width="220" height="211" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/3/3f/Qualsystem1.png/330px-Qualsystem1.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/3/3f/Qualsystem1.png/440px-Qualsystem1.png 2x" data-file-width="547" data-file-height="524" /></a><figcaption>Quality system</figcaption></figure> <ul><li>Management controls;</li> <li><a href="/wiki/Design_controls" title="Design controls">Design controls</a>;</li> <li>Production and process controls</li> <li>Corrective and preventative actions</li> <li>Material controls</li> <li>Records, documents, and change controls</li> <li>Facilities and equipment controls</li></ul> <p>all overseen by management and quality audits. </p><p>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. </p><p>Drug manufacturers are regulated under a different section of the <a href="/wiki/Code_of_Federal_Regulations" title="Code of Federal Regulations">Code of Federal Regulations</a>: </p> <div class="mw-heading mw-heading2"><h2 id="Organizations_and_awards">Organizations and awards</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=4" title="Edit section: Organizations and awards"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable">See also: <a href="/wiki/List_of_national_quality_awards" title="List of national quality awards">List of national quality awards</a></div> <p>The <a href="/wiki/International_Organization_for_Standardization" title="International Organization for Standardization">International Organization for Standardization</a>'s <a href="/wiki/ISO_9001" class="mw-redirect" title="ISO 9001">ISO 9001:2015</a> series describes standards for a QMS addressing the principles and processes surrounding the <a href="/wiki/Design" title="Design">design</a>, <a href="/wiki/New_product_development" title="New product development">development</a>, and delivery of a general <a href="/wiki/Product_(business)" title="Product (business)">product</a> or <a href="/wiki/Service_(economics)" title="Service (economics)">service</a>. 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 (<a href="/wiki/Failure_mode_and_effects_analysis" title="Failure mode and effects analysis">FMEA</a>).<sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> </p><p>ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements. </p><p>The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the <a href="/wiki/Malcolm_Baldrige_National_Quality_Award" title="Malcolm Baldrige National Quality Award">Malcolm Baldrige National Quality Award</a>. 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. </p><p>The <a href="/wiki/European_Foundation_for_Quality_Management" class="mw-redirect" title="European Foundation for Quality Management">European Foundation for Quality Management</a>'s <a href="/wiki/EFQM_Excellence_Model" class="mw-redirect" title="EFQM Excellence Model">EFQM Excellence Model</a> supports an award scheme similar to the Baldrige Award for European companies. </p><p>In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and <a href="/wiki/Workplace_wellness" title="Workplace wellness">workplace wellness</a>, and have met the institute's criteria with documented overall achievements and results. </p><p>The European Quality in Social Service <a href="/wiki/European_Quality_in_Social_Services" title="European Quality in Social Services">(EQUASS</a>) is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to <a href="/wiki/Social_exclusion" title="Social exclusion">vulnerable groups</a>, such as empowerment, rights, and <a href="/wiki/Person-centred_planning" title="Person-centred planning">person-centredness</a>. </p><p>The Alliance for Performance Excellence is a network of state and local organizations that use the 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. </p> <div class="mw-heading mw-heading2"><h2 id="Process">Process</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=5" title="Edit section: Process"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>A QMS process is an element of an organizational QMS. The <a href="/wiki/ISO_9000" class="mw-redirect" title="ISO 9000">ISO 9001</a> standard requires organizations seeking <a href="/wiki/Compliance_(regulation)" class="mw-redirect" title="Compliance (regulation)">compliance</a> or <a href="/wiki/Certification" title="Certification">certification</a> to define the processes which form the QMS and the sequence and interaction of these processes. <a href="/wiki/Butterworth-Heinemann" title="Butterworth-Heinemann">Butterworth-Heinemann</a> and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.