{"id":8495,"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":"2024-08-23T12:08:00","modified_gmt":"2024-08-23T12:08:00","slug":"iso-13485-quality-management-system-for-medical-devices","status":"publish","type":"post","link":"https:\/\/certifiqat.com\/cs\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; Syst\u00e9m \u0159\u00edzen\u00ed kvality pro zdravotnick\u00e9 prost\u0159edky"},"content":{"rendered":"\n<p><strong>Mezin\u00e1rodn\u00ed norma ISO 13485 slou\u017e\u00ed jako z\u00e1klad pro certifikaci syst\u00e9m\u016f \u0159\u00edzen\u00ed kvality ve spole\u010dnostech, kter\u00e9 vyr\u00e1b\u011bj\u00ed nebo distribuuj\u00ed zdravotnick\u00e9 prost\u0159edky nebo se pod\u00edlej\u00ed na jejich v\u00fdrob\u011b v r\u00e1mci dodavatelsk\u00e9ho \u0159et\u011bzce.<\/strong><\/p>\n\n\n\n<p>Syst\u00e9m \u0159\u00edzen\u00ed kvality tvo\u0159\u00ed p\u00e1te\u0159 \u010dinnost\u00ed a \u00fakol\u016f v\u00fdrobc\u016f zdravotnick\u00fdch prost\u0159edk\u016f. Zaji\u0161\u0165uje spolehliv\u00e9 dodr\u017eov\u00e1n\u00ed intern\u00edch i extern\u00edch p\u0159edpis\u016f.<\/p>\n\n\n\n<p>Vhodnou certifikac\u00ed sv\u00e9ho syst\u00e9mu mohou v\u00fdrobci vybudovat d\u016fv\u011bru ve sv\u00e9 procesy a v\u00fdrobky a prok\u00e1zat sv\u016fj z\u00e1vazek k bezpe\u010dnosti a kvalit\u011b.<\/p>\n\n\n\n<p>Norma se zab\u00fdv\u00e1 po\u017eadavky, kter\u00e9 mus\u00ed v\u00fdrobci a dodavatel\u00e9 zdravotnick\u00fdch prost\u0159edk\u016f spl\u0148ovat p\u0159i v\u00fdvoji, zav\u00e1d\u011bn\u00ed a udr\u017eov\u00e1n\u00ed syst\u00e9m\u016f \u0159\u00edzen\u00ed pro pr\u016fmysl zdravotnick\u00e9 techniky.<\/p>\n\n\n\n<p>V\u00fdhody:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bezpe\u010dnost proces\u016f d\u00edky dokumentovan\u00fdm postup\u016fm <\/strong><\/li>\n\n\n\n<li><strong>D\u016fkaz o spln\u011bn\u00ed z\u00e1konn\u00fdch po\u017eadavk\u016f <\/strong><\/li>\n\n\n\n<li><strong>V\u011bt\u0161\u00ed bezpe\u010dnost v\u00fdrobk\u016f pro pacienty a u\u017eivatele <\/strong><\/li>\n\n\n\n<li><strong>V\u011bt\u0161\u00ed spokojenost z\u00e1kazn\u00edk\u016f a zam\u011bstnanc\u016f <\/strong><\/li>\n\n\n\n<li><strong>Zv\u00fdrazn\u011bn\u00ed kompetenc\u00ed spole\u010dnosti<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Co je ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 je samostatn\u00e1 norma pro syst\u00e9my \u0159\u00edzen\u00ed kvality pro v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f nebo diagnostiky in vitro. Vych\u00e1z\u00ed z mezin\u00e1rodn\u011b uzn\u00e1van\u00e9 a akceptovan\u00e9 \u0159ady norem EN ISO 9000. Norma ISO 13485 navazuje na procesn\u011b orientovan\u00fd p\u0159\u00edstup normy ISO 9001 a dopl\u0148uje jej o specifick\u00e9 aspekty, kter\u00e9 jsou d\u016fle\u017eit\u00e9 zejm\u00e9na pro v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f nebo diagnostiky in vitro.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Co obsahuje norma ISO 13485?<\/h2>\n\n\n\n<p>Norma ISO 13485 podporuje v\u00fdrobce ve v\u00fdvoji syst\u00e9mu \u0159\u00edzen\u00ed kvality, kter\u00fd umo\u017e\u0148uje bezpe\u010dn\u00e9 a efektivn\u00ed procesy. Tyto procesy jsou navr\u017eeny tak, aby zajistily konzistentn\u00ed n\u00e1vrh, v\u00fdvoj, v\u00fdrobu, instalaci, dod\u00e1vku, monitorov\u00e1n\u00ed, sledov\u00e1n\u00ed a likvidaci zdravotnick\u00fdch prost\u0159edk\u016f, kter\u00e9 pokr\u00fdvaj\u00ed cel\u00fd \u017eivotn\u00ed cyklus v\u00fdrobku. To m\u00e1 zajistit, aby zdravotnick\u00e9 prost\u0159edky a diagnostika in vitro mohly b\u00fdt bezpe\u010dn\u011b pou\u017e\u00edv\u00e1ny k ur\u010den\u00e9mu \u00fa\u010delu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jak\u00fd je pr\u00e1vn\u00ed v\u00fdznam normy ISO 13485?