{"id":7446,"date":"2021-06-23T16:57:32","date_gmt":"2021-06-23T14:57:32","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=7446"},"modified":"2023-06-29T17:30:28","modified_gmt":"2023-06-29T15:30:28","slug":"quality-management-systems-requirements-and-certification-according-to-en-iso-13485","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2021\/06\/23\/quality-management-systems-requirements-and-certification-according-to-en-iso-13485\/","title":{"rendered":"Quality management systems &#8211; Requirements and certification according to EN ISO 13485"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-c20e1e4506bf8889e839d22fb828992a\">\n.avia-section.av-kkwbho9e-c20e1e4506bf8889e839d22fb828992a{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/06\/shutterstock_344500622-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-kkwbho9e-c20e1e4506bf8889e839d22fb828992a .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-c20e1e4506bf8889e839d22fb828992a main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7446'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-bjkpou-4d21ae85a694f724a081997bbbff889f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7446'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r4r66-90380a229f4631b5c0d2990376471ae0\">\n.flex_column.av-9r4r66-90380a229f4631b5c0d2990376471ae0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9r4r66-90380a229f4631b5c0d2990376471ae0 av_four_fifth  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kq9khzvz-92bf6eadd517279af3e693429dbfeee7\">\n#top .av-special-heading.av-kq9khzvz-92bf6eadd517279af3e693429dbfeee7{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kq9khzvz-92bf6eadd517279af3e693429dbfeee7 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kq9khzvz-92bf6eadd517279af3e693429dbfeee7 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kq9khzvz-92bf6eadd517279af3e693429dbfeee7 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Quality management systems &#8211; Requirements and certification according to EN ISO 13485<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-4  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In order for your medical devices to be approved in important markets, proven quality management for the design and manufacture of your product is essential. For this, EN ISO 13485 sets requirements for regulatory purposes.<\/p>\n<p>Accordingly, the standard deals with requirements that you as a manufacturer must fulfil in order to meet the quality requirements in the development and implementation of management systems for medical devices. EN ISO 13485 was first developed in 1996.<\/p>\n<p>In the meantime, several standards have been combined under it, including ISO 13488. Certification according to ISO 13485 is carried out by accredited certification bodies, such as DQS or T\u00dcV.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6ypsa6-daa0fc30a3e7324da5f6d2e69cffb770\">\n.avia-section.av-6ypsa6-daa0fc30a3e7324da5f6d2e69cffb770{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/10\/shutterstock_270633650-scaled.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-daa0fc30a3e7324da5f6d2e69cffb770 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-daa0fc30a3e7324da5f6d2e69cffb770 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-6  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7446'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-7  el_before_av_one_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kq9km227-75610144df43d674dff73be3ec39b429\">\n#top .av-special-heading.av-kq9km227-75610144df43d674dff73be3ec39b429{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kq9km227-75610144df43d674dff73be3ec39b429 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kq9km227-75610144df43d674dff73be3ec39b429 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kq9km227-75610144df43d674dff73be3ec39b429 av-special-heading-h3 blockquote modern-quote  avia-builder-el-8  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Requirements according to EN ISO 13485<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kq9k1iff-30180044fdd3575dfb8c24e01dba568c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>ISO 13485 defines four process areas. Each of these areas contains several processes that you as a manufacturer of medical devices must define. This can be done, for example, in the form of a process instruction. With such an instruction, companies define specific processes, e.g. for product development or services.