<sup id="cite_ref-i9sg_7-0" class="reference"><a href="#cite_note-i9sg-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-i9ib_8-0" class="reference"><a href="#cite_note-i9ib-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-i9ap_9-0" class="reference"><a href="#cite_note-i9ap-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-i9fsb_10-0" class="reference"><a href="#cite_note-i9fsb-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-i9qsh_11-0" class="reference"><a href="#cite_note-i9qsh-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-i9qrs_12-0" class="reference"><a href="#cite_note-i9qrs-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p><p>Examples of such processes include: </p><p>comply with specific requirements e.g. <a href="/wiki/Statistical_process_control" title="Statistical process control">statistical process control</a> and <a href="/wiki/Measurement_systems_analysis" class="mw-redirect" title="Measurement systems analysis">measurement systems analysis</a>, </p> <ul><li><a href="/wiki/Calibrations" class="mw-redirect" title="Calibrations">calibrations</a>,</li> <li><a href="/wiki/Corrective_and_preventive_action" title="Corrective and preventive action">corrective and preventive action</a>,</li> <li><a href="/wiki/Internal_audit" title="Internal audit">internal audit</a>,</li> <li>order processes,</li> <li><a href="/wiki/Product_(business)" title="Product (business)">product</a>/ <a href="/wiki/Service_(economics)" title="Service (economics)">service</a>/ <a href="/wiki/Process_modeling" title="Process modeling">process</a> measurements to</li> <li>identification, labeling and control of <a href="/wiki/Conformance_testing" title="Conformance testing">non-conforming</a> <a href="/wiki/Product_(business)" title="Product (business)">products</a> to prevent its inadvertent use, delivery or processing,</li> <li><a href="/wiki/Production_plan" class="mw-redirect" title="Production plan">production plans</a>,</li> <li><a href="/wiki/Purchasing" title="Purchasing">purchasing</a> and related processes such as <a href="/wiki/Distributor_(business)" class="mw-redirect" title="Distributor (business)">supplier</a> selection and <a href="https://en.wiktionary.org/wiki/monitoring" class="extiw" title="wikt:monitoring">monitoring</a></li></ul> <p>ISO 9001 requires that the performance of these processes be measured, analyzed and <a href="/wiki/Continuous_improvement" class="mw-redirect" title="Continuous improvement">continually improved</a>, and the results of this form an input into the <a href="/wiki/Management" title="Management">management</a> review process. </p> <div class="mw-heading mw-heading2"><h2 id="Software">Software</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=6" title="Edit section: Software"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Quality management <a href="/wiki/Software" title="Software">software</a> offers the techniques, processes, structure, and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively. </p><p>Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in the <a href="/wiki/Manufacturing" title="Manufacturing">manufacturing</a> industry to identify potential issues before they occur.<sup id="cite_ref-:1_5-2" class="reference"><a href="#cite_note-:1-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>Some benefits of quality management software include: </p> <ul><li>real-time data <a href="/wiki/Monitoring_and_evaluation" title="Monitoring and evaluation">monitoring</a></li> <li>issue prevention</li> <li>risk management</li> <li>increased efficiency and productivity</li> <li>process consistency</li> <li>increased employee participation</li></ul> <p>Quality management software can be integrated with manufacturing execution systems (MES). A <a href="/wiki/Manufacturing_execution_system" title="Manufacturing execution system">MES</a> is a complete, dynamic <a href="/wiki/Software" title="Software">software</a> system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products.<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> When combined with QMS, these systems: </p> <ul><li>ensure compliance</li> <li>enable quality programs</li> <li>eliminate <a href="/wiki/Waste" title="Waste">waste</a></li> <li>less product recalls</li> <li>lower per-product cost</li> <li>higher product quality</li> <li>product tracking</li> <li>real-time information for increase in quality control</li> <li>realistic production schedules</li> <li>up-to-date <a href="/wiki/Inventory" title="Inventory">inventory</a></li></ul> <p>Quality management software focuses on 4 main elements:<sup id="cite_ref-:0_2-1" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p> <ol><li><a href="/wiki/Document_management_system" title="Document management system">Document management</a>: Quality management software enables companies to manage all product and quality records and documents, including product specifications, work instructions, <a href="/wiki/Standard_operating_procedure" title="Standard operating procedure">standard operating procedures</a> (SOPs), quality policies, and training records, among other things, to fulfill highly regulated requirements. Quality management software <a href="/wiki/Centralized_database" title="Centralized database">centralizes</a> the storage of these documents.