ISO 13485:2016 - Medical devices — Quality management systems

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It can also benefit suppliers and external parties that provide product, including quality management system-related services to such organizations." } },{ "@type": "Question", "name": "How does ISO 13485 differ from ISO 9001?", "acceptedAnswer": { "@type": "Answer", "text": "While ISO 9001 applies to a wide range of industries, ISO 13485 is specifically tailored to the regulatory and safety requirements of the medical device industry. 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Therefore this version remains current.</div> </div> </div> </div> </div> <div class="col-md-4 col-md-offset-1"> <div class="card store-box buy-box buybox" id="cs59752"> <div class="card-header text-center"><h4>ISO 13485:2016</h4></div> <div class="card-body"> <span class="visually-hidden" id="indexReference_cs59752" data-index="59752 - ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes"></span> <span class="visually-hidden" id="itemReference_cs59752">ISO 13485:2016</span> <div class="visually-hidden" id="csNumber_cs59752">59752</div> <form class="box-option" id="form_cs59752"> <div class="mb-3"> <div class="section-head mb-1 text-sm"> Language</div> <div class="form-group"> <select class="form-select form-select-sm bkilang" id="bkilang_cs59752"> <option value="en" selected>English</option> <option value="fr" >French</option> </select> </div> </div> <div class="section-head mb-1 text-sm"> Format</div> <div class="formats formats_cs59752" id="bkifmt_cs59752_en" style="display: none;"><div class="form-check text-sm" id="bkifmt_cs59752_en_1"> <input class="form-check-input" data-type="std" data-price="177" checked="checked" type="radio" name="format_en" id="format_cs59752_en_1" value="01ub000000288PaAAI~a05b0000005WV37AAG~a0fb0000000eNDkAAM~a0cb0000009Xfg9AAC"/> <label class="form-check-label" for="format_cs59752_en_1">PDF + ePub</label> </div><div class="form-check text-sm" id="bkifmt_cs59752_en_2"> <input class="form-check-input" data-type="std" data-price="212" type="radio" name="format_en" id="format_cs59752_en_2" value="01ub000000288PaAAI~a05b0000007CTjMAAW~a0fb000000940EgAAI~a0cb0000009Xu7JAAS"/> <label class="form-check-label" for="format_cs59752_en_2">PDF + ePub + Redline</label> </div><div class="form-check text-sm" id="bkifmt_cs59752_en_3"> <input class="form-check-input" data-type="std" data-price="177" type="radio" name="format_en" id="format_cs59752_en_3" value="01ub000000288PaAAI~a05b0000005WV3CAAW~a0fb0000000eNECAA2~a0cb0000004vLhyAAE"/> <label class="form-check-label" for="format_cs59752_en_3">Paper</label> </div></div><div class="formats formats_cs59752" id="bkifmt_cs59752_fr" style="display: none;"><div class="form-check text-sm" id="bkifmt_cs59752_fr_1"> <input class="form-check-input" data-type="std" data-price="177" checked="checked" type="radio" name="format_fr" id="format_cs59752_fr_1" value="01ub000000288PaAAI~a05b0000005WV37AAG~a0fb0000000eNEOAA2~a0cb0000009XffNAAS"/> <label class="form-check-label" for="format_cs59752_fr_1">PDF + ePub</label> </div><div class="form-check text-sm" id="bkifmt_cs59752_fr_2"> <input class="form-check-input" data-type="std" data-price="177" type="radio" name="format_fr" id="format_cs59752_fr_2" value="01ub000000288PaAAI~a05b0000005WV3CAAW~a0fb0000000eNENAA2~a0cb0000004vLgVAAU"/> <label class="form-check-label" for="format_cs59752_fr_2">Paper</label> </div></div></form> <div class="align-items-baseline box-price" itemprop="offers" itemscope itemtype="https://schema.org/Offer"> <div class="d-flex justify-content-center align-items-baseline gap-2"> <link itemprop="url" href="https://www.iso.org:-1/standard/59752.html" /> <meta itemprop="availability" content="https://schema.org/InStock" /> <span class="currency"><abbr title="Swiss francs" itemprop="priceCurrency">CHF</abbr></span> <span class="price d-flex align-items-baseline gap-2"> <span class="amount" id="productPrice_cs59752" itemprop="price">177</span> </span> </div> </div> <div class="d-grid orderBasket box-action pb-0"> <button id="add_cs59752" class="btn btn-primary" data-bs-toggle="modal" data-bs-target="#iso-optout" onclick="javascript:addToBasket('cs59752', '1', 'en', 'cs')"> Add to cart</button> </div> </div> <div id="priceConverter" class="smaller text-center p-3">Convert Swiss francs (CHF) to <a id="convertLink_cs59752" target="_blank" href="https://www.xe.com/en/currencyconverter/convert/?Amount=177&From=CHF&To=EUR">your currency</a></div> </div> </div> </div> </div> </section> <svg class="wave" preserveAspectRatio="none" viewBox="0 0 1440 96" fill="none" xmlns="http://www.w3.org/2000/svg"><path d="m0 96 80-5.3C160 85 320 75 480 64s320-21 480-21.3c160 .3 320 10.3 400 16l80 5.3V0H0v96Z"></path></svg> <section id="product-details"> <div class="container"> <div class="row"> <div class="col-md-7"> <h2>What is ISO 13485?