{"id":1645,"date":"2023-08-06T04:15:31","date_gmt":"2023-08-06T03:15:31","guid":{"rendered":"https:\/\/cinabiso.co.in\/?page_id=1645"},"modified":"2024-05-29T07:23:42","modified_gmt":"2024-05-29T06:23:42","slug":"iso-13485-2016","status":"publish","type":"page","link":"https:\/\/cinabiso.co.in\/?page_id=1645","title":{"rendered":"ISO 13485 : 2016"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1645\" class=\"elementor elementor-1645\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ef95f03 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no\" data-id=\"ef95f03\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;tilt&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0,6V0h1000v100L0,6z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c8dd92e\" data-id=\"c8dd92e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3de19c3 elementor-widget elementor-widget-heading\" data-id=\"3de19c3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 14-09-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485:2016<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9572656 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no\" data-id=\"9572656\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ecd14f9\" data-id=\"ecd14f9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa91b36 elementor-widget elementor-widget-heading\" data-id=\"aa91b36\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485: 2016 MDQMS<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec0e276 elementor-widget elementor-widget-text-editor\" data-id=\"ec0e276\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 14-09-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<div class=\"elementor-element elementor-element-1aa9d1a elementor-widget elementor-widget-text-editor\" data-id=\"1aa9d1a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>ISO 13485:2016 (Medical Devices \u2013 Quality Management Systems \u2013 Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices.<\/p><p>The latest version of the standard, was published in March 2016. It shares the same QMS principles and also follows the general increased emphasis on risk management shown within the range of QMS standards. It has not, however, adopted the Annex SL high level structure reflected within ISO 9001:2015.<\/p><p>ISO 13485 was originally derived from ISO 9001 and shared the same basic principles, but required greater documentation and placed additional emphasis on areas such as the work environment, risk management, design control and regulatory requirements.<\/p><\/div><\/div><div>\u00a0<\/div><div>\u00a0<\/div><div>\u00a0<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-96a3337 elementor-hidden-tablet elementor-hidden-mobile\" data-id=\"96a3337\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d92e111 elementor-widget elementor-widget-image\" data-id=\"d92e111\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 14-09-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"355\" height=\"355\" src=\"https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-355x355.webp\" class=\"attachment-meafe-category-tab size-meafe-category-tab wp-image-3533\" alt=\"\" srcset=\"https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-355x355.webp 355w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-150x150.webp 150w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-370x370.webp 370w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-170x170.webp 170w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2024\/05\/ISO-Logo-13485-2016-300x300.webp 300w\" sizes=\"(max-width: 355px) 100vw, 355px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 13485:2016 ISO 13485: 2016 MDQMS ISO 13485:2016 (Medical Devices \u2013 Quality Management Systems \u2013 Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/1645"}],"collection":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1645"}],"version-history":[{"count":28,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/1645\/revisions"}],"predecessor-version":[{"id":3819,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/1645\/revisions\/3819"}],"wp:attachment":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1645"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}