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ISO 13485 - System zarzadzania jakością dla wyrobów medycznych | LRQA
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lang="en">Belgium (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/fr-fr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="fr-FR"> <span class="localLangTrans">France (français)</span> <span class="localLang" lang="en">France (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/id-id/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="id-ID"> <span class="localLangTrans">Indonesia (Indonesia)</span> <span class="localLang" lang="en">Indonesia (Indonesian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/it-it/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="it-IT"> <span class="localLangTrans">Italia (italiano)</span> <span class="localLang" lang="en">Italy (Italian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-ae/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-AE"> <span class="localLangTrans">Middle East (English)</span> <span 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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 href="/ro-ro/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ro-RO"> <span class="localLangTrans">România (română)</span> <span class="localLang" lang="en">Romania (Romanian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-sg/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-SG"> <span class="localLangTrans">Southeast Asia (English)</span> <span class="localLang" lang="en">Southeast Asia (English)</span> </a> </li> <li 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src="/static/assets/search-grey.svg" loading="eager" style="display:none;" /> <main id="content" tabindex="-1"> <section class="grid headerContentArea" > <div class="hero heroVariant2 heroAlignCentre canvas canvasNavy col-12" id="H1+-+ISO+13485+Medical+Quality+Management+System"> <div class="image" > <picture><source srcset="/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 1024w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1280w,/cdn-cgi/image/width=1440,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 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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" > ISO 13485 System zarzadzania jakością dla wyrobów medycznych </h1> <p class="heroSummary" > ISO 13485 stanowi całościową ramę dla producentów wyrobów medycznych zapewniającą wysoką jakość produktów i zgodność z wymogami prawnymi. </p> </div> </div><div class="stickyCtaContainer twoItems" id="PL-BA+Shared+global+sticky+CTA+-+BA"> <a href="tel: +48 58 555 75 00" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> Zadzwoń do nas natychmiast:+48 58 555 75 00 </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"> Poproś o wycenę </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">Poproś o wycenę</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-04/c3k23v?" 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="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Medical+Quality+Management+System+Overview"> <div class="wysiwyg" > <h4>Zarys og贸lny</h4><p>W 艣ci艣le regulowanym sektorze produkcji wyrob贸w medycznych, organizacje maj膮 obowi膮zek wykaza膰, 偶e ka偶dy produkt spe艂nia zar贸wno oczekiwania klient贸w jak i stosowne wymogi prawne. LRQA wspiera swoich klient贸w w ich staraniach o sprostanie surowym wymogom ISO 13485, dostrajaj膮c product cykle rozwoju produkt贸w, aby zapewni膰 terminowe wprowadzanie ich na rynek.</p> <p>Mi臋dzynarodowa norma systemu zarz膮dzania (QMS) dla wyrob贸w medycznych, ISO 13485:2016 (Wyroby medyczne - Systemy zarz膮dzania jako艣ci膮 - Wymagania do cel贸w przepis贸w prawnych) zosta艂a opublikowana 1 maja 2016 roku a Mi臋dzynarodowe Forum Akredytacji (IAF) da艂o certyfikowanym organizacjom trzy lata na migracj臋 z poprzednich wersji. Do ko艅ca okresu transformacji ISO 13485:2012 pozostaje zharmonizowan膮 norm膮 i dowodem kompatybilno艣ci.