</h2> <p>ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations <strong>ensure their medical devices meet both customer and regulatory demands for safety and efficacy.</strong></p> <h2>Why is ISO 13485 important?</h2> <p>ISO 13485 is crucial for manufacturers and suppliers of medical devices as it establishes a framework to ensure consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. It aids in meeting rigorous regulatory requirements and managing risk, while ensuring best practices in the manufacture of medical devices. This standard not only facilitates market access across different countries but also enhances trust among stakeholders through demonstrated commitment to safety and quality.</p><h2>Benefits</h2> <ul class="list-unstyled" id="benefits" role="list"> <li><strong><i class="bi bi-check-circle-fill text-success"></i></strong> <strong>Risk management enhancement</strong>: Provides systematic methods to identify and mitigate risks throughout the product lifecycle, ensuring patient and user safety</li> <li><strong><i class="bi bi-check-circle-fill text-success"></i> Regulatory compliance</strong>: Helps organizations meet strict regulatory requirements specific to medical device manufacturing, crucial for market access and global trade.</li> <li><strong><i class="bi bi-check-circle-fill text-success"></i></strong> <strong>Operational efficiency</strong>: Streamlines processes to improve overall efficiency and effectiveness, reducing waste and increasing productivity</li> <li><strong><i class="bi bi-check-circle-fill text-success"></i> Market access</strong>: Facilitates entry into global markets with standardized compliance, enhancing competitive advantage</li> <li><strong><i class="bi bi-check-circle-fill text-success"></i> Enhanced reputation</strong>: Builds credibility and trust with stakeholders, including regulators, customers, and end-users, through proven adherence to a globally recognized quality standard</li> </ul> <p> </p><h3>FAQ</h3><div class="accordion full-width faqs" id="id-4161109e-dbcb-40ca-a0bf-cb2a9a35f17d"> <div class="accordion-item"> <h3 class="accordion-header" id="heading-e0b02a90-694b-4966-a5dd-fbd636998e74"><button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#id-e0b02a90-694b-4966-a5dd-fbd636998e74" aria-expanded="true" aria-controls="id-e0b02a90-694b-4966-a5dd-fbd636998e74"> Who should use ISO 13485?</button> </h3><div id="id-e0b02a90-694b-4966-a5dd-fbd636998e74" class="accordion-collapse collapse " aria-labelledby="heading-e0b02a90-694b-4966-a5dd-fbd636998e74" data-bs-parent="#id-4161109e-dbcb-40ca-a0bf-cb2a9a35f17d"> <div class="accordion-body"> <p>ISO 13485 is intended for any organization involved in the design, production, installation, and servicing of medical devices and related services. It can also benefit suppliers and external parties that provide product, including quality management system-related services to such organizations.</p> </div> </div> </div><div class="accordion-item"> <h3 class="accordion-header" id="heading-2cfd6fbb-0176-4b4d-9645-833baa8d7543"><button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#id-2cfd6fbb-0176-4b4d-9645-833baa8d7543" aria-expanded="true" aria-controls="id-2cfd6fbb-0176-4b4d-9645-833baa8d7543"> How does ISO 13485 differ from ISO 9001?</button> </h3><div id="id-2cfd6fbb-0176-4b4d-9645-833baa8d7543" class="accordion-collapse collapse " aria-labelledby="heading-2cfd6fbb-0176-4b4d-9645-833baa8d7543" data-bs-parent="#id-4161109e-dbcb-40ca-a0bf-cb2a9a35f17d"> <div class="accordion-body"> <p>While ISO 9001 applies to a wide range of industries, <strong>ISO 13485 is specifically tailored to the regulatory and safety requirements of the medical device industry</strong>. It emphasizes meeting regulatory as well as customer requirements, risk management, and effective process validation more than ISO 9001.</p> </div> </div> </div></div></div> <div class="col-md-4 col-md-offset-1"> <h3>Buy together</h3> <div class="card"> <div class="card-body"><span class="badge badge-card rounded-pill bg-dark"><i class="bi-box-regular me-2"></i><strong>Bundle</strong><span class="text-warning"> - 10% discount</span></span> <h5 class="mt-2"><a href="/publication/PUB200422.html" title="PUB200422">Medical devices - the basics</a></h5> <p>This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.