{"id":1019,"date":"2025-08-12T21:16:26","date_gmt":"2025-08-12T21:16:26","guid":{"rendered":"https:\/\/birincidanismanlik.com\/?page_id=1019"},"modified":"2025-08-13T13:04:22","modified_gmt":"2025-08-13T10:04:22","slug":"iso-13485-2016","status":"publish","type":"page","link":"https:\/\/sanbirgrup.com\/birincidanismanlik\/danismanlik\/iso-13485-2016\/","title":{"rendered":"ISO 13485:2016"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t\t\t
Dan\u0131\u015fmanl\u0131k<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
Devlet Destekleri ve Te\u015fvikler<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Yat\u0131r\u0131m Te\u015fvik Belgesi<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nKOSGEB Destekleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nTicaret Bakanl\u0131\u011f\u0131 Destekleri<\/a><\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nT\u00dcB\u0130TAK Destekleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nSanayi ve Teknoloji Bakanl\u0131\u011f\u0131 Destekleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nSGK Te\u015fvikleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nKalk\u0131nma Ajanslar\u0131 Te\u015fvikleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\u0130\u015eKUR Destekleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nAvrupa Birli\u011fi Hibe ve Te\u015fvik Programlar\u0131<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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IPARD Projeleri<\/a><\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nK\u0131rsal Kalk\u0131nma Projeleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nKalite Belgelendirme<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 9001: 2015<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 14001:2015<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nISO 22000:2018<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 45001:2018<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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ISO 27001:2013<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 10002:2018<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 13485:2016<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 20000-1:2011<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 22301:2019<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 50001:2018<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 31000:2018<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nISO 28000:2007<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nISO 27701:2019<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nISO 14064-1<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nGMP<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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AS 9100 Havac\u0131l\u0131k ve Uzay Sanayi Kalite Y\u00f6netim Sistemi<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nTesis G\u00fcvenlik Belgesi<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nHelal Belgelendirme<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\nTSE Belgelendirme<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nSat\u0131\u015f Sonras\u0131 Hizmet Yeterlilik Belgesi<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\nCE Belgelendirme<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\nMarka Tescil ve Patent \u0130\u015flemleri<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\nMarka Ara\u015ft\u0131rma Ba\u015fvuru S\u00fcreci ve Tescil \u0130\u015flemleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\u00dcr\u00fcn Faydal\u0131 Model \u0130\u015flemleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\u00dcr\u00fcn Patent \u0130\u015flemleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\u00dcr\u00fcn End\u00fcstriyel Tasar\u0131m \u0130\u015flemleri<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\nSanayi Sicil Belgesi<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\nKapasite Raporu<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\nYerli Mal\u0131 Belgesi<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\u0130lk Yard\u0131m E\u011fitimi ve Sertifikaland\u0131rma<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\nHijyen E\u011fitimi ve Sertifikaland\u0131rma<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\nMesleki E\u011fitim ve Sertifikaland\u0131rma<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\nMesleki Yeterlilik Kurumu Sertifikaland\u0131rma<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\nRuhsatlar<\/a>\n\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\u0130\u015fyeri A\u00e7ma ve \u00c7al\u0131\u015fma Ruhsat\u0131<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\u0130tfaiye Uygunluk Raporu<\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ISO 13485:2016<\/h3>

ISO 13485: 2016 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi Nedir?<\/h3>

T\u0131bbi cihaz \u00fcretimi ve hizmeti sekt\u00f6r\u00fcnde faaliyet g\u00f6steren kurulu\u015flar\u0131 da ilgilendiren ISO 13485 standard\u0131, t\u0131bbi cihazlar\u0131n yasal mevzuatlara uygun bir \u015fekilde \u00fcretimi ve servisine zemin haz\u0131rlar. ISO 13485 belgesine sahip olan kurulu\u015flar, ISO taraf\u0131ndan alt\u0131 \u00e7izilen kural ve \u015fartlara uyum sa\u011flad\u0131\u011f\u0131 ve sa\u011fl\u0131kl\u0131 bir \u015fekilde hizmet verdiklerini beyan etmi\u015f olur.<\/p>

\u00a0<\/p>

ISO 13485 belgesi standard\u0131 ISO 9001 standard\u0131 temel al\u0131narak olu\u015fturulmu\u015f, Medikal t\u0131bbi cihazlar i\u00e7in \u00f6zel \u015fartlar i\u00e7eren uluslararas\u0131 bir standartt\u0131r. ISO 13485 belgesi standard\u0131n\u0131n temel amac\u0131, kalite y\u00f6netim sistemleri i\u00e7in uyumla\u015ft\u0131r\u0131lm\u0131\u015f t\u0131bbi cihaz mevzuat\u0131 \u015fartlar\u0131n\u0131 kolayla\u015ft\u0131rmakt\u0131r.<\/p>

\u00a0<\/p>

ISO 13485 belgesi, kurulu\u015funuzun s\u00fcrekli geli\u015fmesini ve b\u00fcy\u00fcmesini sa\u011flayan i\u015f geli\u015ftirici bir belgedir. \u0130\u015finizin \u00f6ne \u00e7\u0131kmas\u0131na, rekabet avantaj\u0131 kazanmas\u0131na yard\u0131mc\u0131 olur. Kurulu\u015funuzun b\u00fcy\u00fckl\u00fc\u011f\u00fc ne olursa olsun, ISO 13485 T\u0131bbi Cihazlar \u0130\u00e7in Kalite Y\u00f6netim Sistemi t\u00fcm operasyonel s\u00fcre\u00e7lerinizi en iyi \u015fekilde izlemenize ve y\u00f6netmenize olanak sa\u011flar. D\u00fcnyan\u0131n en yayg\u0131n T\u0131bbi Cihazlar y\u00f6netim standard\u0131 olan ISO 13485, kurulu\u015flar\u0131n hizmet ve performans y\u00f6netimi konusunda kalitelerini art\u0131rmaya ve s\u00fcreklilik sa\u011flanmas\u0131na imkan tan\u0131r.<\/p>

\u00a0<\/p>

ISO 13485: 2016 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi Belgesini Kimler Almal\u0131?<\/h3>

\u00a0 \u00a0– \u00dcretim \u2013 imalat yapan t\u00fcm t\u0131bbi cihaz \u00fcreticileri<\/p>

\u00a0<\/p>

ISO 13485: 2016 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi Faydalar\u0131 Nelerdir?<\/h3>

\u00a0 \u00a0– Her b\u00fcy\u00fckl\u00fckte i\u015fletme ve her tip \u00fcr\u00fcne uygulanabilir.<\/p>

\u00a0 \u00a0– Uluslararas\u0131 ge\u00e7erlili\u011fe sahip ISO 13485 belgesi ile piyasa ko\u015fullar\u0131nda rekabet \u015fans\u0131n\u0131n artmas\u0131 sa\u011flar.<\/p>

\u00a0 \u00a0– Pazarda daha istikrarl\u0131 bir rakip olman\u0131za olanak sa\u011flar.<\/p>

\u00a0 \u00a0– \u0130yi bir T\u0131bbi Cihazlar Kalite Y\u00f6ntemi m\u00fc\u015fteri ihtiya\u00e7lar\u0131n\u0131 kar\u015f\u0131laman\u0131za yard\u0131m eder.<\/p>

\u00a0 \u00a0– Daha etkin \u00e7al\u0131\u015fma y\u00f6ntemleri zaman, para ve kaynak tasarrufu sa\u011flar.<\/p>

\u00a0 \u00a0– \u0130yile\u015ftirilmi\u015f operasyonlar performans\u0131 hatalar\u0131 azalt\u0131r, kar\u0131 art\u0131r\u0131r.<\/p>

\u00a0 \u00a0– Daha etkin i\u00e7 s\u00fcre\u00e7lerle \u00e7al\u0131\u015fanlar\u0131 te\u015fvik edip, onlar\u0131 s\u00fcrece dahil eder.<\/p>

\u00a0 \u00a0– Kurumsalla\u015fma yolunda \u00f6nemli bir ad\u0131md\u0131r.<\/p>

\u00a0 \u00a0– \u0130hale \u015fartnamelerinde genellikle ISO 13485 istendi\u011fi i\u00e7in, ihale ile i\u015f al\u0131mlar\u0131nda ISO 9001 ile birlikte avantaj sa\u011flar.<\/p>