</p> <p>ISO 13485:2016 wprowadza szereg delikatnych, lecz szczeg贸艂owych zmian wymagaj膮cych dok艂adniejszej dokumentacji na temat 艣rodowiska pracy, zarz膮dzania ryzykiem, kontroli projektu i wymog贸w prawnych. Zaktualizowana norma wymusza oparte na ryzyku podej艣cie do QMS, zwi臋ksza nacisk na spe艂nianie wymog贸w prawnych i odpowiedzialno艣膰 najwy偶szego zarz膮du firmy, wzmacnia kontrol臋 nad dostawcami i zadaniami zleconymi i podkre艣la znaczenie zarz膮dzania ryzykiem w ca艂ym cyklu rozwoju produktu.</p> <p>ISO 13485 dotyczy zar贸wno producent贸w wyrob贸w medycznych jak i organizacji, kt贸re ich wspieraj膮. Podkre艣la obowi膮zek producenta, aby jego wyroby konsekwentnie spe艂nia艂y wymagania klienta i odpowiednich regulacji prawnych.</p> <p>Zaktualizowana ISO 13485:2016 zast膮pi wszystkie poprzednie wersje w marcu 2019. </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>Korzy艣ci z ISO 13485</h4><h4>Swobodny handel</h4> <p>Wielu producent贸w wymaga od swoich dostawc贸w uzyskania certyfikatu ISO 13485, jako podstawowy warunek utrzymania konkurencyjno艣ci.</p> <h4>Sta艂a jako艣膰</h4> <p>Bezpiecze艅stwo pacjenta zale偶y od jako艣ci wyrob贸w medycznych. Certyfikat ISO 13485 daje producentom pewno艣膰, 偶e organizacje w ich 艂a艅cuchu dostaw mog膮 osi膮gn膮膰 i utrzyma膰 zgodno艣膰 z wymogami.</p> <h4>Zarz膮dzanie ryzykiem</h4> <p>Uzyskanie certyfikatu ISO 13485 to spos贸b, aby aktywnie zapobiega膰 wypadkom i stawia膰 na pierwszym miejscu bezpiecze艅stwo pacjenta. To pomaga r贸wnie偶 zminimalizowa膰 ryzyko utraty reputacji przez producenta spowodowanej wadami produktu.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>Potrzebujesz pomocy w uzyskaniu ISO 13485?</h4><p>Jako mi臋dzynarodowa norma w produkcji wyrob贸w medycznych, ISO 13485 pomo偶e Ci pokona膰 konkurencj臋 poprzez ograniczenie ryzyka w ca艂ym cyklu rozwoju produktu.</p> <p>Systematyczne podej艣cie LRQA zapewni Ci odpowiednie wsparcie na ka偶dym etapie rozwoju produktu pozwalaj膮c na terminowe wprowadzenie go na rynek.</p> <p>LRQA dostarcza szerok膮 gam臋 us艂ug ISO 13485, w tym<a href="/pl-pl/iso-13485/certyfikacja/?epslanguage=pl-PL">certyfikacj臋</a> , <a href="/pl-pl/iso-13485/certyfikacja/?epslanguage=pl-PL">analiz臋 luk</a> i szkolenia, i wszystkie s膮 zaprojektowane z my艣l膮 o wsparciu Twojej organizacji w drodze do uzyskania zgodno艣ci z norm膮.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>Dlaczego warto nas wybra膰?</h4><h4>Zaanga偶owanie w us艂ugi assurance</h4> <p>LRQA ka偶dy system zarz膮dzania bada z surow膮, analityczn膮 precyzj膮, aby za ka偶dym razem wyci膮ga膰 trafne wnioski.</p> <h4>Wiedza techniczna</h4> <p>LRQA posiada akredytacj臋 Brytyjskiego Urz臋du Akredytacyjnego (UKAS) i Kanadyjskiej Rady ds. Standardów (SCC) do przyznawania certyfikatu ISO 13485:2016, oraz mamy status Authorised Auditing Organisation w programie MDSAP. Nasi auditorzy to specjali艣ci z bran偶y, których dobieramy odpowiednio do Twoich potrzeb biznesowych, co pozwala na skuteczny i ca艂o艣ciowy audit Twoich QMS, który wp艂ynie na nie pozytywnie w krótszej jak i dalszej perspektywie.</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;">Chcesz wiedzie膰 wi臋cej o tej us艂udze?</h4><p style="text-align: center;"><a href="https://info.lrqa.com/l/12702/2021-10-04/c3k23v?website_url=&website_sector=" class="cta">Skontaktuj si臋 z nami</a></p> </div></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> <h2 class="carouselBlockHeading" > <strong>STUDIA PRZYPADKÓW</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 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1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/group/532-x-421-asco-website.jpg 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/group/532-x-421-asco-website.jpg 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/group/532-x-421-asco-website.jpg 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/group/532-x-421-asco-website.jpg 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/group/532-x-421-asco-website.jpg 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