</li> <li><a href="/wiki/Regulatory_compliance" title="Regulatory compliance">Regulatory compliance</a>: To decrease compliance risks, quality management software is used within companies to make sure they comply with <a href="/wiki/ISO_9000" class="mw-redirect" title="ISO 9000">ISO</a>, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention.</li> <li><a href="/wiki/Feedback" title="Feedback">Feedback</a> loops: Quality management software permits staff to submit feedback or recommendations through <a href="/wiki/Centralisation" title="Centralisation">centralized</a> software. In turn, this way, managers gather insights from the shop floor creating a feedback loop.</li> <li>Training and <a href="/wiki/Skill" title="Skill">skill</a> management: To maintain product quality, quality management software can provide a fixed system through which employees and staff can be trained. This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees.</li></ol> <p>Most quality management software are cloud-based and offer <a href="/wiki/Software_as_a_service" title="Software as a service">software as a service</a>. </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=7" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/Capability_Maturity_Model_Integration" title="Capability Maturity Model Integration">Capability Maturity Model Integration</a></li> <li><a href="/wiki/Cleaner_production" title="Cleaner production">Cleaner production</a></li> <li><a href="/wiki/Good_manufacturing_practice" title="Good manufacturing practice">Good manufacturing practice</a></li> <li><a href="/wiki/ISO_14001" class="mw-redirect" title="ISO 14001">ISO 14001</a></li> <li><a href="/wiki/List_of_management_topics" class="mw-redirect" title="List of management topics">List of management topics</a></li> <li><a href="/wiki/List_of_national_quality_awards" title="List of national quality awards">List of national quality awards</a></li> <li><a href="/wiki/Manufacturing_process_management" title="Manufacturing process management">Manufacturing process management</a></li> <li><a href="/wiki/Positive_recall" title="Positive recall">Positive recall</a></li> <li><a href="/wiki/Process_architecture" title="Process architecture">Process architecture</a></li> <li><a href="/wiki/Quality_assurance" title="Quality assurance">Quality assurance</a></li> <li><a href="/wiki/Quality_control" title="Quality control">Quality control</a></li> <li><a href="/wiki/Software_quality" title="Software quality">Software quality</a></li> <li><a href="/wiki/Standard_operating_procedure" title="Standard operating procedure">Standard operating procedure</a></li> <li><a href="/wiki/Technical_documentation" title="Technical documentation">Technical documentation</a></li> <li><a href="/wiki/Total_quality_management" title="Total quality management">Total quality management</a></li> <li><a href="/wiki/Verification_and_validation" title="Verification and validation">Verification and validation</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=8" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.iso.org/standard/62085.html">"ISO 9001:2015"</a>. <i>ISO</i>. 2021-09-01<span class="reference-accessdate">. Retrieved <span class="nowrap">2023-07-08</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=ISO&rft.atitle=ISO+9001%3A2015&rft.date=2021-09-01&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F62085.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-:0-2"><span class="mw-cite-backlink">^ <a href="#cite_ref-:0_2-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-:0_2-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="http://prdweb.asq.org/certification/control/quality-engineer/index">"American Society for Quality (ASQ) Certified Quality Engineer (CQE)"</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=American+Society+for+Quality+%28ASQ%29+Certified+Quality+Engineer+%28CQE%29&rft_id=http%3A%2F%2Fprdweb.asq.org%2Fcertification%2Fcontrol%2Fquality-engineer%2Findex&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFLeeDale1998" class="citation journal cs1">Lee, R.G.; Dale, B.G. (1998). "Business process management: a review and evaluation". <i>Business Process Management Journal</i>. <b>4</b> (3): 214–225. