ISO 13485 - Quality Management for Medical Devices

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</ul> </div> </nav> <div> </div> </div> </div> <script> $(document).ready(function () { if (screen.width <= 900) { $('.bsi-single-hero .bsi-hero-image').remove(); } else { $('.bsi-single-hero .bsi-hero-image-small').remove(); } }); </script></div></div></div> <div class="l-grid"> <div class="l-grid-4"> <div><div> <div id="466274"> <div class="bsi-grid-wrapper bsi-intro-content bg-normal default-padding" id="A_466274"> <div class="page-intro intro-content-container bsi-grid normal"> <h2 class="teaser-block-title bsi-grid-9">Introduction to a medical device QMS</h2> <div class="body-copy bsi-grid-9 ic-content"> <div> <p>Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.</p> </div> </div> </div> </div> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="882737"> <section class="teaser-block bcp cp-white-bg" id="A_882737"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 no-style clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container content-promo-content"> <div class="cpblock-content content-para"><div class="youtube-responsive-container"><iframe src="https://www.youtube.com/embed/P-gaD4B6bCE" width="100%" height="415"></iframe></div></div> <div class="content-promo-buttons"> <div class="more large-vp"> <div class="cpblock-button-red content-promo-button"><a href="/globalassets/meddev/localfiles/en-gb/services/bsi-md-iso-13485-qms-brochure-uk-en.pdf" target="_blank" title="Download our ISO 13485 brochure">Download our ISO 13485 brochure</a></div> </div> </div> </div> </div> </article> </div> </section> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="838"> <section class="teaser-block bcp cp-white-bg" id="A_838"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 no-style clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container content-promo-content"> <h2 class="teaser-title cpblock-title cp-title-style">What is ISO 13485?</h2> <div class="cpblock-content content-para"><p>EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.</p> <p>Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in.</p> <p>ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. Therefore, ISO 13485 includes particular requirements for organisations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. This makes it more prescriptive in nature and requires a more thoroughly documented QMS.</p></div> <div class="content-promo-buttons"> </div> </div> </div> </article> </div> </section> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="898302"> <section class="teaser-block bcp cp-white-bg" id="A_898302"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 teal-top clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-image"> <img src="/globalassets/meddev/localfiles/en-gb/images/160x130/mdr-qms-deadline-160-130.jpg" class="thumb" alt="MDR QMS deadline 2023" width="160" height="130" title="MDR QMS deadline 2023" /> </div> <div class="cpblock-content-container content-promo-content"> <div class="cpblock-content content-para"></div> <div class="content-promo-buttons"> <div class="more large-vp second-cta"> <div class="cpblock-button-white content-promo-button"><a href="/globalassets/meddev/localfiles/en-gb/documents/bsi-md-mdr-application-deadline-en-gb.pdf" target="_blank" title="Download the transition guidance">Download the transition guidance</a></div> </div> </div> </div> </div> </article> </div> </section> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="840"> <section class="teaser-block bcp cp-white-bg" id="A_840"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 no-style clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container content-promo-content"> <h2 class="teaser-title cpblock-title cp-title-style">What are the benefits of being certified to ISO 13485?</h2> <div class="cpblock-content content-para"><p>ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.</p> <p>When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, so ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.</p> <p>The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.</p> <p>It can also help to minimise any surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.</p> <p>An ISO 13485 certification gives both suppliers and service providers the opportunity to greatly enhance an organisation's marketability as more and more manufacturers require certification in order to do business with a vendor.