<\/h2>\n\n\n\n<p>Regula\u010dn\u00ed programy schvalov\u00e1n\u00ed zdravotnick\u00fdch prost\u0159edk\u016f nebo diagnostik in vitro se \u010dasto op\u00edraj\u00ed o po\u017eadavky normy ISO 13485. Obecn\u00e9 po\u017eadavky normy ISO 13485 jsou roz\u0161\u00ed\u0159eny a p\u0159izp\u016fsobeny specifick\u00fdm pr\u00e1vn\u00edm po\u017eadavk\u016fm trhu prost\u0159ednictv\u00edm konkretizac\u00ed a dopl\u0148k\u016f.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jak\u00fd je rozd\u00edl mezi normami ISO 13485 a EN ISO 13485?<\/h2>\n\n\n\n<p>Norma ISO 13485 je mezin\u00e1rodn\u011b uzn\u00e1vanou z\u00e1kladn\u00ed verz\u00ed normy, kter\u00e1 v\u0161ak byla evropskou normaliza\u010dn\u00ed organizac\u00ed harmonizov\u00e1na do podoby evropsk\u00e9 normy, aby mohla b\u00fdt zohledn\u011bna v evropsk\u00fdch regula\u010dn\u00edch schvalovac\u00edch postupech. Dodr\u017eov\u00e1n\u00edm harmonizovan\u00e9 normy m\u016f\u017ee v\u00fdrobce prok\u00e1zat, \u017ee jeho v\u00fdrobky nebo slu\u017eby spl\u0148uj\u00ed technick\u00e9 po\u017eadavky p\u0159\u00edslu\u0161n\u00fdch pr\u00e1vn\u00edch p\u0159edpis\u016f EU, a v p\u0159\u00edpad\u011b pot\u0159eby tak\u00e9 uplatnit tzv. p\u0159edpoklad shody.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Mezin\u00e1rodn\u00ed norma ISO 13485 slou\u017e\u00ed jako z\u00e1klad pro certifikaci syst\u00e9m\u016f \u0159\u00edzen\u00ed kvality ve spole\u010dnostech, kter\u00e9 vyr\u00e1b\u011bj\u00ed nebo distribuuj\u00ed zdravotnick\u00e9 prost\u0159edky nebo se pod\u00edlej\u00ed na jejich v\u00fdrob\u011b v r\u00e1mci dodavatelsk\u00e9ho \u0159et\u011bzce. Syst\u00e9m \u0159\u00edzen\u00ed kvality tvo\u0159\u00ed p\u00e1te\u0159 \u010dinnost\u00ed a \u00fakol\u016f v\u00fdrobc\u016f zdravotnick\u00fdch prost\u0159edk\u016f. Zaji\u0161\u0165uje spolehliv\u00e9 dodr\u017eov\u00e1n\u00ed intern\u00edch i extern\u00edch p\u0159edpis\u016f. Vhodnou certifikac\u00ed sv\u00e9ho syst\u00e9mu mohou v\u00fdrobci vybudovat<\/p>\n","protected":false},"author":3,"featured_media":8480,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19403,19463],"tags":[],"class_list":["post-8495","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-cs","category-standard-cs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - Syst\u00e9m managementu kvality pro zdravotnick\u00e9 prost\u0159edky - 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\/cs\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Syst\u00e9m managementu kvality pro zdravotnick\u00e9 prost\u0159edky - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"Mezin\u00e1rodn\u00ed norma ISO 13485 slou\u017e\u00ed jako z\u00e1klad pro certifikaci syst\u00e9m\u016f \u0159\u00edzen\u00ed kvality ve spole\u010dnostech, kter\u00e9 vyr\u00e1b\u011bj\u00ed nebo distribuuj\u00ed zdravotnick\u00e9 prost\u0159edky nebo se pod\u00edlej\u00ed na jejich v\u00fdrob\u011b v r\u00e1mci dodavatelsk\u00e9ho \u0159et\u011bzce. Syst\u00e9m \u0159\u00edzen\u00ed kvality tvo\u0159\u00ed p\u00e1te\u0159 \u010dinnost\u00ed a \u00fakol\u016f v\u00fdrobc\u016f zdravotnick\u00fdch prost\u0159edk\u016f. Zaji\u0161\u0165uje spolehliv\u00e9 dodr\u017eov\u00e1n\u00ed intern\u00edch i extern\u00edch p\u0159edpis\u016f. 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