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1108%2F14637159810224322">10.1108/14637159810224322</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Business+Process+Management+Journal&rft.atitle=Business+process+management%3A+a+review+and+evaluation&rft.volume=4&rft.issue=3&rft.pages=214-225&rft.date=1998&rft_id=info%3Adoi%2F10.1108%2F14637159810224322&rft.aulast=Lee&rft.aufirst=R.G.&rft.au=Dale%2C+B.G.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://ispe.org/">"Homepage | ISPE | International Society for Pharmaceutical Engineering"</a>. <i>ispe.org</i><span class="reference-accessdate">. Retrieved <span class="nowrap">2020-07-31</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=ispe.org&rft.atitle=Homepage+%7C+ISPE+%7C+International+Society+for+Pharmaceutical+Engineering&rft_id=https%3A%2F%2Fispe.org%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-:1-5"><span class="mw-cite-backlink">^ <a href="#cite_ref-:1_5-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-:1_5-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-:1_5-2"><sup><i><b>c</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://web.archive.org/web/20051124161242/http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html">"2005 CFR Title 21, Volume 8"</a>. 2005-11-24. Archived from <a rel="nofollow" class="external text" href="http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html">the original</a> on 2005-11-24.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=2005+CFR+Title+21%2C+Volume+8&rft.date=2005-11-24&rft_id=http%3A%2F%2Fwww.access.gpo.gov%2Fnara%2Fcfr%2Fwaisidx_05%2F21cfr820_05.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-6"><span class="mw-cite-backlink"><b><a href="#cite_ref-6">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFPoksinskaDahlgaardAntoni2002" class="citation journal cs1">Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organizations". <i>The TQM Magazine</i>. <b>14</b> (5): 297. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1108%2F09544780210439734">10.1108/09544780210439734</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=The+TQM+Magazine&rft.atitle=The+state+of+ISO+9000+certification%3A+A+study+of+Swedish+organizations&rft.volume=14&rft.issue=5&rft.pages=297&rft.date=2002&rft_id=info%3Adoi%2F10.1108%2F09544780210439734&rft.aulast=Poksinska&rft.aufirst=Bozena&rft.au=Dahlgaard%2C+Jens+J%C3%B6rn&rft.au=Antoni%2C+Marc&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9sg-7"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9sg_7-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFAntonCarole_Anton2006" class="citation book cs1">Anton, Doug; Carole Anton (2006). <i>ISO 9001 Survival Guide, Third Edition</i>. AEM Consulting Group, Inc. p. 100. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-9672170-8-6" title="Special:BookSources/978-0-9672170-8-6"><bdi>978-0-9672170-8-6</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9001+Survival+Guide%2C+Third+Edition&rft.pages=100&rft.pub=AEM+Consulting+Group%2C+Inc&rft.date=2006&rft.isbn=978-0-9672170-8-6&rft.aulast=Anton&rft.aufirst=Doug&rft.au=Carole+Anton&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9ib-8"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9ib_8-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFTrickerBruce_Sherring-Lucas2005" class="citation book cs1">Tricker, Ray; Bruce Sherring-Lucas (2005). <span class="id-lock-limited" title="Free access subject to limited trial, subscription normally required"><a rel="nofollow" class="external text" href="https://archive.org/details/isoauditprocedur00tric"><i>ISO 9001:2008 In Brief, Second Edition</i></a></span>. Butterworth-Heinemann. p. <a rel="nofollow" class="external text" href="https://archive.org/details/isoauditprocedur00tric/page/n210">192</a>. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-7506-6616-9" title="Special:BookSources/978-0-7506-6616-9"><bdi>978-0-7506-6616-9</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9001%3A2008+In+Brief%2C+Second+Edition&rft.pages=192&rft.pub=Butterworth-Heinemann&rft.date=2005&rft.isbn=978-0-7506-6616-9&rft.aulast=Tricker&rft.aufirst=Ray&rft.au=Bruce+Sherring-Lucas&rft_id=https%3A%2F%2Farchive.org%2Fdetails%2Fisoauditprocedur00tric&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9ap-9"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9ap_9-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFTricker2005" class="citation book cs1">Tricker, Ray (2005). <span class="id-lock-limited" title="Free access subject to limited trial, subscription normally required"><a rel="nofollow" class="external text" href="https://archive.org/details/isoauditprocedur00tric"><i>ISO 9001:2000 Audit Procedures, Second Edition</i></a></span>. Butterworth-Heinemann. p. <a rel="nofollow" class="external text" href="https://archive.org/details/isoauditprocedur00tric/page/n338">320</a>. