Co je ISO 13485 - kvalita zdratnických prostředku

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class="pageHeaderLocalRegionSelItemLink" lang="nl-NL"> <span class="localLangTrans">Nederland (Nederlands)</span> <span class="localLang" lang="en">Netherlands (Dutch)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pl-pl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pl-PL"> <span class="localLangTrans">Polska (polski)</span> <span class="localLang" lang="en">Poland (Polish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-br/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-BR"> <span class="localLangTrans">Brasil (Português)</span> <span class="localLang" lang="en">Brazil (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-pt/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-PT"> <span class="localLangTrans">Portugal (português)</span> <span class="localLang" lang="en">Portugal (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a 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</li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> Změna klimatu a udržitelnost </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Zpět menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/cs-cz/zmena-klimatu-udrzitelnost/" target="_self"> <span class="text">Změna klimatu a udržitelnost</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iso-14064/" target="_self"> <span class="text">ISO 14064</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iso-14067-sklenikove-plyny-uhlikova-stopa-vyrobku/" target="_self"> <span class="text">ISO 14067</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iso-50001/" target="_self"> <span class="text">ISO 50001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/smeta/" target="_self"> <span class="text">Sedex Members Ethical Trade Audit (SMETA)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/eu-ets3/" target="_self"> <span class="text">EU ETS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/odpovedne-rizeni-plastu-rpm/" target="_self"> <span class="text">Odpovedne rizeni plastu (RPM)</span> </a> </li> </ul> </li> <li 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<span class="text">ISO 27001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="https://www.lrqa.com.cn/iso-27701/" target="_self"> <span class="text">ISO 27701</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iso-20000/" target="_self"> <span class="text">ISO/IEC 20000-1</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iso-22301/" target="_self"> <span class="text">ISO 22301</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> Automobilový průmysl a letecký průmysl </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Zpět menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/cs-cz/automobilovy-letecky-prumysl-doprava/" target="_self"> <span class="text">Automobilový průmysl a letecký průmysl</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iris-zeleznice/" target="_self"> <span class="text">IRIS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/iatf-16949/" target="_self"> <span class="text">IATF 16949</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/cs-cz/as9100/" target="_self"> <span class="text">AS 9100</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a 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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" > Splňte požadavky v odvětví zdravotnických prostředků. </h1> <p class="heroSummary" > ISO 13485 poskytuje výrobcům zdravotnických prostředků komplexní rámec pro zajištění kvality výrobků a shody s legislativními požadavky. </p> <p class="heroSubtitle" > Co je ISO 13485 - kvalita zdratnických prostředku | LRQA </p> <ul class="heroList" > <li class="heroListItem"> <a href="/cs-cz/kontaktujte-nas/poptavka/" target="_blank" class="arrowLink arrowLinkBold">Kontaktujte nás</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="CZ-BA+Shared+global+sticky+CTA+-+BA"> <a href="tel:+420 725 546 351" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> +420 725 546 351 </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"> Vyžádat nabídku </span> </button> <dialog id="modal2"> <div class="dialogWrap"> <button type="button" class="innerDialogButton"> <svg focusable="false" class="white"> <title>Close</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </button> <div class="dialogWrapInner"> <div class="stickyCtaDialog white"> <div class="stickyCtaDialogContent"> <h3 class="stickyCtaDialogHeader">Vyžádat nabídku</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-04/c3k27g?" loading="lazy" id="iFrameResizer2" style="overflow: hidden;" scrolling="no"> </iframe> </div> </div> </div> </div> </div> </dialog> </div> </section> <section class="grid stickyContentArea" > </section> <section class="grid mainContent" > <div 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="/cs-cz/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/cs-cz/iso-13485/certifikace/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Certifikace </span> </a> </li> <li class="swipeNavListItem"> <a href="/cs-cz/iso-13485/training/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Školení </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>Přehled</h4><p>Ve značně regulovaném světě výroby zdravotnických prostředků mají organizace povinnost prokázat, že každý výrobek splňuje očekávání zákazníků i platné legislativní požadavky. Společnost LRQA podporuje klienty v jejich snaze vyhovět přísným požadavkům standardu ISO 13485 a nastavit vývojové cykly výrobků pro zajištění včasného uvedení na trh.