{"id":4305,"date":"2021-10-21T07:36:36","date_gmt":"2021-10-21T07:36:36","guid":{"rendered":"https:\/\/ias-certification.com\/?p=4305"},"modified":"2024-11-16T11:10:26","modified_gmt":"2024-11-16T11:10:26","slug":"iso-13485-medical-devices","status":"publish","type":"post","link":"https:\/\/ias-certification.com\/ca\/blog\/iso-13485-medical-devices\/","title":{"rendered":"ISO 13485 Medical Devices"},"content":{"rendered":"<div  style='padding-bottom:10px; color:#b02b2c;' class='av-special-heading av-special-heading-h1 custom-color-heading blockquote modern-quote  avia-builder-el-0  el_before_av_hr  avia-builder-el-first  '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >ISO 13485 Medical Devices<\/h1><div class='special-heading-border'><div class='special-heading-inner-border' style='border-color:#b02b2c'><\/div><\/div><\/div>\n<div  style='height:20px' class='hr hr-invisible   avia-builder-el-1  el_after_av_heading  el_before_av_textblock '><span class='hr-inner ' ><span class='hr-inner-style'><\/span><\/span><\/div>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '  style='font-size:14px; '  itemprop=\"text\" ><h2 style=\"text-align: justify;\"><span style=\"color: #b02b2c;\"><strong>About ISO 13485 Medical Devices<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">ISO 13485 is a set of international standards for manufacturers and certifiers of medical devices. &#8216;ISO 13485 Medical Devices&#8217; means that the medical devices follow all guidelines under ISO 13485 standards. ISO 13485:2016 specifies the requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices that meet the regulatory requirements applicable to the device and, if applicable, patient safety goals.\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"aligncenter wp-image-5648 lazyload\" title=\"ISO 13485 Medical Devices\" data-src=\"https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-300x200.jpg\" alt=\"ISO 13485 Medical Devices\" width=\"329\" height=\"219\" data-srcset=\"https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-300x200.jpg 300w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-1030x687.jpg 1030w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-768x512.jpg 768w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-1536x1024.jpg 1536w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-2048x1365.jpg 2048w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-1500x1000.jpg 1500w, https:\/\/ias-certification.com\/ca\/wp-content\/uploads\/2024\/11\/ISO-13485-Certification-705x470.jpg 705w\" data-sizes=\"(max-width: 329px) 100vw, 329px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 329px; --smush-placeholder-aspect-ratio: 329\/219;\" \/><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #b02b2c;\">ISO 13485:2016 Version<\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">The most recent revision of ISO 13485 was published in March 2016. ISO 13485:2016 is a major update from ISO 13485:2003. ISO published ISO 13485:2016 to incorporate changes in regulation and technology, improve clarity, alignment with ISO 9001, and other standards requirements.\u00a0<\/span><\/p>\n<h3 style=\"text-align: left;\"><span style=\"color: #b02b2c;\">What is a Medical Device?<\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">ISO 13485 defines a &#8220;medical device&#8221; as an instrument, apparatus, appliance, software, material, or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease. Examples of medical devices under the ISO 13485 standard are:\u00a0<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Spectacle lenses for correcting defective vision<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Pacemakers<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Dialysis machines\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Bone plates and screws for fractures\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Intravenous infusion pumps\u00a0<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: left;\"><span style=\"color: #b02b2c;\">What is ISO 13485 Certification?<\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\"><span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/blog\/iso-13485-medical-devices\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">&#8216;ISO 13485 Medical Devices<\/span><\/a><\/strong><\/span>&#8216; certification is a process of verifying the conformity of your organization&#8217;s medical device to ISO 13485 standards. ISO certification is required by many regulators in response to ISO 13485 Medical Devices Directive. <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/iso-certification-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO Certification<\/span><\/a><\/strong><\/span> helps you ensure that your medical devices meet high-quality requirements and are safe for customers.\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">You will need to operate the QMS for a period of time once all of the processes and procedures are in place. You will be able to gather the records you need to move on to the next steps, which include an audit and review of your system, as well as certification. To achieve successful certification, your business should do the following steps after completing all of your documentation and executing it:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">Internal audit<\/span><\/strong> &#8211; The internal audit is in place to ensure that your QMS procedures are in good working order. The purpose is to guarantee that records are kept in order to certify process compliance and to identify flaws and vulnerabilities that would otherwise go unnoticed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">Management review<\/span><\/strong> &#8211; A formal evaluation of the key facts about the management system processes by your management in order to make appropriate decisions and assign resources.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">Corrective actions<\/span> <\/strong>\u2014 After the internal audit and management review, you must address the root cause of any problems that were discovered and document how they were remedied.