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-7506-6615-2" title="Special:BookSources/978-0-7506-6615-2"><bdi>978-0-7506-6615-2</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9001%3A2000+Audit+Procedures%2C+Second+Edition&rft.pages=320&rft.pub=Butterworth-Heinemann&rft.date=2005&rft.isbn=978-0-7506-6615-2&rft.aulast=Tricker&rft.aufirst=Ray&rft_id=https%3A%2F%2Farchive.org%2Fdetails%2Fisoauditprocedur00tric&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9fsb-10"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9fsb_10-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFTricker2005" class="citation book cs1">Tricker, Ray (2005). <i>ISO 9001: 2000 For Small Businesses</i>. Butterworth-Heinemann. p. 480. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-7506-6617-6" title="Special:BookSources/978-0-7506-6617-6"><bdi>978-0-7506-6617-6</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9001%3A+2000+For+Small+Businesses&rft.pages=480&rft.pub=Butterworth-Heinemann&rft.date=2005&rft.isbn=978-0-7506-6617-6&rft.aulast=Tricker&rft.aufirst=Ray&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9qsh-11"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9qsh_11-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFHoyle2005" class="citation book cs1">Hoyle, David (2005). <i>ISO 9000 Quality Systems Handbook, Fifth Edition</i>. Butterworth-Heinemann. p. 686. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-7506-6785-2" title="Special:BookSources/978-0-7506-6785-2"><bdi>978-0-7506-6785-2</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9000+Quality+Systems+Handbook%2C+Fifth+Edition&rft.pages=686&rft.pub=Butterworth-Heinemann&rft.date=2005&rft.isbn=978-0-7506-6785-2&rft.aulast=Hoyle&rft.aufirst=David&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-i9qrs-12"><span class="mw-cite-backlink"><b><a href="#cite_ref-i9qrs_12-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFDobb2004" class="citation book cs1">Dobb, Fred (2004). <i>ISO 9001:2000 Quality Registration Step-by-Step, Third Edition</i>. Butterworth-Heinemann. p. 292. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-7506-4949-0" title="Special:BookSources/978-0-7506-4949-0"><bdi>978-0-7506-4949-0</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=ISO+9001%3A2000+Quality+Registration+Step-by-Step%2C+Third+Edition&rft.pages=292&rft.pub=Butterworth-Heinemann&rft.date=2004&rft.isbn=978-0-7506-4949-0&rft.aulast=Dobb&rft.aufirst=Fred&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> <li id="cite_note-13"><span class="mw-cite-backlink"><b><a href="#cite_ref-13">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://insights.sap.com/what-is-mes-manufacturing-execution-system/">"What Is an MES (Manufacturing Execution System)?"</a>. <i>SAP.com</i><span class="reference-accessdate">. Retrieved <span class="nowrap">23 March</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=SAP.com&rft.atitle=What+Is+an+MES+%28Manufacturing+Execution+System%29%3F&rft_id=https%3A%2F%2Finsights.sap.com%2Fwhat-is-mes-manufacturing-execution-system%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AQuality+management+system" class="Z3988"></span></span> </li> </ol></div></div> <div class="mw-heading mw-heading3"><h3 id="General_references">General references</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Quality_management_system&action=edit&section=9" title="Edit section: General references"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a rel="nofollow" class="external text" href="https://web.archive.org/web/20050208230203/http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e6_e.html">ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline</a> (and see <a href="/wiki/Clinical_Quality_Management_System" class="mw-redirect" title="Clinical Quality Management System">Clinical Quality Management System</a>)</li> <li>Pyzdek, T, "Quality Engineering Handbook", 2003, <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/0-8247-4614-7" title="Special:BookSources/0-8247-4614-7">0-8247-4614-7</a></li> <li>Juran, Joseph M. and De Feo, Joseph A., "Juran's Quality Handbook", 6th Edition, 1999, <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-07-162973-7" title="Special:BookSources/978-0-07-162973-7">978-0-07-162973-7</a></li> <li>Beernaerts, Indira (2022-02-16). "<a rel="nofollow" class="external text" href="https://www.azumuta.com/en/resources/blog/the-key-requirements-of-a-good-qms-system-for-manufacturing">The key requirements of a good QMS system for manufacturing</a>". <i>Azumuta</i>. Retrieved 2022-03-24.