</p> <p>Mezinárodní standard pro systémy managementu kvality zdravotnických prostředků, ISO 13485:2016 (Zdravotnické prostředky – Systémy managementu kvality – Požadavky pro účely předpisů), byl zveřejněn mezinárodním akreditačním forem (International Accreditation Forum, IAF) 1. března 2016 a organizace mají na přechod z předchozích verzí tři roky. ISO 13485:2012 si do konce přechodového období uchová status harmonizovaného standardu a předpokládá se, že tak společnosti vyhoví požadavkům v oblasti ISO 13485. </p> <p>ISO 13485:2016 zavádí řadu malých, ale podrobných změn vyžadujících komplexnější dokumentaci pro pracovní prostředí, řízení rizik, kontrolu návrhu a legislativní požadavky. Revidovaný standard zahrnuje přístup k systémům managementu kvality založeného na rizicích, větší zaměření na legislativní požadavky a odpovědnost vrcholového vedení, lepší nástroje pro kontrolu nad dodavateli a činnostmi smluvních stran a důraz na řízení rizik napříč životním cyklem výrobku.</p> <p>ISO 13485 je určen výrobcům zdravotnických prostředků i organizacím, které tyto výrobce podporují. Zdůrazňuje povinnost výrobců zajistit, aby prostředky neustále vyhovovaly potřebám zákazníků a splňovaly platné legislativní požadavky.</p> <p>ISO 13485:2016 nahradí všechny předchozí verze v březnu 2019. </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>Přínosy standardu ISO 13485</h4><h4>Volnost obchodu</h4> <p>Mnoho výrobců vyžaduje po dodavatelích, aby měli certifikaci dle ISO 13485, tudíž je standard předpokladem pro zachování konkurenceschopnosti.</p> <h4>Konsistentní kvalita</h4> <p>Na kvalitě zdravotnických prostředků závisí bezpečnost pacientů. Certifikace dle ISO 13485 poskytuje výrobcům jistotu, že organizace napříč dodavatelským řetězcem dosahují a zajišťují shodu s legislativními požadavky.</p> <h4>Řízení rizik</h4> <p>Certifikace dle ISO 13485 je aktivní způsob, jak se věnovat prevenci nehod a umisťuje bezpečnost pacientů na první místo. To pomáhá minimalizovat riziko poškození reputace výrobců vlivem defektů výrobků.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>Potřebujete pomoci s ISO 13485?</h4><p>Coby mezinárodně uznávaný standard v oblasti výroby zdravotnických prostředků Vám ISO 13485 pomáhá porazit konkurenci prostřednictvím minimalizace rizik napříč vývojovým cyklem výrobku.</p> <p>Díky systematickému přístupu společnosti LRQA získáte patřičnou podporu během všech fází vývoje výrobku, což usnadní včasné uvedení výrobku na trh.</p> <p>Společnost LRQA poskytuje širokou řadu služeb v oblasti ISO 13485, včetně <a href="/cs-cz/iso-13485/certifikace/?epslanguage=cs-CZ">certifikace</a>, <a href="/cs-cz/iso-13485/certifikace/?epslanguage=cs-CZ">rozdílové analýzy</a> a školení. Všechny jsou navrženy tak, aby Vás podporovaly na cestě za úspěšným dosažením shody s požadavky standardu.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>Proč s námi spolupracovat?</h4><h4>Zaměřeno na jistotu</h4> <p>Společnost LRQA pokaždé s analytickou přesností důkladně prozkoumává každý proces systému managementu kvality, aby učinila přesné závěry.</p> <h4>Odborné znalosti</h4> <p>Společnost LRQA má akreditaci britského národního akreditačního orgánu UKAS (United Kingdom Accreditation Service) a kanadské rady pro normy SCC (Standards Council of Canada) k provádění certifikace dle ISO 13485:2016 a jsme také autorizovanou auditorskou organizací v rámci programu MDSAP. Na&scaron;i auditoři jsou specialisty v oboru, které vybíráme pro potřeby Va&scaron;eho podniku, díky čemuž mohou provést efektivní audit Va&scaron;eho systému managementu kvality, který garantuje okamžitý i dlouhodobý příznivý dopad.</p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12" id="S02.18+Management+Systems+request+for+information+about+service"> <div class="wysiwyg" > <h4 style="text-align: center;">Chcete získat více informací o této službě?</h4><p style="text-align: center;"><a href="https://info.lrqa.com/l/12702/2021-10-04/c3k27g?website_url=&website_sector=" class="cta">Kontaktujte nás</a></p> </div></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> <h2 class="carouselBlockHeading" > <strong>PŘÍPADOVÉ STUDIE</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 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Co je ISO 13485 - kvalita zdratnických prostředku | LRQA