</p> <ul class="list-unstyled"> <li><i class="bi bi-file-regular me-2"></i>ISO 13485:2016</li> <li><i class="bi bi-book-regular me-2"></i>ISO 13485:2016 A practical guide</li> <li><i class="bi bi-file-regular me-2"></i>ISO 14971:2019</li> <li><i class="bi bi-file-regular me-2"></i>ISO/TR 24971:2020</li> </ul> </div> <div class="card-footer d-flex justify-content-between align-items-center"><span class="format text-sm text-muted">English | PDF</span> <div class="orderBasket"><span class="text-xs text-warning text-decoration-line-through"><span>CHF</span> <span class="fw-bold">673</span> </span><span class="ms-2"><span>CHF</span> <span class="fw-bold" id="productPrice_cs59752-pub100422-cs72704-cs74437">606</span></span></div> </div> </div><div class="d-flex justify-content-between align-items-center"> <h3>General information</h3> </div> <ul class="refine"> <li> <div class="" id="publicationStatus"> <div class="entry-label">Status</div> : <span>Published</span> </div> <div class="" id="publicationDate"> <div class="entry-label">Publication date</div> : <span itemprop="releaseDate">2016-03</span> </div> <div class="" id="stageId"> <div class="entry-label">Stage</div> : International Standard under systematic review [<a class="page-scroll" href="#lifecycle">90.20</a>] </div> </li> <li> <div class=""> <div class="entry-label">Edition</div> : 3</div> <div class=""> <div class="entry-label">Number of pages</div> : 36</div> </li> <li> <div> <div class="entry-label">Technical Committee :</div> <span class="entry-name entry-block"> <a title="Quality management and corresponding general aspects for products with a health purpose including medical devices" href="/committee/54892.html">ISO/TC 210</a></span> </div> <div> <div class="entry-label"><abbr class="popover-primary" tabindex="0" role="button" data-bs-toggle="popover" data-bs-custom-class="popover-light text-sm shadow-sm pt-2" data-bs-trigger="focus" data-bs-placement="bottom" data-bs-content="International Classification for Standards">ICS</abbr> :</div> <span class="entry-name entry-block"> <a title="Management systems" href="/ics/03.100.70.html"> 03.100.70</a>  </span> <span class="entry-name entry-block"> <a title="Medical equipment in general" href="/ics/11.040.01.html"> 11.040.01</a>  </span> </div> </li> <li class="text-xs"> <i class="bi-rss-fill me-1 align-baseline text-sm" style="color: #F99000;"></i><a href="/contents/data/standard/05/97/59752.detail.rss">RSS</a> updates</li> </ul> </div> </div> </div> </section> </div> <section id="lifecycle" class="z-2"> <div class="container"> <div class="row"> <div class="col-md-12"> <h3>Life cycle</h3> <div class="lifecycle"> <ul class="steps"> <li class="time-step"> <h4 class="ms-sm-3 text-muted">Previously</h4> <div class="step step-dark"> <div class="step-item"> <div class="section-head">Withdrawn</div> <h5><a href="/standard/36786.html">ISO 13485:2003</a></h5> </div> <div class="step-item"> <div class="section-head">Withdrawn</div> <h5><a href="/standard/54724.html">ISO 13485:2003/Cor 1:2009</a></h5> </div> </div> </li> <li class="time-step"> <h4 class="ms-sm-3 text-muted">Now</h4> <div class="step step-success active"> <div class="section-head">Published</div> <h5>ISO 13485:2016</h5> <br/>A standard is reviewed every 5 years<br/><a data-bs-toggle="collapse" role="button" aria-expanded="false" href="#stages" class="dropdown-toggle current-stage text-sm collapsed">Stage: <strong>90.20</strong> (Under review)</a> </div> <ul class="stages collapse" id="stages"> <li class="dropdown alert-info"> <a href="javascript:void(0)" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">00</span> <div class="stage-title">Preliminary</div> </a> </li> <li class="dropdown alert-info"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">10</span> <div class="stage-title">Proposal</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#10_99"> <span class="stage-code">10.99</span> <span class="stage-date">2011-12-08</span> <div class="stage-title"> New project approved</div> </a> </li></ul> </li> <li class="dropdown alert-info"> <a href="javascript:void(0)" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">20</span> <div class="stage-title">Preparatory</div> </a> </li> <li class="dropdown alert-info"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">30</span> <div class="stage-title">Committee</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#30_00"> <span class="stage-code">30.00</span> <span class="stage-date">2011-12-08</span> <div class="stage-title"> Committee draft (CD) registered</div> </a> </li><li > <a href="/stage-codes.html#30_20"> <span class="stage-code">30.20</span> <span class="stage-date">2011-12-09</span> <div class="stage-title"> CD consultation initiated</div> </a> </li><li > <a href="/stage-codes.html#30_60"> <span