{"id":8507,"date":"2024-08-22T14:44:04","date_gmt":"2024-08-22T14:44:04","guid":{"rendered":"https:\/\/certifiqat.com\/news\/iso-13485-quality-management-system-for-medical-devices\/"},"modified":"2024-08-23T12:08:03","modified_gmt":"2024-08-23T12:08:03","slug":"iso-13485-quality-management-system-for-medical-devices","status":"publish","type":"post","link":"https:\/\/certifiqat.com\/tr\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; T\u0131bbi Cihazlar i\u00e7in Kalite Y\u00f6netim Sistemi"},"content":{"rendered":"\n<p><strong>Uluslararas\u0131 ISO 13485 standard\u0131, t\u0131bbi cihaz \u00fcreten veya da\u011f\u0131tan ya da tedarik zincirinin bir par\u00e7as\u0131 olarak bunlar\u0131n \u00fcretiminde yer alan \u015firketlerde kalite y\u00f6netim sistemlerinin belgelendirilmesi i\u00e7in temel te\u015fkil etmektedir.<\/strong><\/p>\n\n\n\n<p>Bir kalite y\u00f6netim sistemi, t\u0131bbi cihaz \u00fcreticileri i\u00e7in operasyonlar\u0131n ve g\u00f6revlerin bel kemi\u011fini olu\u015fturur. Hem i\u00e7 hem de d\u0131\u015f d\u00fczenlemelerin g\u00fcvenilir bir \u015fekilde takip edilmesini sa\u011flar.<\/p>\n\n\n\n<p>\u00dcreticiler, sistemlerini uygun \u015fekilde belgelendirerek s\u00fcre\u00e7lerine ve \u00fcr\u00fcnlerine g\u00fcven olu\u015fturabilir ve g\u00fcvenlik ve kaliteye olan ba\u011fl\u0131l\u0131klar\u0131n\u0131 g\u00f6sterebilirler.<\/p>\n\n\n\n<p>Standart, t\u0131bbi cihaz \u00fcreticilerinin ve tedarik\u00e7ilerinin t\u0131bbi teknoloji end\u00fcstrisi i\u00e7in y\u00f6netim sistemleri geli\u015ftirirken, uygularken ve s\u00fcrd\u00fcr\u00fcrken kar\u015f\u0131lamalar\u0131 gereken gereklilikleri ele al\u0131r.<\/p>\n\n\n\n<p>Avantajlar:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Belgelenmi\u015f prosed\u00fcrler arac\u0131l\u0131\u011f\u0131yla s\u00fcre\u00e7 g\u00fcvenli\u011fi <\/strong><\/li>\n\n\n\n<li><strong>Yasal gerekliliklere uygunluk kan\u0131t\u0131 <\/strong><\/li>\n\n\n\n<li><strong>Hastalar ve kullan\u0131c\u0131lar i\u00e7in daha fazla \u00fcr\u00fcn g\u00fcvenli\u011fi <\/strong><\/li>\n\n\n\n<li><strong>M\u00fc\u015fteriler ve \u00e7al\u0131\u015fanlar aras\u0131nda artan memnuniyet <\/strong><\/li>\n\n\n\n<li><strong>\u015eirketin yetkinli\u011finin vurgulanmas\u0131<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 13485 nedir?<\/h2>\n\n\n\n<p>ISO 13485, t\u0131bbi cihaz veya in vitro diagnostik \u00fcreticileri i\u00e7in kalite y\u00f6netim sistemlerine y\u00f6nelik ba\u011f\u0131ms\u0131z bir standartt\u0131r. Uluslararas\u0131 alanda tan\u0131nan ve kabul g\u00f6ren EN ISO 9000 standart serisinden kaynaklanmaktad\u0131r. ISO 13485, ISO 9001&#8217;in s\u00fcre\u00e7 odakl\u0131 yakla\u015f\u0131m\u0131n\u0131 s\u00fcrd\u00fcr\u00fcr ve bunu t\u0131bbi cihaz veya in vitro tan\u0131 \u00fcreticileri i\u00e7in \u00f6zellikle \u00f6nemli olan belirli y\u00f6nlerle tamamlar.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 13485 neleri i\u00e7erir?