</li> <li>"<a rel="nofollow" class="external text" href="https://plm.sw.siemens.com/en-US/opcenter/quality/">Quality Management Systems</a>". <i>Siemens.com</i>. Retrieved 23 March 2022.</li> <li>"<a rel="nofollow" class="external text" href="https://insights.sap.com/what-is-mes-manufacturing-execution-system/">What Is en MES</a> (Manufacturing Execution System)?". <i>SAP.com</i>. 23 March 2022. Retrieved 23 March 2022.</li></ul> <div class="navbox-styles"><style data-mw-deduplicate="TemplateStyles:r1129693374">.mw-parser-output .hlist dl,.mw-parser-output .hlist ol,.mw-parser-output .hlist ul{margin:0;padding:0}.mw-parser-output .hlist dd,.mw-parser-output .hlist dt,.mw-parser-output .hlist li{margin:0;display:inline}.mw-parser-output .hlist.inline,.mw-parser-output .hlist.inline dl,.mw-parser-output .hlist.inline ol,.mw-parser-output .hlist.inline ul,.mw-parser-output .hlist dl dl,.mw-parser-output .hlist dl ol,.mw-parser-output .hlist dl ul,.mw-parser-output .hlist ol dl,.mw-parser-output .hlist ol ol,.mw-parser-output .hlist ol ul,.mw-parser-output .hlist ul dl,.mw-parser-output .hlist ul ol,.mw-parser-output .hlist ul ul{display:inline}.mw-parser-output .hlist .mw-empty-li{display:none}.mw-parser-output .hlist dt::after{content:": "}.mw-parser-output .hlist dd::after,.mw-parser-output .hlist li::after{content:" · ";font-weight:bold}.mw-parser-output .hlist dd:last-child::after,.mw-parser-output .hlist dt:last-child::after,.mw-parser-output .hlist li:last-child::after{content:none}.mw-parser-output .hlist dd dd:first-child::before,.mw-parser-output .hlist dd dt:first-child::before,.mw-parser-output .hlist dd li:first-child::before,.mw-parser-output .hlist dt dd:first-child::before,.mw-parser-output .hlist dt dt:first-child::before,.mw-parser-output .hlist dt li:first-child::before,.mw-parser-output .hlist li dd:first-child::before,.mw-parser-output .hlist li dt:first-child::before,.mw-parser-output .hlist li li:first-child::before{content:" (";font-weight:normal}.mw-parser-output .hlist dd dd:last-child::after,.mw-parser-output .hlist dd dt:last-child::after,.mw-parser-output .hlist dd li:last-child::after,.mw-parser-output .hlist dt dd:last-child::after,.mw-parser-output .hlist dt dt:last-child::after,.mw-parser-output .hlist dt li:last-child::after,.mw-parser-output .hlist li dd:last-child::after,.mw-parser-output .hlist li dt:last-child::after,.mw-parser-output .hlist li li:last-child::after{content:")";font-weight:normal}.mw-parser-output .hlist ol{counter-reset:listitem}.mw-parser-output .hlist ol>li{counter-increment:listitem}.mw-parser-output .hlist ol>li::before{content:" "counter(listitem)"\a0 "}.mw-parser-output .hlist dd ol>li:first-child::before,.mw-parser-output .hlist dt ol>li:first-child::before,.mw-parser-output .hlist li ol>li:first-child::before{content:" ("counter(listitem)"\a0 "}</style><style data-mw-deduplicate="TemplateStyles:r1236075235">.mw-parser-output .navbox{box-sizing:border-box;border:1px solid #a2a9b1;width:100%;clear:both;font-size:88%;text-align:center;padding:1px;margin:1em auto 0}.mw-parser-output .navbox .navbox{margin-top:0}.mw-parser-output .navbox+.navbox,.mw-parser-output .navbox+.navbox-styles+.navbox{margin-top:-1px}.mw-parser-output .navbox-inner,.mw-parser-output .navbox-subgroup{width:100%}.mw-parser-output .navbox-group,.mw-parser-output .navbox-title,.mw-parser-output .navbox-abovebelow{padding:0.25em 1em;line-height:1.5em;text-align:center}.mw-parser-output .navbox-group{white-space:nowrap;text-align:right}.mw-parser-output .navbox,.mw-parser-output .navbox-subgroup{background-color:#fdfdfd}.mw-parser-output .navbox-list{line-height:1.5em;border-color:#fdfdfd}.mw-parser-output .navbox-list-with-group{text-align:left;border-left-width:2px;border-left-style:solid}.mw-parser-output tr+tr>.navbox-abovebelow,.mw-parser-output tr+tr>.navbox-group,.mw-parser-output tr+tr>.navbox-image,.mw-parser-output tr+tr>.navbox-list{border-top:2px solid #fdfdfd}.mw-parser-output .navbox-title{background-color:#ccf}.mw-parser-output .navbox-abovebelow,.mw-parser-output .navbox-group,.mw-parser-output .navbox-subgroup .navbox-title{background-color:#ddf}.mw-parser-output .navbox-subgroup .navbox-group,.mw-parser-output .navbox-subgroup .navbox-abovebelow{background-color:#e6e6ff}.mw-parser-output .navbox-even{background-color:#f7f7f7}.mw-parser-output .navbox-odd{background-color:transparent}.mw-parser-output .navbox .hlist td dl,.mw-parser-output .navbox .hlist td ol,.mw-parser-output .navbox .hlist td ul,.mw-parser-output .navbox td.hlist dl,.mw-parser-output .navbox td.hlist ol,.mw-parser-output .navbox td.hlist ul{padding:0.125em 0}.mw-parser-output .navbox .navbar{display:block;font-size:100%}.mw-parser-output .navbox-title .navbar{float:left;text-align:left;margin-right:0.5em}body.skin--responsive .mw-parser-output .navbox-image img{max-width:none!important}@media print{body.ns-0 .mw-parser-output .navbox{display:none!important}}</style><style data-mw-deduplicate="TemplateStyles:r1038841319">.mw-parser-output .tooltip-dotted{border-bottom:1px dotted;cursor:help}</style></div><div role="navigation" class="navbox authority-control" aria-label="Navbox" style="padding:3px"><table class="nowraplinks hlist navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Help:Authority_control" title="Help:Authority control">Authority control databases</a>: National <span class="mw-valign-text-top noprint" typeof="mw:File/Frameless"><a href="https://www.wikidata.org/wiki/Q608513#identifiers" title="Edit this at Wikidata"><img alt="Edit this at Wikidata" src="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/10px-OOjs_UI_icon_edit-ltr-progressive.svg.png" decoding="async" width="10" height="10" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/15px-OOjs_UI_icon_edit-ltr-progressive.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/20px-OOjs_UI_icon_edit-ltr-progressive.svg.png 2x" data-file-width="20" data-file-height="20" /></a></span></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><ul><li><span class="uid"><span class="rt-commentedText tooltip tooltip-dotted" title="management jakosti"><a rel="nofollow" class="external text" href="https://aleph.nkp.cz/F/?func=find-c&local_base=aut&ccl_term=ica=ph115218&CON_LNG=ENG">Czech Republic</a></span></span></li></ul></div></td></tr></tbody></table></div>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?type=1x1" alt="" width="1" height="1" style="border: none; position: absolute;"></noscript> <div class="printfooter" data-nosnippet="">Retrieved from "<a dir="ltr" href="https://en.wikipedia.org/w/index.php?title=Quality_management_system&oldid=1252955422">https://en.wikipedia.org/w/index.php?title=Quality_management_system&oldid=1252955422</a>"</div></div> <div id="catlinks" class="catlinks" data-mw="interface"><div id="mw-normal-catlinks" class="mw-normal-catlinks"><a href="/wiki/Help:Category" title="Help:Category">Categories</a>: <ul><li><a href="/wiki/Category:Quality_management" title="Category:Quality management">Quality management</a></li><li><a href="/wiki/Category:Engineering_management" title="Category:Engineering management">Engineering management</a></li></ul></div><div id="mw-hidden-catlinks" class="mw-hidden-catlinks mw-hidden-cats-hidden">Hidden categories: <ul><li><a href="/wiki/Category:Articles_with_short_description" title="Category:Articles with short description">Articles with short description</a></li><li><a href="/wiki/Category:Short_description_is_different_from_Wikidata" title="Category:Short description is different from Wikidata">Short description is different from Wikidata</a></li><li><a href="/wiki/Category:Articles_lacking_in-text_citations_from_September_2010" title="Category:Articles lacking in-text citations from September 2010">Articles lacking in-text citations from September 2010</a></li><li><a href="/wiki/Category:All_articles_lacking_in-text_citations" title="Category:All articles lacking in-text citations">All articles lacking in-text citations</a></li><li><a href="/wiki/Category:Articles_needing_additional_references_from_October_2020" title="Category:Articles needing additional references from October 2020">Articles needing additional references from October 2020</a></li><li><a href="/wiki/Category:All_articles_needing_additional_references" title="Category:All articles needing additional references">All articles needing additional references</a></li><li><a href="/wiki/Category:Articles_with_multiple_maintenance_issues" title="Category:Articles with multiple maintenance issues">Articles with multiple maintenance issues</a></li></ul></div></div> </div> </main> </div> <div class="mw-footer-container"> <footer id="footer" class="mw-footer" > <ul id="footer-info"> <li id="footer-info-lastmod"> This page was last edited on 23 October 2024, at 18:07<span class="anonymous-show"> (UTC)</span>.