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ISO 13485 Sistemas de Gestão da Qualidade de Dispositivos Médicos
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srcset="/cdn-cgi/image/width=320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 320w,/cdn-cgi/image/width=640,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 640w,/cdn-cgi/image/width=768,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 768w,/cdn-cgi/image/width=960,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 960w,/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 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3840w,/cdn-cgi/image/width=4320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 4320w,/cdn-cgi/image/width=5760,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 5760w" sizes="100vw" media="" ><img src="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg" alt="Stethoscope on tablet" loading="eager" decoding="auto" fetchpriority="auto" class="heroImage" fetchpriority="auto" ></picture> </div> <div class="titleBlock"> <h1 class="heroTitle" > Cumprir os requisitos do setor dos dispositivos médicos. </h1> <p class="heroSummary" > A ISO 13485 fornece um quadro abrangente aos fabricantes de dispositivos médicos para garantir a qualidade dos produtos e a conformidade regulamentar. </p> <p class="heroSubtitle" > ISO 13485 Sistemas de Gestão da Qualidade de Dispositivos Médicos </p> <ul class="heroList" > <li class="heroListItem"> <a href="/pt-pt/iso-13485/certificacao/" class="arrowLink arrowLinkBold">Serviços ISO 13485</a> </li> </ul> </div> </div><div class="stickyCtaContainer " id="Shared+global+sticky+CTA+-+BA"> <div class="stickyCtaButtons"> <div class="stickyCtaButtonsInner"> <a href="tel:+351 21 124 4500" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> +351 21 124 4500 </span> </a> <button type="button" class="stickyCtaButton modalButton" data-dialog="modal2" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> Pedir orçamento </span> </button> <dialog id="modal2"> <div class="dialogWrap"> <button type="button" class="innerDialogButton"> <svg focusable="false" class="white"> 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class="quickLinks col-12 spacingSmall canvas canvasNavy" id="ISO+13485+Page+Tabs"> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList" > <li class="swipeNavListItem"> <a href="/pt-pt/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/pt-pt/iso-13485/certificacao/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Serviços de Certificação </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Medical+Quality+Management+System+Overview"> <div class="wysiwyg" > <h4>Visão geral</h4><p>No mundo altamente regulamentado do fabrico de dispositivos médicos, as organizações têm o dever de mostrar que cada produto cumpre tanto as expectativas dos clientes como os regulamentos aplicáveis. A LRQA apoia os clientes nos seus esforços para cumprir os rigorosos requisitos da ISO 13485, aperfeiçoando os ciclos de vida de desenvolvimento de produtos para garantir um lançamento no mercado no momento certo.</p> <p>A norma de sistemas de gestão da qualidade (QMS) internacional para dispositivos médicos, a ISO 13485:2016 (dispositivos médicos – sistemas de gestão da qualidade – requisitos para fins regulamentares) foi publicada a 1 de março de 2016, com o Fórum Internacional de Acreditação (IAF), dando às organizações certificadas três anos para efetuarem a transição das versões anteriores. A ISO 13485:2012 mantém o seu estatuto como a norma harmonizada e a presunção de conformidade, até o final do período de transição.</p> <p>A ISO 13485:2016 introduz uma série de mudanças subtis, mas detalhadas que exigem documentação mais completa sobre o ambiente de trabalho, gestão de riscos, controlo de conceção e requisitos regulamentares. A norma revista inclui a necessidade de uma abordagem baseada nos riscos para o SGQ, um maior foco nos requisitos regulamentares e nas responsabilidades da administração de topo, maior controlo sobre os fornecedores e atividades subcontratadas e uma ênfase na gestão de riscos ao longo do ciclo de vida do produto.</p> <p>A ISO 13485 aplica-se a fabricantes de dispositivos médicos e a organizações que apoiam os fabricantes de dispositivos médicos. Sustenta o dever, por parte dos fabricantes, de garantir que os dispositivos cumprem de forma consistente os requisitos do cliente e os regulamentares aplicáveis.