ISO 13485 Belgesi, t\u0131bbi cihaz \u00fcreticileri, tedarik\u00e7ileri ve ilgili hizmet sa\u011flay\u0131c\u0131lar\u0131n\u0131n kalite y\u00f6netim sistemlerini t\u0131bbi cihaz sekt\u00f6r\u00fcne \u00f6zel gerekliliklere uygun \u015fekilde kurdu\u011funu g\u00f6steren uluslararas\u0131 bir belgedir. Medikal cihaz \u00fcretimi, medikal sarf malzeme, steril \u00fcr\u00fcnler, teknik servis, tasar\u0131m, geli\u015ftirme, depolama ve da\u011f\u0131t\u0131m s\u00fcre\u00e7lerinde faaliyet g\u00f6steren firmalar i\u00e7in ISO 13485 Kalite Y\u00f6netim Sistemi b\u00fcy\u00fck \u00f6nem ta\u015f\u0131r.<\/p>\n\n\n\n
ISO 13485 belgesi almak isteyen i\u015fletmelerin \u00fcr\u00fcn g\u00fcvenli\u011fi, izlenebilirlik, risk y\u00f6netimi, tedarik\u00e7i kontrol\u00fc, \u00fcretim s\u00fcre\u00e7leri, validasyon, sterilizasyon, m\u00fc\u015fteri geri bildirimleri ve yasal gereklilikleri sistemli \u015fekilde y\u00f6netmesi gerekir. Bu standart, klasik kalite y\u00f6netimi yakla\u015f\u0131m\u0131n\u0131n \u00f6tesinde, t\u0131bbi cihazlar\u0131n g\u00fcvenli, etkin ve mevzuata uygun \u015fekilde piyasaya sunulmas\u0131n\u0131 destekleyen \u00f6zel bir sistem yap\u0131s\u0131 olu\u015fturur.<\/p>\n\n\n\n
TADEM olarak ISO 13485 Belgesi s\u00fcrecinde i\u015fletmenizin mevcut kalite altyap\u0131s\u0131n\u0131 analiz ediyor, t\u0131bbi cihaz sekt\u00f6r\u00fcne uygun dok\u00fcmantasyon, prosed\u00fcr, talimat, form ve kay\u0131t sistemlerinin olu\u015fturulmas\u0131na destek sa\u011fl\u0131yoruz. Risk y\u00f6netimi, \u00fcr\u00fcn izlenebilirli\u011fi, tedarik\u00e7i de\u011ferlendirme, uygunsuz \u00fcr\u00fcn kontrol\u00fc, d\u00fczeltici faaliyet, i\u00e7 denetim ve y\u00f6netimin g\u00f6zden ge\u00e7irmesi gibi s\u00fcre\u00e7ler firman\u0131z\u0131n faaliyet alan\u0131na g\u00f6re yap\u0131land\u0131r\u0131l\u0131r.<\/p>\n\n\n\n
ISO 13485 T\u0131bbi Cihazlar \u0130\u00e7in Kalite Y\u00f6netim Sistemi; medikal sekt\u00f6rde g\u00fcvenilirlik sa\u011flamak, m\u00fc\u015fteri ve mevzuat beklentilerini kar\u015f\u0131lamak, ihracat s\u00fcre\u00e7lerini desteklemek ve kurumsal kalite altyap\u0131s\u0131n\u0131 g\u00fc\u00e7lendirmek isteyen i\u015fletmeler i\u00e7in stratejik bir belgedir. TADEM, ISO 13485 Belgesi s\u00fcrecini yaln\u0131zca belge alma \u00e7al\u0131\u015fmas\u0131 olarak de\u011fil, medikal \u00fcretim ve hizmet s\u00fcre\u00e7lerini g\u00fcvence alt\u0131na alan uygulanabilir bir sistem kurulumu olarak ele al\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"
ISO 13485 Belgesi \u2013 T\u0131bbi Cihazlar \u0130\u00e7in Kalite Y\u00f6netim Sistemi ISO 13485 Belgesi, t\u0131bbi cihaz \u00fcreticileri, tedarik\u00e7ileri ve ilgili hizmet sa\u011flay\u0131c\u0131lar\u0131n\u0131n kalite y\u00f6netim sistemlerini t\u0131bbi cihaz sekt\u00f6r\u00fcne \u00f6zel gerekliliklere uygun…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-205","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/posts\/205","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=205"}],"version-history":[{"count":1,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/posts\/205\/revisions"}],"predecessor-version":[{"id":206,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=\/wp\/v2\/posts\/205\/revisions\/206"}],"wp:attachment":[{"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=205"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=205"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tademmuhendislik.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=205"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}