{"id":847,"date":"2019-11-13T06:26:52","date_gmt":"2019-11-13T06:26:52","guid":{"rendered":"https:\/\/www.iso-saudi.net\/blog\/?p=847"},"modified":"2019-11-13T06:26:52","modified_gmt":"2019-11-13T06:26:52","slug":"general-qms-requirements-for-iso-13485","status":"publish","type":"post","link":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/","title":{"rendered":"General QMS Requirements For ISO 13485"},"content":{"rendered":"<p>For medical device manufacturers in Saudi Arabia, the <a href=\"https:\/\/www.iso-saudi.net\/blog\/iso-13485-things-to-know\/\">ISO 13485 certification<\/a> is one of the required Quality Management System (QMS) standards. The following are some of the general QMS requirements for obtaining the certificate:<\/p>\n<ul>\n<li>Always maintain the specified standard.<\/li>\n<li>Identify and minimize risk.<\/li>\n<li>Always have written documentation of the active protocols and procedures.<\/li>\n<li>Remember to adhere to all legal requirements.<\/li>\n<li>Maintain responsibility for outsourced tasks.<\/li>\n<\/ul>\n<p>These are some of the general requirements that must be fulfilled to get the certificate. For complete guidance on the process, it\u2019s best to contact top ISO 13485 consultants in Saudi Arabia.<\/p>\n<p>For ISO 13485 Certification, ISO 13485 Consultancy,\u00a0ISO 13485 Consultants, ISO 13485 SFDA requirements, in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf drop an email to\u00a0<strong>info@iso-saudi.net<\/strong>.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For medical device manufacturers in Saudi Arabia, the ISO 13485 certification is one of the required Quality Management System (QMS) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[131],"tags":[138,125,256,142,241,240],"class_list":["post-847","post","type-post","status-publish","format-standard","hentry","category-iso-13485","tag-iso-13485-certificate","tag-iso-13485-certification","tag-iso-13485-consultant","tag-iso-13485-consultants","tag-saudi-food-and-drug-authority","tag-sfda"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>General QMS Requirements For ISO 13485 - ISO Saudi Arabia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"General QMS Requirements For ISO 13485 - ISO Saudi Arabia\" \/>\n<meta property=\"og:description\" content=\"For medical device manufacturers in Saudi Arabia, the ISO 13485 certification is one of the required Quality Management System (QMS) [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\" \/>\n<meta property=\"og:site_name\" content=\"ISO Saudi Arabia\" \/>\n<meta property=\"article:published_time\" content=\"2019-11-13T06:26:52+00:00\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/person\/d8b33624737a3c0e53b36522a4f404fd\"},\"headline\":\"General QMS Requirements For ISO 13485\",\"datePublished\":\"2019-11-13T06:26:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\"},\"wordCount\":126,\"publisher\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#organization\"},\"keywords\":[\"iso 13485 certificate\",\"ISO 13485 Certification\",\"ISO 13485 Consultant\",\"ISO 13485 Consultants\",\"Saudi Food and Drug Authority\",\"SFDA\"],\"articleSection\":[\"ISO 13485\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\",\"url\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\",\"name\":\"General QMS Requirements For ISO 13485 - ISO Saudi Arabia\",\"isPartOf\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#website\"},\"datePublished\":\"2019-11-13T06:26:52+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.iso-saudi.net\/blog\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"General QMS Requirements For ISO 13485\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#website\",\"url\":\"https:\/\/www.iso-saudi.net\/blog\/\",\"name\":\"ISO Saudi Arabia\",\"description\":\"ISO Saudi Arabia\",\"publisher\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.iso-saudi.net\/blog\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#organization\",\"name\":\"ISO Saudi Arabia\",\"url\":\"https:\/\/www.iso-saudi.net\/blog\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.iso-saudi.net\/blog\/wp-content\/uploads\/2019\/11\/logo-1.png\",\"contentUrl\":\"https:\/\/www.iso-saudi.net\/blog\/wp-content\/uploads\/2019\/11\/logo-1.png\",\"width\":181,\"height\":38,\"caption\":\"ISO Saudi Arabia\"},\"image\":{\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/person\/d8b33624737a3c0e53b36522a4f404fd\",\"name\":\"admin\",\"sameAs\":[\"http:\/\/9558030567f6cd9afb9be1c2f5fc56bf\"],\"url\":\"https:\/\/www.iso-saudi.net\/blog\/author\/admin\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"General QMS Requirements For ISO 13485 - ISO Saudi Arabia","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/","og_locale":"en_US","og_type":"article","og_title":"General QMS Requirements For ISO 13485 - ISO Saudi Arabia","og_description":"For medical device manufacturers in Saudi Arabia, the ISO 13485 certification is one of the required Quality Management System (QMS) [&hellip;]","og_url":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/","og_site_name":"ISO Saudi Arabia","article_published_time":"2019-11-13T06:26:52+00:00","author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#article","isPartOf":{"@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/"},"author":{"name":"admin","@id":"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/person\/d8b33624737a3c0e53b36522a4f404fd"},"headline":"General QMS Requirements For ISO 13485","datePublished":"2019-11-13T06:26:52+00:00","mainEntityOfPage":{"@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/"},"wordCount":126,"publisher":{"@id":"https:\/\/www.iso-saudi.net\/blog\/#organization"},"keywords":["iso 13485 certificate","ISO 13485 Certification","ISO 13485 Consultant","ISO 13485 Consultants","Saudi Food and Drug Authority","SFDA"],"articleSection":["ISO 13485"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/","url":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/","name":"General QMS Requirements For ISO 13485 - ISO Saudi Arabia","isPartOf":{"@id":"https:\/\/www.iso-saudi.net\/blog\/#website"},"datePublished":"2019-11-13T06:26:52+00:00","breadcrumb":{"@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.iso-saudi.net\/blog\/general-qms-requirements-for-iso-13485\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.iso-saudi.net\/blog\/"},{"@type":"ListItem","position":2,"name":"General QMS Requirements For ISO 13485"}]},{"@type":"WebSite","@id":"https:\/\/www.iso-saudi.net\/blog\/#website","url":"https:\/\/www.iso-saudi.net\/blog\/","name":"ISO Saudi Arabia","description":"ISO Saudi Arabia","publisher":{"@id":"https:\/\/www.iso-saudi.net\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.iso-saudi.net\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.iso-saudi.net\/blog\/#organization","name":"ISO Saudi Arabia","url":"https:\/\/www.iso-saudi.net\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.iso-saudi.net\/blog\/wp-content\/uploads\/2019\/11\/logo-1.png","contentUrl":"https:\/\/www.iso-saudi.net\/blog\/wp-content\/uploads\/2019\/11\/logo-1.png","width":181,"height":38,"caption":"ISO Saudi Arabia"},"image":{"@id":"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.iso-saudi.net\/blog\/#\/schema\/person\/d8b33624737a3c0e53b36522a4f404fd","name":"admin","sameAs":["http:\/\/9558030567f6cd9afb9be1c2f5fc56bf"],"url":"https:\/\/www.iso-saudi.net\/blog\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/posts\/847","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/comments?post=847"}],"version-history":[{"count":1,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/posts\/847\/revisions"}],"predecessor-version":[{"id":848,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/posts\/847\/revisions\/848"}],"wp:attachment":[{"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/media?parent=847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/categories?post=847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iso-saudi.net\/blog\/wp-json\/wp\/v2\/tags?post=847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}