</li> <li id="footer-info-copyright">Text is available under the <a href="/wiki/Wikipedia:Text_of_the_Creative_Commons_Attribution-ShareAlike_4.0_International_License" title="Wikipedia:Text of the Creative Commons Attribution-ShareAlike 4.0 International License">Creative Commons Attribution-ShareAlike 4.0 License</a>; additional terms may apply. By using this site, you agree to the <a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Terms_of_Use" class="extiw" title="foundation:Special:MyLanguage/Policy:Terms of Use">Terms of Use</a> and <a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Privacy_policy" class="extiw" title="foundation:Special:MyLanguage/Policy:Privacy policy">Privacy Policy</a>. Wikipedia® is a registered trademark of the <a rel="nofollow" class="external text" href="https://wikimediafoundation.org/">Wikimedia Foundation, Inc.</a>, a non-profit organization.</li> </ul> <ul id="footer-places"> <li id="footer-places-privacy"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Privacy_policy">Privacy policy</a></li> <li id="footer-places-about"><a href="/wiki/Wikipedia:About">About Wikipedia</a></li> <li id="footer-places-disclaimers"><a href="/wiki/Wikipedia:General_disclaimer">Disclaimers</a></li> <li id="footer-places-contact"><a href="//en.wikipedia.org/wiki/Wikipedia:Contact_us">Contact Wikipedia</a></li> <li id="footer-places-wm-codeofconduct"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Universal_Code_of_Conduct">Code of Conduct</a></li> <li id="footer-places-developers"><a href="https://developer.wikimedia.org">Developers</a></li> <li id="footer-places-statslink"><a href="https://stats.wikimedia.org/#/en.wikipedia.org">Statistics</a></li> <li id="footer-places-cookiestatement"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Cookie_statement">Cookie statement</a></li> <li id="footer-places-mobileview"><a href="//en.m.wikipedia.org/w/index.php?title=Quality_management_system&mobileaction=toggle_view_mobile" class="noprint stopMobileRedirectToggle">Mobile view</a></li> </ul> <ul id="footer-icons" class="noprint"> <li id="footer-copyrightico"><a href="https://wikimediafoundation.org/" class="cdx-button cdx-button--fake-button cdx-button--size-large cdx-button--fake-button--enabled"><img src="/static/images/footer/wikimedia-button.svg" width="84" height="29" alt="Wikimedia Foundation" loading="lazy"></a></li> <li id="footer-poweredbyico"><a href="https://www.mediawiki.org/" class="cdx-button cdx-button--fake-button cdx-button--size-large cdx-button--fake-button--enabled"><img src="/w/resources/assets/poweredby_mediawiki.svg" alt="Powered by MediaWiki" width="88" height="31" loading="lazy"></a></li> </ul> </footer> </div> </div> </div> <div class="vector-settings" id="p-dock-bottom"> <ul></ul> </div><script>(RLQ=window.RLQ||[]).push(function(){mw.config.set({"wgHostname":"mw-web.codfw.main-f69cdc8f6-twlxc","wgBackendResponseTime":163,"wgPageParseReport":{"limitreport":{"cputime":"0.461","walltime":"0.568","ppvisitednodes":{"value":1765,"limit":1000000},"postexpandincludesize":{"value":57346,"limit":2097152},"templateargumentsize":{"value":9958,"limit":2097152},"expansiondepth":{"value":18,"limit":100},"expensivefunctioncount":{"value":4,"limit":500},"unstrip-depth":{"value":1,"limit":20},"unstrip-size":{"value":60812,"limit":5000000},"entityaccesscount":{"value":1,"limit":400},"timingprofile":["100.00% 509.299 1 -total"," 34.79% 177.164 1 Template:Reflist"," 21.04% 107.142 5 Template:Cite_web"," 19.89% 101.301 1 Template:Multiple_issues"," 19.61% 99.852 1 Template:Authority_control"," 15.28% 77.819 1 Template:Short_description"," 13.18% 67.104 2 Template:Ambox"," 10.61% 54.050 1 Template:More_footnotes_needed"," 9.71% 49.457 2 Template:Pagetype"," 6.34% 32.306 6 Template:Cite_book"]},"scribunto":{"limitreport-timeusage":{"value":"0.307","limit":"10.000"},"limitreport-memusage":{"value":6421372,"limit":52428800}},"cachereport":{"origin":"mw-web.codfw.main-f69cdc8f6-r5q8s","timestamp":"20241122141217","ttl":2592000,"transientcontent":false}}});});</script> <script type="application/ld+json">{"@context":"https:\/\/schema.org","@type":"Article","name":"Quality management system","url":"https:\/\/en.wikipedia.org\/wiki\/Quality_management_system","sameAs":"http:\/\/www.wikidata.org\/entity\/Q608513","mainEntity":"http:\/\/www.wikidata.org\/entity\/Q608513","author":{"@type":"Organization","name":"Contributors to Wikimedia projects"},"publisher":{"@type":"Organization","name":"Wikimedia Foundation, Inc.","logo":{"@type":"ImageObject","url":"https:\/\/www.wikimedia.org\/static\/images\/wmf-hor-googpub.png"}},"datePublished":"2001-09-18T21:20:12Z","dateModified":"2024-10-23T18:07:20Z","headline":"business processes focused on meeting customer requirements and enhancing satisfaction"}</script> </body> </html>