<\/p>\n<p>The four process areas according to EN ISO 13485 are:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-kq9jq2bz-e7bba399ff15ef817c53cd400e32c5c2  avia-builder-el-10  el_after_av_textblock  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-kq9jq2bz-e7bba399ff15ef817c53cd400e32c5c2 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-6vyk1y-ce8efd47e8759a051b2645168d84e406 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Management responsibility\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Management responsibility<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-6gyfly-f968e5340ac96b967db8c962bedda087 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue822' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Resource management \"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Resource management <\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-cvz9y-b8f296dbd47f4501bd671458474e9592 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue855' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Product realisation and service provision \"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Product realisation and service provision <\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-34vy1i-d88b76e5e10ed7a8bcf37df50c86a17c avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8d1' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Measurement, analysis and improvement\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Measurement, analysis and improvement<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-85b3d8d408f80152e13fe296657fc778\">\n.flex_column.av-bcmscg-85b3d8d408f80152e13fe296657fc778{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-85b3d8d408f80152e13fe296657fc778 av_one_fourth  avia-builder-el-11  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-6ypsa6-98695f771d14b674197121c82d95ada8 main_color avia-section-default avia-no-border-styling  avia-builder-el-12  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7446'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-13  el_before_av_three_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kq9kod3b-d177f1586eea9d6e984f786268779ede\">\n#top .av-special-heading.av-kq9kod3b-d177f1586eea9d6e984f786268779ede{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kq9kod3b-d177f1586eea9d6e984f786268779ede .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kq9kod3b-d177f1586eea9d6e984f786268779ede .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kq9kod3b-d177f1586eea9d6e984f786268779ede av-special-heading-h3 blockquote modern-quote  avia-builder-el-14  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Certification according to EN ISO 13485<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In order to obtain certification according to EN ISO 13485, it is first necessary that you select a notified body or certifier that is accredited for such certification. According to the German accreditation body DaKKs, there are currently 17 certifiers in Germany.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-0468f276c05b1b9ae2f08aed2f4e0058\">\n@keyframes av_boxShadowEffect_av-bcmscg-0468f276c05b1b9ae2f08aed2f4e0058-column {\n0%   { box-shadow:  0 0 0 0 #000000; opacity: 1; }\n100% { box-shadow:  0 0 5px 0 #000000; opacity: 1; }\n}\n.flex_column.av-bcmscg-0468f276c05b1b9ae2f08aed2f4e0058{\nbox-shadow: 0 0 5px 0 #000000;\nborder-width:2px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:0px 0px 0px 0px;\npadding:20px 20px 20px 20px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-0468f276c05b1b9ae2f08aed2f4e0058 av_three_fourth  avia-builder-el-16  el_after_av_three_fourth  el_before_av_three_fourth  first flex_column_div shadow-not-animated  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kq9jsssp-0e92c5187eedf80b9f389165320dff43\">\n.iconbox.av-kq9jsssp-0e92c5187eedf80b9f389165320dff43 .iconbox_icon{\nborder:1px solid #ffffff;\n}\n<\/style>\n<article  class='iconbox iconbox_left av-kq9jsssp-0e92c5187eedf80b9f389165320dff43  avia-builder-el-17  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Did you know \u2026? \"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue864' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Did you know \u2026? <\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>&#8230; that certified bodies are only allowed to carry out certification according to EN ISO 13485 for a certain type of medical devices? For in-vitro diagnostics, for example, these are Medcert, T\u00dcV Rheinland, T\u00dcV S\u00fcd, mdc and Dekra.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-18  el_after_av_three_fourth  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><p><section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In order to obtain certification from the body you have chosen, you invite them to an audit in which their quality management system is examined. After successful audit and certification, you are authorised to place your medical devices on the market.<\/p>\n<p>In order to apply for an audit, you must not only establish and define your quality management system, but already act according to the specifications of this system.<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kq9jv3fi-c04d56677bd1a566f449e3caa401bd18 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>This includes, for example, that you have already created a technical documentation of your medical device. This is where the <a href=\"https:\/\/www.riskmanager.net\/en\/solution\/the-validated-approval-accelerator\/\" target=\"_blank\" rel=\"noopener\"><strong>BAYOOSOFT Risk Manager<\/strong><\/a> supports you.<\/p>\n<p>The validated approval accelerator is certified according to EN ISO 13485 and is thus the optimal supplement for your quality management system. 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