\u00a0 \u00a0– Kar, verimlilik ve pazar pay\u0131nda art\u0131\u015f sa\u011flar.<\/p>

\u00a0 \u00a0–\u00a0<\/strong>\u0130hracatta ve i\u00e7 pazarda \u00fcr\u00fcn\u00fcn m\u00fc\u015fteri taraf\u0131ndan kolayca kabul edilebilirli\u011fini sa\u011flar.<\/p>

\u00a0 \u00a0– \u00dcr\u00fcn\/hizmet g\u00fcvenirlili\u011fini sa\u011flar.<\/p>

\u00a0 \u00a0– Tedarik zincirinde daha iyi bir yer edinmede kolayl\u0131k sa\u011flar.<\/p>

\u00a0<\/p>

ISO 13485: 2016 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi\u00a0Belgesi Nas\u0131l Al\u0131n\u0131r?<\/h3>

\u00a0 \u00a0– Kurulu\u015fun yap\u0131s\u0131 ve sistem ihtiya\u00e7lar\u0131n\u0131n belirlenmesi<\/p>

\u00a0 \u00a0– ISO 13485 standard\u0131na g\u00f6re sistem kurulumu<\/p>

\u00a0 \u00a0– ISO 13485 sisteminin uygulamalar\u0131<\/p>

\u00a0 \u00a0– Akreditasyon kapsamlar\u0131 g\u00f6z \u00f6n\u00fcnde bulundurularak belgelendirme kurulu\u015funa ba\u015fvuru<\/p>

\u00a0 \u00a0– ISO 13485 belgelendirme denetimi ger\u00e7ekle\u015ftirilmesi<\/p>

\u00a0 \u00a0– ISO 13485 belgesinin al\u0131nmas\u0131<\/p>

\u00a0<\/p>

ISO 13485: 2016 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi\u00a0Belgesi Ge\u00e7erlilik S\u00fcresi\u00a0Nedir ve Yenileme S\u00fcreci Nas\u0131ld\u0131r?<\/h3>

ISO 13485 T\u0131bbi Cihazlar Y\u00f6netim Sistemi belgesi al\u0131nd\u0131\u011f\u0131 tarihten itibaren 3 y\u0131l ge\u00e7erlidir. Ancak her y\u0131l g\u00f6zetim denetimleri yap\u0131larak belgenin \u015fartlar\u0131n\u0131n devam etti\u011fi kontrol edilmelidir.<\/p>

\u00a0<\/p>

3 y\u0131l sonunda ISO 13485 belge ge\u00e7erlilik s\u00fcresinin sona ermesiyle yeniden belgelendirme yap\u0131lmas\u0131 i\u00e7in belgelendirme kurulu\u015funa ba\u015fvuru yap\u0131lmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Dan\u0131\u015fmanl\u0131kDevlet Destekleri ve Te\u015fviklerYat\u0131r\u0131m Te\u015fvik Belgesi KOSGEB Destekleri Ticaret Bakanl\u0131\u011f\u0131 Destekleri T\u00dcB\u0130TAK Destekleri Sanayi ve Teknoloji Bakanl\u0131\u011f\u0131 Destekleri SGK Te\u015fvikleri Kalk\u0131nma Ajanslar\u0131 Te\u015fvikleri \u0130\u015eKUR Destekleri Avrupa Birli\u011fi Hibe ve Te\u015fvik Programlar\u0131IPARD Projeleri K\u0131rsal Kalk\u0131nma Projeleri Kalite Belgelendirme ISO 9001: 2015 ISO 14001:2015 ISO 22000:2018 ISO 45001:2018ISO 27001:2013 ISO 10002:2018 ISO 13485:2016 ISO 20000-1:2011 ISO 22301:2019 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1000,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1019","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/pages\/1019","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/comments?post=1019"}],"version-history":[{"count":6,"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/pages\/1019\/revisions"}],"predecessor-version":[{"id":1447,"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/pages\/1019\/revisions\/1447"}],"up":[{"embeddable":true,"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/pages\/1000"}],"wp:attachment":[{"href":"https:\/\/sanbirgrup.com\/birincidanismanlik\/wp-json\/wp\/v2\/media?parent=1019"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}