</p></div> <div class="content-promo-buttons"> </div> </div> </div> </article> </div> </section> </div> </div><div> <div class="quote-rhs-block bsi-grid-wrapper"> <aside class="panel light quote-rhs-block-content bsi-grid quote-nbg-dark-teal-left-border" style="border-color:#ECECEC"> <div class="testimonial bsi-grid-9"> <blockquote><p>Successfully certified organizations are able to demonstrate the effective interconnectivity of their processes. It is essential to be able to demonstrate how outputs from complaints, for example, feed into management review, improvement processes, Technical Documentation and risk management updates, to name a few.</p></blockquote> <cite> BILL ENOS, GLOBAL ASSESSMENT DELIVERY DIRECTOR, BSI </cite> </div> </aside> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="944879"> <section class="teaser-block bcp cp-white-bg" id="A_944879"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 grey-top clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-image"> <img src="/globalassets/meddev/localfiles/en-gb/images/160x130/mdr2-160-130.jpg" class="thumb" alt="MDR" width="160" height="130" title="MDR" /> </div> <div class="cpblock-content-container content-promo-content"> <h2 class="teaser-title cpblock-title cp-title-style">ISO 13485 FAQs</h2> <div class="cpblock-content content-para"><p>Find answers to most frequently asked questions on ISO 13485 and associated topics.</p></div> <div class="content-promo-buttons"> <div class="more large-vp"> <div class="cpblock-button-teal content-promo-button"><a href="/globalassets/meddev/localfiles/en-gb/documents/bsi-md-iso-13485-faqs-en-gb.pdf" target="_blank" title="Download FAQs">Download FAQs</a></div> </div> </div> </div> </div> </article> </div> </section> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="562424"> <section class="teaser-block bcp cp-white-bg" id="A_562424"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 no-style clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container content-promo-content"> <h2 class="teaser-title cpblock-title cp-title-style">ISO 13485 and Product Certification</h2> <div class="cpblock-content content-para"><p>ISO 13485 is the internationally accepted standard a medical device organisation can implement to demonstrate compliance with MedTech legislations.</p> <p>Obtaining an ISO 13485 Certification with BSI ensures worldwide recognition for your organisation compliance with ISO 13485 requirements.</p> <p>It also represents a solid starting point if you are thinking of applying for <a title="MDR" href="/zh-TW/medical-devices/Our-services/mdr-revision/" target="_top">MDR</a>, <a title="IVDR" href="/zh-TW/medical-devices/Our-services/ivdr-revision/" target="_top">IVDR</a> or <a title="UK MDR" href="/zh-TW/medical-devices/market-access/ukca-market-access/" target="_top">UK MDR</a>:</p> <ul> <li>European Regulations: (MDR) (EU) 2017/745 and (IVDR)(EU) 2017/746</li> <li>UK Regulation: UK MDR 2002</li> </ul></div> <div class="content-promo-buttons"> </div> </div> </div> </article> </div> </section> </div> </div><div> <div id="882358"> <div class="l-grid bsi-grid-wrpper two-column-fifty-fifty tw-white-bg ff-default-top-padding ff-default-bottom-padding" id="A_882358"> <div class="l-grid-4 bsi-grid"> <section class="teaser-block srvc-teaser-block shpe-theme"> <div class="l-grid"> <div class="l-grid-2 bsi-grid-6"> <div><div> <div id="882362"> <div class="l-grid"> <section class="bsi-grid scale-container" id="A_882362"> <div class="full-bleed-content-container"> <div class="full-bleed-content-image" style="background:url(/globalassets/meddev/localfiles/en-gb/images/560x345/ce-marking-560-345.jpg)"> <img src="/globalassets/meddev/localfiles/en-gb/images/375x275/ce-marking-375-275.jpg" alt="/globalassets/meddev/localfiles/en-gb/images/375x275/ce-marking-375-275.jpg" width="375" height="275" /> </div> <div class="full-bleed-content-container-content"> <div class="block-links"> <div class="find-more"> <a class="arrow" href="/zh-TW/medical-devices/Our-services/ce-marking/" target="_top" title="Find out more about CE marking "> <span>Find out more about CE marking </span><label></label> </a> </div> </div> </div> </div> </section> </div> </div> </div></div> </div> <div class="l-grid-2 bsi-grid-6"> <div><div> <div id="882363"> <div class="l-grid"> <section class="bsi-grid scale-container" id="A_882363"> <div class="full-bleed-content-container"> <div class="full-bleed-content-image" style="background:url(/globalassets/meddev/localfiles/en-gb/images/560x345/ukca-marking-560-345.jpg)"> <img src="/globalassets/meddev/localfiles/en-gb/images/375x275/ukca-marking-375-275.jpg" alt="/globalassets/meddev/localfiles/en-gb/images/375x275/ukca-marking-375-275.jpg" width="375" height="275" /> </div> <div