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">There are two stages to the &#8216;<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/certification-process-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO 13485 medical devices&#8217; certification process<\/span><\/a><\/strong><\/span> conducted by a certification body:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">Stage One (preliminary audit)<\/span><\/strong>: Your chosen certification body&#8217;s auditors will verify to see if your documentation complies with ISO 13485 guidelines and conduct a preliminary audit to verify the QMS is properly implemented.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">Stage Two (implementation audit)<\/span><\/strong> &#8211; The certification body auditors will analyze paperwork, records, and company practices to see if your real actions are compliant with both ISO 13485 and your own documentation. Any non-conformities found in the initial stage 1 audit will be checked to see if they have been resolved. ISO 13485 medical devices certification will be issued once your organization successfully completes the stage 2 audit.<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: left;\"><span style=\"color: #b02b2c;\">ISO 13485 Training<\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">The <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/iso-13485-training-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO 13485 training<\/span><\/a><\/strong><\/span> courses available will provide you with all of the information you need to understand ISO 13485, get started on your ISO QMS, and complete ISO certification audits. ISO 13485 is a complex standard that can be difficult to implement if you don&#8217;t know what it&#8217;s asking of you. This ISO 13485 training is available to help you learn more about ISO 13485 without having to read through numerous books and study guides.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\">The ISO 13485 training courses are also beneficial because they provide you with a certification upon successfully completing the course, which shows your employers that you have what it takes to succeed in ISO medical devices quality management system auditing. The following are a list of ISO 13485 training offered:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">ISO 13485 Lead Auditor Course<\/span> <\/strong>\u2013 This is a five-day training course aimed at helping participants comprehend the ISO 13485 QMS standard and how to apply it to auditing management systems against these standards. The course includes an exam at the conclusion to check knowledge and competence, and an individual can only become approved to audit for a certifying organization after completing an accredited course.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">ISO 13485 Internal Auditor Training<\/span> <\/strong>\u2014 This is a two-day course that is based on the lead auditor course above, but it does not go into detail on how to conduct external third-party audits. Therefore, it is best for someone who is just starting out doing internal audits within a company.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\"><strong><span style=\"color: #b02b2c;\">ISO 13485 Awareness and Implementation Courses<\/span><\/strong> &#8211; These courses give you general information about ISO 13485 and how to put them into practice. These courses can be one or two days long and are important for all employees who implement a QMS within their organizations.<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: left;\"><span style=\"color: #b02b2c;\">Benefits of ISO 13485 Certification<\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000;\"><span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/iso-13485-certification-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO 13485 certification<\/span><\/a><\/strong><\/span> is beneficial because it shows the world that your organization&#8217;s products are produced in accordance with <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/iso-training-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO standards<\/span><\/a><\/strong><\/span>, which helps you win more global business opportunities. ISO also has a great reputation for excellence and professionalism when it comes to certifying manufacturing companies all over the world. The following are just some of the benefits of ISO 13485 certification:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Make new business contacts.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Obtain a competitive edge<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Increase efficiency while lowering expenses<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Provide medical equipment that is both safer and more efficient.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Empowered and more knowledgeable employees<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; color: #000000;\">Increase in customer satisfaction, leading to customer retention<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\"><span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/contact-us\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">Contact IAS<\/span><\/a><\/strong><\/span> today to learn more about <span style=\"font-weight: 400; color: #000000;\">ISO 13485 medical devices<\/span>, or visit our <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ias-certification.com\/ca\/frequently-asked-question-in-canada\/\"><span style=\"color: #b02b2c; text-decoration: underline;\">ISO 13485 medical devices frequently asked questions<\/span><\/a><\/strong><\/span> page!<\/span><\/p>\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":5648,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4305","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/posts\/4305","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/comments?post=4305"}],"version-history":[{"count":6,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/posts\/4305\/revisions"}],"predecessor-version":[{"id":5693,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/posts\/4305\/revisions\/5693"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/media\/5648"}],"wp:attachment":[{"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/media?parent=4305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/categories?post=4305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ias-certification.com\/ca\/wp-json\/wp\/v2\/tags?post=4305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}