{"id":3755,"date":"2021-03-31T13:00:35","date_gmt":"2021-03-31T12:00:35","guid":{"rendered":"https:\/\/www.imsm.com\/au\/news\/how-to-get-iso-13485-certification\/"},"modified":"2021-05-27T12:26:47","modified_gmt":"2021-05-27T11:26:47","slug":"how-to-get-iso-13485-certification","status":"publish","type":"post","link":"https:\/\/www.imsm.com\/au\/news\/how-to-get-iso-13485-certification\/","title":{"rendered":"How to get ISO 13485 certification"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">If you\u2019re a medical device manufacturer, it\u2019s likely that ISO 13485 will be on your radar. This internationally-recognised standard ensures such vital technology as yours is safe, effective and delivered to a high quality. Not only does the certification help you become compliant with national and international legal requirements, but it will also help <\/span><span style=\"font-weight: 400;\">to<\/span><span style=\"font-weight: 400;\"> open your business to a global market. Here\u2019s how to become ISO 13485 certified.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What is ISO 13485?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ISO 13485 is a type of Quality Management System (QMS) for organisations that<\/span> <span style=\"font-weight: 400;\">provide medical devices. Anyone in the industry knows that your product needs to consistently meet client and regulatory requirements &#8211; <\/span><span style=\"font-weight: 400;\">a service that has become even more vital in the wake of the global coronavirus pandemic<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ISO 13485 is the most accepted global standard of its kind and comes with a wealth of advantages. The benefits of ISO 13845 include:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Getting up-to-date with the needs of regulatory authorities<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Confidence to establish your business in the global market<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Establishing robust control processes, including product development, manufacture and distribution<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Optimised efficiency which leads to minimised costs<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Gaining control of your supply chain<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">Is ISO 13485 mandatory?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">In a nutshell, no, ISO 13485 is not mandatory, however, certification is extremely important as it harmonises your practices with legal and regulatory requirements that exist across the country, the EU and the rest of the globe. While not mandatory, an organisation may find difficulty operating in some markets or getting their product recognised without it. Like most ISO standards, the framework is flexible<\/span><span style=\"font-weight: 400;\">,<\/span><span style=\"font-weight: 400;\"> and you can build a QMS for medical devices that suit your organisation as long as it meets international standards.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How to get ISO 13485 certification?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Many medical device manufacturers find that expert consultants can help them implement their ISO 13485 QMS with ease. With IMSM, our consultants work with you to design your QMS and design control requirements, before submitting your organisation to a recognised certification body to audit your business and get you ISO 13485 certified.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ISO 13485 requirements are applicable to any organisation, no matter the size or complexity, including services as well as products. The structure of the standard consists of eight sections: the first three are introductory, and the final five contain details of the requirements for compliance for medical device manufacturing. The five main sections are as follows:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Section 4: Quality Management System &#8211; discussing the QMS and documentation requirements<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Section 5: Management Responsibility &#8211; outlining how management is responsible for the success and maintenance of the QMS<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Section 6: Resource Management &#8211; detailing how human resources, buildings, infrastructure and the working environment need to be controlled<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Section 7: Product Realisation &#8211; dealing with how to plan, review, design, purchase, create, control and measure your product<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Section 8: Measurement, Analysis and Improvement &#8211; covering how to monitor your QMS\u2019 success, taking into account essential measurements like customer satisfaction, internal audits and corrective and preventive actions.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The next step involves operating your newly-implemented QMS so you can collect the necessary documentation to audit, review your system and receive certification. These steps are as follows:<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">Performing an internal audit to ensure all the necessary processes are in place and identify any weaknesses that could cost you certification<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Management conduct a formal review to evaluate decision-making and resource assignment<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Use the above tasks to identify problems, correct them and document how they were resolved<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">If you want to know about ISO 13485 and the certification process, <a href=\"https:\/\/www.imsm.com\/au\/iso-13485\/\">click this link!<\/a><\/span><\/p>\n<p><!-- end HubSpot Call-to-Action Code --><\/p>\n<p><!--HubSpot Call-to-Action Code --><span id=\"hs-cta-wrapper-f2c3b4d1-44ce-4f84-8f88-a901f5751daf\" class=\"hs-cta-wrapper\"><span id=\"hs-cta-f2c3b4d1-44ce-4f84-8f88-a901f5751daf\" class=\"hs-cta-node hs-cta-f2c3b4d1-44ce-4f84-8f88-a901f5751daf\"><!-- [if lte IE 8]>\n\n\n<div id=\"hs-cta-ie-element\"><\/div>\n\n\n<![endif]--><a href=\"https:\/\/cta-redirect.hubspot.com\/cta\/redirect\/3038466\/f2c3b4d1-44ce-4f84-8f88-a901f5751daf\" target=\"_blank\" rel=\"noopener noreferrer\"><img loading=\"lazy\" decoding=\"async\" id=\"hs-cta-img-f2c3b4d1-44ce-4f84-8f88-a901f5751daf\" class=\"hs-cta-img\" style=\"border-width: 0px;\" src=\"https:\/\/no-cache.hubspot.com\/cta\/default\/3038466\/f2c3b4d1-44ce-4f84-8f88-a901f5751daf.png\" alt=\"Medical guide\" width=\"820\" height=\"312\" \/><\/a><\/span><script charset=\"utf-8\" src=\"https:\/\/js.hscta.net\/cta\/current.js\"><\/script><script type=\"text\/javascript\"> hbspt.cta.load(3038466, 'f2c3b4d1-44ce-4f84-8f88-a901f5751daf', {\"region\":\"na1\"}); <\/script><\/span><!-- end HubSpot Call-to-Action Code --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you\u2019re a medical device manufacturer, it\u2019s likely that ISO 13485 will be on your radar. This internationally-recognised standard ensures [&hellip;]<\/p>\n","protected":false},"author":25,"featured_media":4372,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","inline_featured_image":false,"pgc_sgb_lightbox_settings":"","footnotes":""},"categories":[5],"tags":[],"class_list":["post-3755","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to get ISO 13485 certification - IMSM AU<\/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.imsm.com\/au\/news\/how-to-get-iso-13485-certification\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to get ISO 13485 certification - IMSM AU\" \/>\n<meta property=\"og:description\" content=\"If you\u2019re a medical device manufacturer, it\u2019s likely that ISO 13485 will be on your radar. 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