</p> <p>A ISO 13485:2016 atualizada substitui todas as versões anteriores em março de 2019. </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>Benefícios da ISO 13485</h4><h4>Liberdade para comercializar</h4> <p>Muitos fabricantes exigem que os fornecedores tenham <a href="/pt-pt/iso-13485/certificacao/?epslanguage=pt-PT">certificação ISO 13485</a>, tornando a norma um pré-requisito para se manterem competitivos.</p> <h4>Qualidade consistente</h4> <p>A segurança dos doentes depende da qualidade dos produtos médicos. A certificação ISO 13485 dá aos fabricantes a confiança de que as organizações conseguem garantir e manter a conformidade em toda a cadeia de fornecimento.</p> <h4>Gestão de riscos</h4> <p>Obter a <a href="/pt-pt/iso-13485/certificacao/?epslanguage=pt-PT">certificação ISO 13485</a> é um método proativo para evitar incidentes e priorizar a segurança dos doentes. Isso ajuda a minimizar o risco de danos à reputação dos fabricantes provocados por defeitos do produto.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>Precisa de ajuda com a ISO 13485?</h4><p>Como a norma internacionalmente reconhecida no mundo do fabrico de dispositivos médicos, a ISO 13485 ajuda-o a vencer a concorrência ao minimizar os riscos ao longo do ciclo de vida do desenvolvimento de produtos.</p> <p>Graças a abordagem sistemática da LRQA, vai receber o apoio adequado em cada fase de desenvolvimento de produtos, facilitando o lançamento no mercado no momento certo.</p> <p>A LRQA presta um ampla conjunto de serviços ISO 13485, incluindo <a href="/pt-pt/iso-13485/certificacao/?epslanguage=pt-PT">certificação</a>, <a href="/pt-pt/iso-13485/certificacao/?epslanguage=pt-PT">análise de falhas</a> e formação, todos os quais foram concebidos para apoiar o seu rumo até ao cumprimento bem-sucedido.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>Porquê trabalhar connosco?</h4><h4>Dedicação à melhoria</h4> <p>A LRQA explora cada processo do sistema de gestão da qualidade com precisão rigorosa e analítica para tirar sempre conclusões precisas.</p> <h4>Especialização técnica</h4> <p>A LRQA dispõe de acreditação pelo Serviço de Acreditação do Reino Unido (UKAS) e pelo Conselho de Normas do Canadá (SCC) para fornecer certificação ISO 13485:2016 e é também uma Organização de Auditoria Autorizada ao abrigo do programa MDSAP. Os nossos auditores são especialistas do setor, selecionados com base nas suas necessidades de negócio, permitindo uma auditoria eficaz do seu SGQ e impulsionando impactos positivos a curto e a longo prazo.</p> </div></div> </section> <section class="grid bottomContent" > <div class="carouselBlock canvas canvasNavy col-12 spacingLarge" id="S03.01+Generic+insights+carousel+(2)"> </div><div class="carouselBlock canvas canvasWhite col-12 spacingSmall" id="S03.03+Generic+events+list"> </div> </section> </main> <footer class="footer canvas canvasNavy"> <div class="footerLogo"> <img decoding="auto" fetchpriority="auto" class="" src="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png" srcset="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 120w,/cdn-cgi/image/width=150,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 150w,/cdn-cgi/image/width=240,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 240w,/cdn-cgi/image/width=300,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 300w,/cdn-cgi/image/width=360,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 360w,/cdn-cgi/image/width=450,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 450w" sizes="(min-width: 1280px) 150px, 120px" alt="" loading="lazy" width="500" height="174" /> <ul class="socialList"> <li class="socialListItem"> <a href="https://twitter.com/lrqa" class="socialListItemLink" rel="noopener"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/twitter2.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/twitter2.png 60w" sizes="20px" alt="" loading="lazy" class="" width="21" height="22" /> </a> </li> <li class="socialListItem"> <a href="https://www.linkedin.com/company/lrqa" class="socialListItemLink" rel="noopener"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/linkedin-icon-1.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/linkedin-icon-1.png 60w" sizes="20px" alt="LinkedIn icon in mint green" loading="lazy" class="" width="134" height="134" /> </a> </li> </ul> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/pt-pt/quem-somos/" class="footerListItemLink">Quem somos</a> </li> <li class="footerListItem"> <a href="/en/careers/" class="footerListItemLink">Carreiras</a> </li> <li class="footerListItem"> <a href="/pt-pt/documentos/" class="footerListItemLink">Recursos</a> </li> </ul> <div class="wysiwyg"> <p style="text-align: center;">LRQA and any variants are trading names of LRQA Group Limited, its subsidiaries and affiliates. 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