{"id":7458,"date":"2020-04-29T04:55:29","date_gmt":"2020-04-29T01:55:29","guid":{"rendered":"https:\/\/northakademi.com\/tr\/?page_id=7458"},"modified":"2020-04-29T04:58:17","modified_gmt":"2020-04-29T01:58:17","slug":"iso-13485-tibbi-cihazlar-kalite-yonetim-sistemi","status":"publish","type":"page","link":"https:\/\/northakademi.com\/tr\/belgelendirme\/sistem-belgelendirme\/iso-13485-tibbi-cihazlar-kalite-yonetim-sistemi\/","title":{"rendered":"ISO 13485 T\u0131bbi Cihazlar Kalite Y\u00f6netim Sistemi"},"content":{"rendered":"<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_1' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   av-minimum-height av-minimum-height-custom container_wrap sidebar_right' style = 'background-repeat: no-repeat; background-image: url(https:\/\/northakademi.com\/tr\/wp-content\/uploads\/2019\/12\/slide-north-akademi-siyah-lacivert.jpg); background-attachment: scroll; background-position: top left; ' data-section-bg-repeat='no-repeat' ><div class='container' style='height:150px'><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-7458'><div class='entry-content-wrapper clearfix'>\n<div style='padding-bottom:10px;color:#ffffff;' class='av-special-heading av-special-heading-h3 custom-color-heading   '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >ISO 13485 T\u0131bbi Cihazlar Kalite Y\u00f6netim Sistemi<\/h3><div class='special-heading-border'><div class='special-heading-inner-border' style='border-color:#ffffff'><\/div><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-7458'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_full  flex_column_div av-zero-column-padding first  \" style='border-radius:0px; '><p><div class='avia-image-container  av-styling-    avia-align-center '  itemprop=\"ImageObject\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"  ><div class='avia-image-container-inner'><img class='avia_image ' src='https:\/\/northakademi.com\/tr\/wp-content\/uploads\/2020\/04\/belge-iso-genel-s.jpg' alt='' title=''   itemprop=\"thumbnailUrl\"  \/><\/div><\/div><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><p>Kalite Y\u00f6netim Sistem standard\u0131n\u0131n t\u0131bbi medikal cihazlara uyarlanm\u0131\u015f ve bu kapsamda geli\u015ftirilmi\u015f versiyonudur. T\u0131bbi cihazlar i\u00e7in \u00f6zel \u015fartlar bar\u0131nd\u0131ran uluslararas\u0131 bir standart niteli\u011findedir.<\/p>\n<p>Temel olarak ISO 9001:2015 Kalite Y\u00f6netim Sistemi\u2019ne benzemekle birlikte \u00f6zellikle tasar\u0131m a\u015famas\u0131ndaki ek talepleri ve istekleri ile birlikte, steril t\u0131bbi cihazlar ve v\u00fccuda yerle\u015ftirilebilir (implante edilebilen) t\u0131bbi cihazlara \u00f6zel durumlarda t\u0131bbi cihaz \u00fcreticilerine ait \u00f6zel bir standart haline getirilmi\u015ftir.<\/p>\n<p>ISO 13485:2012 Medikal Kalite Y\u00f6netim Sistemi, t\u0131bbi cihaz \u00fcreticilerinin CE markalama ya da i\u015faretleme \u00e7al\u0131\u015fmas\u0131 yapabilmek i\u00e7in de kullanabilecekleri en \u00f6nemli kaynak arg\u00fcmanlardan biridir. CE i\u015faretlemesi kapsam\u0131nda \u00fcretici taraf\u0131ndan, \u00fcretim kalite g\u00fcvencesi mod\u00fcl\u00fcn\u00fcn tercih edilmesi halinde firmalar\u0131n uygulamas\u0131 gerekli olan bir y\u00f6netim sistemdir.<\/p>\n<p>ISO 9001:2015 temel i\u015flemler yakla\u015f\u0131m\u0131 modelini esas alan bu standart, t\u0131bbi cihazlar ve ilgili servisleri sa\u011flamak, tutarl\u0131 bir bi\u00e7imde t\u0131bbi cihazlara uygulanabilir olan m\u00fc\u015fteri ve mevzuat \u015fartlar\u0131n\u0131 kar\u015f\u0131layabilme yetene\u011fini ispatlamak isteyen kurulu\u015flar\u0131n uymalar\u0131 gereken ve ISO 9001:2015 den daha kapsaml\u0131 ve \u00f6zel bir kalite sistem \u015fartlar\u0131n\u0131 kapsar.<br \/>\nT\u0131bbi cihazlar\u0131n ticareti ve imalat\u0131 alan\u0131nda faaliyetlerini s\u00fcrd\u00fcren firmalara y\u00f6nelik kalite y\u00f6netim sistemleri sa\u011flamas\u0131 gereken \u00f6zel \u015fartlar\u0131 tan\u0131mlayan bir standart olan ISO 13485:2012, t\u0131bbi cihazlar\u0131n veya onlar ile ilgili hizmetlerin proje, \u00fcretim, tesisat ve tedarik s\u00fcre\u00e7lerini de i\u00e7ine alan b\u00fct\u00fcn kurulu\u015flar taraf\u0131ndan uygulanabilmektedir.<br \/>\nISO 13485:2012 Standard\u0131n\u0131 Kimler Uygulayabilir?<br \/>\nT\u0131bbi cihaz kapsam\u0131ndaki b\u00fct\u00fcn \u00fcr\u00fcnlerin \u00fcretiminde ve servis faaliyetleri alan\u0131nda \u00e7al\u0131\u015fmalar\u0131n\u0131 devam ettiren b\u00fct\u00fcn kurum ve kurulu\u015flara uygulanabilmektedir.<\/p>\n<p>Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 uyar\u0131nca, \u00fcr\u00fcn s\u0131n\u0131flar\u0131 hangi s\u0131n\u0131fta olursa olsun t\u0131bbi cihaz \u00fcreticileri ISO 13485:2012 sertifikas\u0131na sahip olmak durumundad\u0131r.<br \/>\nISO 13485:2012 T\u0131bbi Cihazlar \u0130\u00e7in Kalite Y\u00f6netim Sisteminin Faydalar\u0131<br \/>\nE\u011fitime, devaml\u0131 iyile\u015ftirmeye ve geli\u015fmeye imkan sa\u011flar.<br \/>\nFirmalarda kalite fark\u0131ndal\u0131\u011f\u0131n\u0131n art\u0131r\u0131lmas\u0131 i\u00e7in en \u00f6nemli ara\u00e7lardan biridir.<\/p>\n<p>T\u0131bbi cihazlar\u0131n risk gruplar\u0131n\u0131n tespit edilmesinde bir k\u0131lavuzdur.<br \/>\nAvrupa Birli\u011fi ve di\u011fer \u00fclkelere yap\u0131lan ihracatta ortak bir dildir.<br \/>\nYasa, mevzuat ve y\u00f6netmeliklere uyum sa\u011flanmas\u0131n\u0131 kolayla\u015ft\u0131r\u0131r.<\/p>\n<\/div><\/section><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":6259,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/pages\/7458"}],"collection":[{"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/comments?post=7458"}],"version-history":[{"count":2,"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/pages\/7458\/revisions"}],"predecessor-version":[{"id":7460,"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/pages\/7458\/revisions\/7460"}],"up":[{"embeddable":true,"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/pages\/6259"}],"wp:attachment":[{"href":"https:\/\/northakademi.com\/tr\/wp-json\/wp\/v2\/media?parent=7458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}