class="stage-code">30.60</span> <span class="stage-date">2012-03-11</span> <div class="stage-title"> Close of comment period</div> </a> </li><li > <a href="/stage-codes.html#30_99"> <span class="stage-code">30.99</span> <span class="stage-date">2013-12-19</span> <div class="stage-title"> CD approved for registration as DIS</div> </a> </li></ul> </li> <li class="dropdown alert-info"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">40</span> <div class="stage-title">Enquiry</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#40_00"> <span class="stage-code">40.00</span> <span class="stage-date">2014-01-08</span> <div class="stage-title"> DIS registered</div> </a> </li><li > <a href="/stage-codes.html#40_20"> <span class="stage-code">40.20</span> <span class="stage-date">2014-02-20</span> <div class="stage-title"> DIS ballot initiated: 12 weeks</div> </a> </li><li > <a href="/stage-codes.html#40_60"> <span class="stage-code">40.60</span> <span class="stage-date">2014-07-22</span> <div class="stage-title"> Close of voting</div> </a> </li><li > <a href="/stage-codes.html#40_93"> <span class="stage-code">40.93</span> <span class="stage-date">2014-09-09</span> <div class="stage-title"> Full report circulated: decision for new DIS ballot</div> </a> </li><li > <a href="/stage-codes.html#40_00"> <span class="stage-code">40.00</span> <span class="stage-date">2015-01-27</span> <div class="stage-title"> DIS registered</div> </a> </li><li > <a href="/stage-codes.html#40_20"> <span class="stage-code">40.20</span> <span class="stage-date">2015-02-06</span> <div class="stage-title"> DIS ballot initiated: 12 weeks</div> </a> </li><li > <a href="/stage-codes.html#40_60"> <span class="stage-code">40.60</span> <span class="stage-date">2015-05-07</span> <div class="stage-title"> Close of voting</div> </a> </li><li > <a href="/stage-codes.html#40_99"> <span class="stage-code">40.99</span> <span class="stage-date">2015-07-29</span> <div class="stage-title"> Full report circulated: DIS approved for registration as FDIS</div> </a> </li></ul> </li> <li class="dropdown alert-info"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">50</span> <div class="stage-title">Approval</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#50_00"> <span class="stage-code">50.00</span> <span class="stage-date">2015-10-05</span> <div class="stage-title"> Final text received or FDIS registered for formal approval</div> </a> </li><li > <a href="/stage-codes.html#50_20"> <span class="stage-code">50.20</span> <span class="stage-date">2015-10-29</span> <div class="stage-title"> Proof sent to secretariat or FDIS ballot initiated: 8 weeks</div> </a> </li><li > <a href="/stage-codes.html#50_60"> <span class="stage-code">50.60</span> <span class="stage-date">2015-12-31</span> <div class="stage-title"> Close of voting. Proof returned by secretariat</div> </a> </li></ul> </li> <li class="dropdown alert-success"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">60</span> <div class="stage-title">Publication</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#60_00"> <span class="stage-code">60.00</span> <span class="stage-date">2016-01-11</span> <div class="stage-title"> International Standard under publication</div> </a> </li><li > <a href="/stage-codes.html#60_60"> <span class="stage-code">60.60</span> <span class="stage-date">2016-02-25</span> <div class="stage-title"> International Standard published</div> </a> </li></ul> </li> <li class="dropdown bg-success active"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span 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<span class="stage-code">90.60</span> <span class="stage-date"></span> <div class="stage-title"> Close of review</div> </a> </li><li > <a href="/stage-codes.html#90_99"> <span class="stage-code">90.99</span> <span class="stage-date"></span> <div class="stage-title"> Withdrawal of International Standard proposed by TC or SC</div> </a> </li></ul> </li> <li class="dropdown alert-muted"> <a href="javascript:void(0)" class="dropdown-toggle" data-bs-display="static" data-bs-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> <span class="stage-code">95</span> <div class="stage-title">Withdrawal</div> </a> <ul class="dropdown-menu"> <li > <a href="/stage-codes.html#95_99"> <span class="stage-code">95.99</span> <span class="stage-date"></span> <div class="stage-title"> Withdrawal of International Standard</div> </a> </li></ul> </li> </ul> </li> </ul> </div> </div> </div> </div> </section> <section class="text-center pt-0" id="section-sdg"> <div class="container"> <div 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ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes