{"id":9421,"date":"2025-10-10T11:55:25","date_gmt":"2025-10-10T11:55:25","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9421"},"modified":"2025-10-10T11:55:31","modified_gmt":"2025-10-10T11:55:31","slug":"iso-134852016-gereksinimleri-ve-uygulamada-dikkat-edilmesi-gerekenler","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/iso-134852016-gereksinimleri-ve-uygulamada-dikkat-edilmesi-gerekenler\/","title":{"rendered":"ISO 13485:2016 Gereksinimleri ve Uygulamada Dikkat Edilmesi Gerekenler"},"content":{"rendered":"<h3 class=\"wp-block-heading\">Giri\u015f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">T\u0131bbi cihaz sekt\u00f6r\u00fcnde kalite y\u00f6netim sistemi denince akla ilk gelen standartlardan biri <strong>ISO 13485:2016<\/strong>\u2019d\u0131r.<br>Bu standart, t\u0131bbi cihaz \u00fcreticilerinin <strong>\u00fcr\u00fcn g\u00fcvenli\u011fi, risk y\u00f6netimi<\/strong> ve <strong>reg\u00fclasyon uyumu<\/strong> a\u00e7\u0131s\u0131ndan sistematik bir yap\u0131 kurmas\u0131n\u0131 sa\u011flar.<br>T\u00fcm \u00fcretim s\u00fcre\u00e7lerinin, tasar\u0131mdan son kullan\u0131c\u0131ya kadar <strong>izlenebilir<\/strong> ve <strong>kontrol alt\u0131nda<\/strong> y\u00fcr\u00fct\u00fclmesini hedefler.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 ISO 13485:2016 Nedir?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>ISO 13485<\/strong>, t\u0131bbi cihazlar ve ilgili hizmetler i\u00e7in \u00f6zel olarak tasarlanm\u0131\u015f bir kalite y\u00f6netim standard\u0131d\u0131r.<br>2016 versiyonu, risk temelli yakla\u015f\u0131m\u0131 g\u00fc\u00e7lendirerek, <strong>\u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fcn her a\u015famas\u0131nda kalite g\u00fcvencesini<\/strong> \u00f6n plana \u00e7\u0131karm\u0131\u015ft\u0131r.<br>Ayr\u0131ca, <strong>MDR (2017\/745)<\/strong> ve <strong>IVDR (2017\/746)<\/strong> d\u00fczenlemeleriyle de uyumlu bir temel olu\u015fturur.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 ISO 13485:2016\u2019daki \u00d6nemli G\u00fcncellemeler<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Yeni versiyon, \u00f6nceki versiyonlara g\u00f6re pek \u00e7ok yenilik getirdi. Bunlar\u0131n ba\u015fl\u0131calar\u0131 \u015funlard\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Risk temelli d\u00fc\u015f\u00fcnme<\/strong> art\u0131k t\u00fcm s\u00fcre\u00e7lerde zorunlu hale geldi.<\/li>\n\n\n\n<li><strong>Dok\u00fcmantasyon yap\u0131s\u0131<\/strong> sadele\u015ftirildi ancak izlenebilirlik gereksinimleri artt\u0131.<\/li>\n\n\n\n<li><strong>D\u0131\u015f tedarik y\u00f6netimi<\/strong> (outsourcing) daha s\u0131k\u0131 kontrol alt\u0131na al\u0131nd\u0131.<\/li>\n\n\n\n<li><strong>Reg\u00fclasyon gereksinimleriyle entegrasyon<\/strong> vurgusu g\u00fc\u00e7lendirildi.<\/li>\n\n\n\n<li><strong>Yaz\u0131l\u0131m validasyonu<\/strong> ve <strong>veri b\u00fct\u00fcnl\u00fc\u011f\u00fc<\/strong> konular\u0131nda ek detaylar getirildi.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 ISO 13485:2016\u2019n\u0131n Ana Gereksinim Ba\u015fl\u0131klar\u0131<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Kalite Y\u00f6netim Sistemi (QMS)<\/strong>: S\u00fcre\u00e7lerin planlanmas\u0131, uygulanmas\u0131, \u00f6l\u00e7\u00fclmesi ve iyile\u015ftirilmesi.<\/li>\n\n\n\n<li><strong>Y\u00f6netim Sorumlulu\u011fu<\/strong>: \u00dcst y\u00f6netimin taahh\u00fcd\u00fc, kalite politikas\u0131 ve hedefleri.<\/li>\n\n\n\n<li><strong>Kaynak Y\u00f6netimi<\/strong>: \u0130nsan kayna\u011f\u0131, altyap\u0131 ve \u00e7al\u0131\u015fma ortam\u0131 gereklilikleri.<\/li>\n\n\n\n<li><strong>\u00dcr\u00fcn Ger\u00e7ekle\u015ftirme<\/strong>: Tasar\u0131m, \u00fcretim, do\u011frulama ve sevkiyat dahil t\u00fcm s\u00fcre\u00e7ler.<\/li>\n\n\n\n<li><strong>\u00d6l\u00e7me, Analiz ve \u0130yile\u015ftirme<\/strong>: Performans g\u00f6stergeleri, i\u00e7 denetimler, d\u00fczeltici ve \u00f6nleyici faaliyetler.<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 Risk Tabanl\u0131 Yakla\u015f\u0131m\u0131n \u00d6nemi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485:2016\u2019n\u0131n en temel felsefesi <strong>risk y\u00f6netimi<\/strong>dir.<br>Tasar\u0131m a\u015famas\u0131ndan \u00fcretime, hatta da\u011f\u0131t\u0131m ve geri bildirim s\u00fcre\u00e7lerine kadar t\u00fcm a\u015famalarda risklerin <strong>tan\u0131mlanmas\u0131, de\u011ferlendirilmesi ve kontrol alt\u0131na al\u0131nmas\u0131<\/strong> gerekir.