{"id":1923,"date":"2019-05-22T07:56:47","date_gmt":"2019-05-22T07:56:47","guid":{"rendered":"http:\/\/icrpolska.e-ksperci.pl\/?page_id=1923"},"modified":"2022-09-07T22:58:41","modified_gmt":"2022-09-07T20:58:41","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/icrturkey.com\/tr\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>ISO 13485 nedir?<\/h4>\n<p>Uluslararas\u0131 ISO 13485 standard\u0131 'T\u0131bbi cihazlar - Kalite y\u00f6netim sistemleri - D\u00fczenleyici ama\u00e7lar i\u00e7in gereklilikler' t\u0131bbi cihazlar\u0131n \u00fcretimi i\u00e7in kalite y\u00f6netim sistemleri ile ilgilidir. \u00dcretim d\u00f6ng\u00fcs\u00fc boyunca bir kurulu\u015f taraf\u0131ndan kar\u015f\u0131lanmas\u0131 gereken bir kalite y\u00f6netim sistemi i\u00e7in gereklilikleri tan\u0131mlar. ISO 13485'in gereklilikleri, b\u00fcy\u00fckl\u00fc\u011f\u00fc veya t\u00fcr\u00fc ne olursa olsun t\u00fcm kurulu\u015flar i\u00e7in ge\u00e7erlidir.<\/p>\n<h4>Standard\u0131n kapsam\u0131:<\/h4>\n<p>ISO 13485, bir kurulu\u015fun t\u0131bbi cihazlar ve ilgili hizmetleri sa\u011flama, m\u00fc\u015fteri ve ge\u00e7erli mevzuat gerekliliklerini s\u00fcrekli olarak kar\u015f\u0131lama becerisini g\u00f6stermesi gerekti\u011finde KYS gerekliliklerini i\u00e7erir. Bu t\u00fcr kurulu\u015flar, bir t\u0131bbi cihaz\u0131n tasar\u0131m\u0131 ve geli\u015ftirilmesi, \u00fcretimi, depolanmas\u0131 ve da\u011f\u0131t\u0131m\u0131, kurulumu veya servisi ve ilgili hizmetlerin tasar\u0131m\u0131 ve geli\u015ftirilmesi veya sa\u011flanmas\u0131 (\u00f6rne\u011fin: teknik destek) dahil olmak \u00fczere \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fcn bir veya daha fazla a\u015famas\u0131na dahil olabilir.<\/p>\n<p>Bu standart, KYS ile ilgili hizmetler de dahil olmak \u00fczere, b\u00f6yle bir kurulu\u015fa \u00fcr\u00fcn tedarik eden tedarik\u00e7iler veya harici taraflarca da kullan\u0131labilir.<\/p>\n<h4>Genel gereklilikler:<\/h4>\n<p>Her kurulu\u015f a\u015fa\u011f\u0131daki gereklilikleri sa\u011flamal\u0131d\u0131r:<\/p>\n<ul>\n<li>Kalite y\u00f6netim sistemini dok\u00fcmante edin ve etkinli\u011fini s\u00fcrd\u00fcr\u00fcn,<\/li>\n<li>Standartta yer alan t\u00fcm gereklilikleri, prosed\u00fcrleri ve faaliyetleri olu\u015fturun, uygulay\u0131n ve s\u00fcrd\u00fcr\u00fcn,<\/li>\n<li>KYS'de ihtiya\u00e7 duyulan s\u00fcre\u00e7leri ve bunlar\u0131n kurulu\u015ftaki uygulamalar\u0131n\u0131 tan\u0131mlamak,<\/li>\n<li>\u0130lgili s\u00fcre\u00e7leri denetlemek i\u00e7in risk temelli bir yakla\u015f\u0131m kullan\u0131n,<\/li>\n<li>Bu s\u00fcre\u00e7lerin s\u0131ras\u0131n\u0131 ve etkile\u015fimlerini tan\u0131mlay\u0131n,<\/li>\n<li>Bu s\u00fcre\u00e7leri uygun \u015fekilde y\u00f6netin,<\/li>\n<li>KYS'de kullan\u0131lan bilgisayar yaz\u0131l\u0131mlar\u0131n\u0131n kullan\u0131m\u0131n\u0131 do\u011frulama prosed\u00fcrlerini dok\u00fcmante edin,<\/li>\n<\/ul>\n<h4>ISO 13485'in Faydalar\u0131:<\/h4>\n<ul>\n<li>\u015eirketin g\u00fcvenilirli\u011fini artt\u0131rmak,<\/li>\n<li>\u0130\u00e7 ve d\u0131\u015f pazarlara eri\u015fim sa\u011flamak,<\/li>\n<li>Kurumun rekabet g\u00fcc\u00fcn\u00fc art\u0131rmak,<\/li>\n<li>Kurumun s\u00fcre\u00e7leri daha \u015feffaf hale getirmek,<\/li>\n<li>Kusurlu \u00fcr\u00fcn riskini en aza indirmek,<\/li>\n<li>\u015eikayet say\u0131s\u0131n\u0131 azaltmak.<\/li>\n<\/ul>\n<h4>Kimler ISO 13485 sertifikas\u0131na sahip olmal\u0131d\u0131r?<\/h4>\n<p>ISO 13485'e g\u00f6re kalite y\u00f6netim sistemi, t\u0131bbi cihaz \u00fcreticileri ve t\u0131bbi cihaz i\u015finde yer alan di\u011fer \u015firketler (\u00f6rne\u011fin: t\u0131bbi ekipman hizmeti sa\u011flayan \u015firketler) taraf\u0131ndan uygulanmaktad\u0131r.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; ISO 13485 nedir? Uluslararas\u0131 ISO 13485 standard\u0131 'T\u0131bbi cihazlar - Kalite y\u00f6netim sistemleri - D\u00fczenleyici ama\u00e7lar i\u00e7in gereklilikler' t\u0131bbi cihazlar\u0131n \u00fcretimi i\u00e7in kalite y\u00f6netim sistemleri ile ilgilidir. \u00dcretim d\u00f6ng\u00fcs\u00fc boyunca bir kurulu\u015f taraf\u0131ndan kar\u015f\u0131lanmas\u0131 gereken bir kalite y\u00f6netim sistemi i\u00e7in gereklilikleri tan\u0131mlar. ISO 13485'in gereklilikleri kurulu\u015flara bak\u0131lmaks\u0131z\u0131n uygulan\u0131r...&nbsp;<a href=\"https:\/\/icrturkey.com\/tr\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">Daha fazlas\u0131n\u0131 oku \"<span class=\"screen-reader-text\">ISO 13485<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":1063,"parent":162,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"off","neve_meta_content_width":70,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","footnotes":""},"class_list":["post-1923","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - ICR TURKEY - tests and certification<\/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:\/\/icrturkey.com\/tr\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - ICR TURKEY - tests and certification\" \/>\n<meta property=\"og:description\" content=\"&nbsp; Czym jest ISO 13485? 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