{"id":15968,"date":"2022-02-03T18:23:43","date_gmt":"2022-02-03T16:23:43","guid":{"rendered":"https:\/\/qualityacademy.org\/?page_id=15968"},"modified":"2024-05-31T14:59:58","modified_gmt":"2024-05-31T10:59:58","slug":"iso-13485-certification","status":"publish","type":"page","link":"https:\/\/qualityacademy.org\/certifications\/iso-13485-certification\/","title":{"rendered":"ISO 13485 Certification"},"content":{"rendered":"\n<h1>\n\t\tISO 13485 Certification\n\t<\/h1>\n<h2>\n\t\tISO 13485 &#8211; Medical Devices Management Systems Certification\n\t<\/h2>\n\t<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" src=\"https:\/\/i0.wp.com\/qualityacademy.org\/wp-content\/uploads\/2024\/05\/Asset-81-150x150.png?resize=130%2C130&#038;ssl=1\" alt=\"ISO 13485 Certification Badge Transparent\" width=\"130\" height=\"130\" \/><\/p>\n<p>ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.<\/p>\n<p>Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.<\/p>\n\n<h4>Benefits of ISO 13485 certification to your company:<\/h4>\n<ul>\n<li>Global Recognition<\/li>\n<li>Improved legal and regulatory or contractual requirements compliance<\/li>\n<li>ISO 13485 \u00a0Medical Devices Quality Management System (QMS) is very close to the Food and Drug Administration&#8217;s (FDA) QSR standards.<\/li>\n<li>Assistance in monitoring supply chain effectiveness<\/li>\n<li>Increased profit margins<\/li>\n<li>Improved product safety<\/li>\n<li>Increased Efficiency<\/li>\n<li>Proactive error detection and prevention<\/li>\n<li>Cost Savings<\/li>\n<li>More Effective Risk Management<\/li>\n<li>Increased likelihood of meeting Customer Requirements<\/li>\n<\/ul>\n<h4>Benefits of ISO 13485 certification to your customers:<\/h4>\n<ul>\n<li>Quality ensured medical devices<\/li>\n<li>Safe and effective medical devices<\/li>\n<li>Lower skepticism and increased confidence for end-customer<\/li>\n<li>Boost of \u00a0loyal customers and potential customers<\/li>\n<li>Increased profit margins<\/li>\n<\/ul>\n<p>ISO 13485 certification (also known as &#8220;registration&#8221;) is a third-party audit performed by a certification body such as QA who, upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate. This certification is then maintained through regularly scheduled annual surveillance audits by the registrar, with re-certification of the Medical Devices Quality Management System performed on a tri-annual basis.<\/p>\n\t\t\t<a href=\"https:\/\/qualityacademy.org\/certifications\/certification-quotation\/\" target=\"_blank\" rel=\"noopener\">\n\t\t\t\t\t\t\tStart your audit and certification process with us by getting a Free Quote !\n\t\t\t\t\t<\/a>\n\t\n<h3><strong>STEPS OF CERTIFICATION<\/strong><\/h3>\n<blockquote><p><strong>STEP ONE<\/strong><\/p><\/blockquote>\n<p>Complete a <a href=\"https:\/\/qualityacademy.org\/certifications\/certification-quotation\/\" target=\"_blank\" rel=\"noopener\">Quote Request Form<\/a> so that we can understand your company and requirements. We will use this information to accurately define your scope of assessment and provide you with a proposal for certification.<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>STEP TWO<\/strong><\/p><\/blockquote>\n<p>Once you&#8217;ve agreed your proposal, we will contact you to book your assessment with an QA Assessor. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>STEP THREE<\/strong><\/p><\/blockquote>\n<p>Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by QA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.<\/p>\n\n","protected":false},"excerpt":{"rendered":"<p>ISO 13485 Certification ISO 13485 &#8211; Medical Devices Management Systems Certification ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Organizations involved in medical device&#8230;<\/p>\n","protected":false},"author":165716268,"featured_media":0,"parent":15948,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"jetpack_post_was_ever_published":false,"footnotes":""},"class_list":["post-15968","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.6 (Yoast SEO v26.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ISO 13485 Certification - Quality Academy\u00ae<\/title>\n<meta name=\"description\" content=\"ISO 13485 Medical Devices Management Systems Certification\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/qualityacademy.org\/certifications\/iso-13485-certification\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 Certification\" \/>\n<meta property=\"og:description\" content=\"ISO 13485 Medical Devices Management Systems Certification\" \/>\n<meta property=\"og:url\" content=\"https:\/\/qualityacademy.org\/certifications\/iso-13485-certification\/\" \/>\n<meta property=\"og:site_name\" content=\"Quality Academy\u00ae\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/qacert\" \/>\n<meta property=\"article:modified_time\" content=\"2024-05-31T10:59:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/qualityacademy.org\/wp-content\/uploads\/2024\/05\/Asset-81-150x150.png?crop=1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"ISO 13485 Certification\" \/>\n<meta name=\"twitter:description\" content=\"ISO 13485 Medical Devices Management Systems Certification\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/qualityacademy.org\/certifications\/iso-13485-certification\/\",\"url\":\"https:\/\/qualityacademy.org\/certifications\/iso-13485-certification\/\",\"name\":\"ISO 13485 Certification - 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