<br>Bu, <strong>ISO 14971<\/strong> (T\u0131bbi Cihaz Risk Y\u00f6netimi) standard\u0131yla da do\u011frudan ba\u011flant\u0131l\u0131d\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 \u0130\u00e7 Denetim ve Y\u00f6netim G\u00f6zden Ge\u00e7irme<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Sistemin etkinli\u011fini s\u00fcrd\u00fcrebilmesi i\u00e7in d\u00fczenli <strong>i\u00e7 denetimlerin<\/strong> yap\u0131lmas\u0131 \u015fartt\u0131r.<br>Denetim bulgular\u0131, d\u00fczeltici faaliyet planlar\u0131yla desteklenmeli ve y\u00f6netim g\u00f6zden ge\u00e7irme toplant\u0131lar\u0131nda sistematik olarak de\u011ferlendirilmeli.<br>Bu ad\u0131m, belgelendirme s\u00fcrecinde denet\u00e7ilerin \u00f6zellikle odakland\u0131\u011f\u0131 alanlardan biridir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 ISO 13485 Sertifikasyon S\u00fcreci<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Mevcut durum analizi (gap analizi)<\/li>\n\n\n\n<li>Kalite y\u00f6netim sistemi kurulumu \/ revizyonu<\/li>\n\n\n\n<li>Dok\u00fcmantasyon olu\u015fturma<\/li>\n\n\n\n<li>Uygulama &amp; kay\u0131tlar\u0131n tutulmas\u0131<\/li>\n\n\n\n<li>\u0130\u00e7 denetim ve y\u00f6netim g\u00f6zden ge\u00e7irme<\/li>\n\n\n\n<li>Belgelendirme kurulu\u015fu denetimi<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Sertifika ge\u00e7erlilik s\u00fcresi genellikle 3 y\u0131ld\u0131r, ancak her y\u0131l g\u00f6zetim denetimleri yap\u0131l\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 Uyum S\u00fcrecinde Yayg\u0131n Hatalar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dok\u00fcmantasyonun g\u00fcncel tutulmamas\u0131<\/li>\n\n\n\n<li>Risk de\u011ferlendirme kay\u0131tlar\u0131n\u0131n eksikli\u011fi<\/li>\n\n\n\n<li>D\u0131\u015f tedarik\u00e7i performans\u0131n\u0131n izlenmemesi<\/li>\n\n\n\n<li>E\u011fitim kay\u0131tlar\u0131n\u0131n eksikli\u011fi<\/li>\n\n\n\n<li>CAPA s\u00fcre\u00e7lerinin zay\u0131f olmas\u0131<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu hatalar\u0131n \u00e7o\u011fu, sistematik bir i\u00e7 denetim mekanizmas\u0131yla \u00f6nlenebilir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 ISO 13485 ve Global Uyum<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485:2016, <strong>FDA QMSR (Quality Management System Regulation)<\/strong> ve <strong>21 CFR Part 820<\/strong> ile b\u00fcy\u00fck \u00f6l\u00e7\u00fcde uyumlu hale gelmi\u015ftir.<br>Bu sayede \u00fcreticiler hem Avrupa hem de ABD pazar\u0131na a\u00e7\u0131lmada ortak bir kalite \u00e7er\u00e7evesi kullanabilir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udd39 Sonu\u00e7<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485:2016, t\u0131bbi cihaz \u00fcreticileri i\u00e7in yaln\u0131zca bir gereklilik de\u011fil, <strong>s\u00fcrd\u00fcr\u00fclebilir kalite k\u00fclt\u00fcr\u00fcn\u00fcn temeli<\/strong>dir.<br>Bu standarda uygun bir sistem, hem <strong>reg\u00fclasyon otoriteleriyle uyumu<\/strong> hem de <strong>m\u00fc\u015fteri g\u00fcvenini<\/strong> art\u0131r\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udccc <strong>Kalitekit<\/strong>, ISO 13485 standard\u0131na uyum s\u00fcrecinde firmalara dan\u0131\u015fmanl\u0131k, dok\u00fcmantasyon geli\u015ftirme ve i\u00e7 denetim deste\u011fi sa\u011flamaktad\u0131r.<br>Yeni d\u00fczenlemelere uygun, izlenebilir ve denetime haz\u0131r bir sistem kurmak i\u00e7in bizimle ileti\u015fime ge\u00e7ebilirsiniz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">#Kalitekit #ISO13485 #T\u0131bbiCihaz #KaliteY\u00f6netimSistemi #RiskY\u00f6netimi #MedicalDevices #RegulatoryCompliance<\/p>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihaz sekt\u00f6r\u00fcnde kalite y\u00f6netim sistemi denince akla ilk gelen standartlardan biri ISO 13485:2016\u2019d\u0131r.<br \/>\nBu standart, t\u0131bbi cihaz \u00fcreticilerinin \u00fcr\u00fcn g\u00fcvenli\u011fi, risk y\u00f6netimi ve reg\u00fclasyon uyumu a\u00e7\u0131s\u0131ndan sistematik bir yap\u0131 kurmas\u0131n\u0131 sa\u011flar.<br \/>\nT\u00fcm \u00fcretim s\u00fcre\u00e7lerinin, tasar\u0131mdan son kullan\u0131c\u0131ya kadar izlenebilir ve kontrol alt\u0131nda y\u00fcr\u00fct\u00fclmesini hedefler.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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