<\/h2>\n\n\n\n<p>ISO 13485, \u00fcreticileri g\u00fcvenli ve etkili s\u00fcre\u00e7ler sa\u011flayan bir kalite y\u00f6netim sistemi geli\u015ftirmeleri konusunda destekler. Bu s\u00fcre\u00e7ler, t\u0131bbi cihazlar\u0131n t\u00fcm \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc kapsayan tutarl\u0131 tasar\u0131m, geli\u015ftirme, \u00fcretim, kurulum, teslimat, izleme, takip ve bertaraf\u0131n\u0131 sa\u011flamak \u00fczere tasarlanm\u0131\u015ft\u0131r. Bu, t\u0131bbi cihazlar\u0131n ve in vitro diagnostiklerin ama\u00e7lar\u0131na uygun olarak g\u00fcvenli bir \u015fekilde kullan\u0131labilmesini sa\u011flamak i\u00e7indir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 13485&#8217;in yasal \u00f6nemi nedir?<\/h2>\n\n\n\n<p>T\u0131bbi cihazlar veya in vitro diagnostikler i\u00e7in d\u00fczenleyici onay programlar\u0131 genellikle ISO 13485 gerekliliklerine dayan\u0131r. ISO 13485&#8217;teki genel gereklilikler, somutla\u015ft\u0131rmalar ve eklemeler yoluyla geni\u015fletilir ve belirli yasal pazar gerekliliklerine uyarlan\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 13485 ve EN ISO 13485 aras\u0131ndaki fark nedir?<\/h2>\n\n\n\n<p>ISO 13485 standard\u0131n uluslararas\u0131 kabul g\u00f6rm\u00fc\u015f temel versiyonudur, ancak Avrupa d\u00fczenleyici onay prosed\u00fcrlerinde dikkate al\u0131nmak \u00fczere Avrupa standardizasyon kurulu\u015fu taraf\u0131ndan bir Avrupa standard\u0131 haline getirilmi\u015ftir. Uyumla\u015ft\u0131r\u0131lm\u0131\u015f bir standard\u0131 takip ederek bir \u00fcretici, \u00fcr\u00fcnlerinin veya hizmetlerinin ilgili AB mevzuat\u0131n\u0131n teknik gerekliliklerini kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 kan\u0131tlayabilir ve gerekirse s\u00f6zde uygunluk karinesini de ileri s\u00fcrebilir.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Uluslararas\u0131 ISO 13485 standard\u0131, t\u0131bbi cihaz \u00fcreten veya da\u011f\u0131tan ya da tedarik zincirinin bir par\u00e7as\u0131 olarak bunlar\u0131n \u00fcretiminde yer alan \u015firketlerde kalite y\u00f6netim sistemlerinin belgelendirilmesi i\u00e7in temel te\u015fkil etmektedir. Bir kalite y\u00f6netim sistemi, t\u0131bbi cihaz \u00fcreticileri i\u00e7in operasyonlar\u0131n ve g\u00f6revlerin bel kemi\u011fini olu\u015fturur. Hem i\u00e7 hem de d\u0131\u015f d\u00fczenlemelerin g\u00fcvenilir bir \u015fekilde takip edilmesini sa\u011flar.<\/p>\n","protected":false},"author":3,"featured_media":8492,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19411,19471],"tags":[],"class_list":["post-8507","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-tr","category-standard-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - T\u0131bbi Cihazlar i\u00e7in Kalite Y\u00f6netim Sistemi - Certifiqat.com<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/certifiqat.com\/tr\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - T\u0131bbi Cihazlar i\u00e7in Kalite Y\u00f6netim Sistemi - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"Uluslararas\u0131 ISO 13485 standard\u0131, t\u0131bbi cihaz \u00fcreten veya da\u011f\u0131tan ya da tedarik zincirinin bir par\u00e7as\u0131 olarak bunlar\u0131n \u00fcretiminde yer alan \u015firketlerde kalite y\u00f6netim sistemlerinin belgelendirilmesi i\u00e7in temel te\u015fkil etmektedir. Bir kalite y\u00f6netim sistemi, t\u0131bbi cihaz \u00fcreticileri i\u00e7in operasyonlar\u0131n ve g\u00f6revlerin bel kemi\u011fini olu\u015fturur. 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