class="full-bleed-content-container-content"> <div class="block-links"> <div class="find-more"> <a class="arrow" href="/zh-TW/medical-devices/market-access/ukca-market-access/" target="_top" title="Find out more about UKCA marking "> <span>Find out more about UKCA marking </span><label></label> </a> </div> </div> </div> </div> </section> </div> </div> </div></div> </div> </div> </section> </div> </div> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="847"> <section class="teaser-block bcp cp-white-bg" id="A_847"> <div class="bsi-grid clearfix"> <article class="teaser block-links cpblock bsi-grid-9 no-style clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container content-promo-content"> <h2 class="teaser-title cpblock-title cp-title-style">BSI's approach to excellence</h2> <div class="cpblock-content content-para"><p>BSI has a very selective recruitment process for the professionals we hire to conduct ISO 13485 audits.</p> <p>Candidates must have suitable qualifications and sufficient background and knowledge of medical devices design, manufacturing and application of the device technology.</p> <p>Our assessment staff come to BSI with exceptional real industry experience. They then go through rigorous internal training and BSI qualification processes including best practice quality systems auditing techniques, understanding critical manufacturing processes and interpretation of regulatory compliance expectations.</p> <p>BSI auditors are experts in current state-of-the-art technology and are constantly trained on new requirements and expected future changes. BSI is always looking ahead to ensure that our clients are well informed of future changes to compliance and the regulatory landscape.</p></div> <div class="content-promo-buttons"> </div> </div> </div> </article> </div> </section> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="A_882310"> <div class="l-grid-4 bsi-grid"> <div class="full-beeld-img-defult full-bleed-right-top" style="background:url(/globalassets/meddev/localfiles/en-gb/images/1400x600/training-1400-600.jpg)"> <div class="ltr"> <div class="card-bleed bsi-grid"> <img src="/globalassets/meddev/localfiles/en-gb/images/375x275/training1-375-275.jpg" alt="QMS training" width="375" height="275"> <div class="full-bleed-content no-quote"> <div class="full-bleed-content-width"> <div class="full-bleed-content-title"> <h2 class="teaser-block-title"> Training courses </h2> </div> <div class="full-bleed-intro"><p>We offer training courses tailored to ISO 13485:2016 to help support and grow your business.</p></div> <ul> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/introduction-to-iso-13485-medical-devices/" target="_blank" title="ISO 13485:2016 Introduction">ISO 13485:2016 Introduction<label></label></a> </li> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/iso-13485-requirements-training-course-on-demand-elearning/" target="_blank" title="ISO 13485:2016 Requirements On-demand eLearning">ISO 13485:2016 Requirements On-demand eLearning<label></label></a> </li> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/ISO-13485-Clause-by-Clause/" target="_blank" title="ISO 13485:2016 Clause by Clause">ISO 13485:2016 Clause by Clause<label></label></a> </li> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/implementing-ISO-13485/" target="_blank" title="Implementing ISO 13485:2016">Implementing ISO 13485:2016<label></label></a> </li> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/iso-13485-internal-auditor/" target="_blank" title="Internal Auditor ISO 13485:2016">Internal Auditor ISO 13485:2016<label></label></a> </li> <li> <a class="arrow" href="/zh-TW/medical-devices/ISO-13485-training-courses/quality-management-for-medical-devices-auditor-lead-auditor-course/" target="_blank" title="Lead Auditor ISO 13485:2016">Lead Auditor ISO 13485:2016<label></label></a> </li> </ul> <div class="bleed-button-Teal"><a href="/zh-TW/medical-devices/ISO-13485-training-courses/" target="_top" title="View all training"><span>View all training</span></a></div> </div> </div> </div> </div> </div> </div> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div class="1-grid panel-frame-white panel-main panel-frame-title" id="A_882510"> <div class="l-grid-4 bsi-grid-wrapper bsi-grid-lable"> <section class="bsi-grid box-container"> <div class="inner-multi panel-frame-title"> <div class="tire-grid-box multi"> <h2 class="teaser-block-title panel-frame-title"> ISO 13485 resources to support you </h2> <div class="box-content clearfix"> <div class="child-roc"> <div><div> <div id="882513"> <a href="/zh-TW/medical-devices/Our-services/Medical-Device-Single-Audit-Program/" target="_top" title="MDSAP"> <div class="bsi-grid-lable"> <div class="desktop-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="MDSAP" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/375x350/mdsap-350-350.