{"id":16656,"date":"2026-07-18T13:08:28","date_gmt":"2026-07-18T11:08:28","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/qmsr-begriff\/"},"modified":"2026-07-19T21:03:00","modified_gmt":"2026-07-19T19:03:00","slug":"qmsr","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/qmsr\/","title":{"rendered":"QMSR"},"content":{"rendered":"<p>The <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services.\" class=\"encyclopedia\">Quality Management<\/a> System Regulation (QMSR) is the U.S. regulation of the quality management system for medical devices &ndash; 21 CFR Part 820, effective February 2, 2026. It replaces the previous <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word \"qualitas\", which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent characteristics of an object meets requirements. Inherent means \"intrinsic to a particular unit\".' class=\"encyclopedia\">Quality<\/a> System Regulation by directly incorporating the requirements of ISO 13485:2016 &ndash; a QMS built on ISO 13485 thus fulfills the core of the U.S. obligation. Telling is the first obligation in &sect; 820.10: it reads, literally, &ldquo;Document.&rdquo; &ndash; a verb: the QMS is to be documented, not a document to be delivered. The old document control section &sect; 820.40 is gone ([Reserved]). For software in production and the QMS, the FDA CSA guidance describes the risk-based evidence approach under the QMSR.<\/p>\n<p><em>See also: <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\" target=\"_self\" title=\"Computer Software Assurance is the FDA's risk-based approach for establishing and maintaining confidence that software is fit for its Intended Use - in the guidance's own wording, the Intended Use of the software as part of production or the quality management system, explicitly distinguished from the intended use of the medical device itself. The effort&hellip;\" class=\"encyclopedia\">Computer Software Assurance (CSA)<\/a>, Quality Management.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Quality Management System Regulation (QMSR) is the U.S. regulation of the quality management system for medical devices &#8211; 21 CFR Part 820, effective February 2, 2026. It replaces the previous Quality System Regulation by directly incorporating the requirements of ISO 13485:2016 &#8211; a QMS built on ISO 13485 thus fulfills the core of the [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16656","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>QMSR: 21 CFR Part 820 Meets ISO 13485 | QFINITY<\/title>\n<meta name=\"description\" content=\"QMSR: since February 2, 2026, 21 CFR Part 820 directly incorporates ISO 13485:2016 - what the Quality Management System Regulation means for a medical device QMS.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/glossar\/qmsr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"QMSR: 21 CFR Part 820 Meets ISO 13485 | QFINITY\" \/>\n<meta property=\"og:description\" content=\"QMSR: since February 2, 2026, 21 CFR Part 820 directly incorporates ISO 13485:2016 - what the Quality Management System Regulation means for a medical device QMS.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/glossar\/qmsr\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-19T19:03:00+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"QMSR\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/qmsr\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/qmsr\\\/\",\"name\":\"QMSR: 21 CFR Part 820 Meets ISO 13485 | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"datePublished\":\"2026-07-18T11:08:28+00:00\",\"dateModified\":\"2026-07-19T19:03:00+00:00\",\"description\":\"QMSR: since February 2, 2026, 21 CFR Part 820 directly incorporates ISO 13485:2016 - what the Quality Management System Regulation means for a medical device QMS.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/qmsr\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/qmsr\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/qmsr\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Glossar\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/glossar\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"QMSR\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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