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>Medical Device Single Audit Program</h3> <div class="white"> <div class="arrow">For manufacturers wishing to sell their products across multiple global markets.<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Find out more</h4> </div> </div> </div> <div class="mobile-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="MDSAP" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/320x320/mdsap-new-320-320.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>Medical Device Single Audit Program</h3> <div class="white"> <div class="arrow" >For manufacturers wishing to sell their products across multiple global markets.<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Find out more</h4> </div> </div> </div> </div> </a> </div> </div></div> </div> <div class="child-roc"> <div><div> <div id="882514"> <a href="/globalassets/meddev/localfiles/en-gb/documents/bsi-md-trauson-13485training-case-study-en-gb.pdf" target="_blank" title="ISO 13485 Case Study"> <div class="bsi-grid-lable"> <div class="desktop-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="ISO 13485 Case Study" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/375x350/iso-13485-trauson-375-350.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>ISO 13485 Case Study</h3> <div class="white"> <div class="arrow">Find out how ISO 13485:2016 had a positive impact on Trauson and their business.<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Download case study</h4> </div> </div> </div> <div class="mobile-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="ISO 13485 Case Study" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/320x320/iso-13485-trauson-320-320.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>ISO 13485 Case Study</h3> <div class="white"> <div class="arrow" >Find out how ISO 13485:2016 had a positive impact on Trauson and their business.<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Download case study</h4> </div> </div> </div> </div> </a> </div> </div></div> </div> <div class="child-roc"> <div><div> <div id="882517"> <a href="/en-GB/medical-devices/news-centre/enews/2021-news/iso-13485-following-brexit/" target="_top" title="ISO 13485 after brexit"> <div class="bsi-grid-lable"> <div class="desktop-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="ISO 13485 after brexit" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/375x350/iso-13485-brexit-375-350.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>ISO 13485 after brexit </h3> <div class="white"> <div class="arrow">Find out more about ISO 13485 following Brexit and the validity of QMS certificates<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Read the article</h4> </div> </div> </div> <div class="mobile-panel-image"> <div class="three-tire-box multi-small-box dark-gradient" title="ISO 13485 after brexit" style="background: linear-gradient( to bottom, rgba(64,64,64,1) 0%, rgba(64,64,64,0) 40%, rgba(64,64,64,0) 75%, rgba(64,64,64,1) 100% ),url(/globalassets/meddev/localfiles/en-gb/images/320x320/iso-13485-brexit-320-320.jpg);background-size:100% 100%!important;"> <div class="top-content white"> <h3>ISO 13485 after brexit </h3> <div class="white"> <div class="arrow" >Find out more about ISO 13485 following Brexit and the validity of QMS certificates<label></label></div> </div> </div> <div class="bottom-content white"> <h4>Read the article</h4> </div> </div> </div> </div> </a> </div> </div></div> </div> </div> </div> </div> </section> </div> </div> </div><div> <div style="margin: 30px 0;"> <hr class="divColor bsi-grid" /> </div> </div><div> <div id="A_431253"> <section class="teaser-block bcpwb" id="431253"> <div class="bsi-grid clearfix"> <aside class="panel block-links cpblock bsi-grid-9 teal-top clearfix"> <div class="cpblock-container clearfix"> <div class="cpblock-content-container"> <h2 class="panel-title cpblock-title">Get in touch</h2> <div class="cpblock-content"><p>Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process.</p> <p>Email us at <a title="medicaldevices@bsigroup.com" href="mailto:MedicalDevices@bsigroup.com" target="_blank" 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