{"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:\/\/icr.you2.pl\/fr\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>Qu'est-ce que la norme ISO 13485 ?<\/h4>\n<p>La norme internationale ISO 13485 \"Dispositifs m\u00e9dicaux - Syst\u00e8mes de management de la qualit\u00e9 - Exigences \u00e0 des fins r\u00e9glementaires\" traite des syst\u00e8mes de management de la qualit\u00e9 pour la fabrication de dispositifs m\u00e9dicaux. Elle d\u00e9finit les exigences d'un syst\u00e8me de gestion de la qualit\u00e9 qui doivent \u00eatre respect\u00e9es par un organisme tout au long du cycle de production. Les exigences de la norme ISO 13485 s'appliquent aux organisations, quelle que soit leur taille ou leur type.<\/p>\n<h4>Champ d'application de la norme :<\/h4>\n<p>La norme ISO 13485 comprend des exigences en mati\u00e8re de SMQ lorsqu'un organisme doit d\u00e9montrer sa capacit\u00e9 \u00e0 fournir des dispositifs m\u00e9dicaux et des services connexes, en satisfaisant en permanence aux exigences des clients et aux exigences r\u00e9glementaires applicables. Ces organismes peuvent \u00eatre impliqu\u00e9s dans une ou plusieurs \u00e9tapes du cycle de vie du produit, y compris la conception et le d\u00e9veloppement, la fabrication, le stockage et la distribution, l'installation ou l'entretien d'un dispositif m\u00e9dical, ainsi que la conception et le d\u00e9veloppement ou la fourniture de services connexes (par exemple, l'assistance technique).<\/p>\n<p>Cette norme peut \u00e9galement \u00eatre utilis\u00e9e par les fournisseurs ou les parties externes qui fournissent un produit \u00e0 un tel organisme, y compris les services li\u00e9s au SMQ.<\/p>\n<h4>Exigences g\u00e9n\u00e9rales :<\/h4>\n<p>Chaque organisation devrait :<\/p>\n<ul>\n<li>Documenter le syst\u00e8me de gestion de la qualit\u00e9 et maintenir son efficacit\u00e9 ;<\/li>\n<li>\u00c9tablir, mettre en \u0153uvre et maintenir toutes les exigences, proc\u00e9dures et actions contenues dans la norme ;<\/li>\n<li>Identifier les processus n\u00e9cessaires au SMQ et leur application dans l'organisation ;<\/li>\n<li>Utiliser une approche bas\u00e9e sur le risque pour superviser les processus pertinents ;<\/li>\n<li>Identifier la s\u00e9quence de ces processus et leurs interactions ;<\/li>\n<li>G\u00e9rer ces processus de mani\u00e8re appropri\u00e9e<\/li>\n<li>Documenter les proc\u00e9dures de validation de l'utilisation des logiciels informatiques utilis\u00e9s dans le SMQ ;<\/li>\n<\/ul>\n<h4>Avantages de la norme ISO 13485 :<\/h4>\n<ul>\n<li>Accro\u00eetre la cr\u00e9dibilit\u00e9 de l'entreprise ;<\/li>\n<li>Capacit\u00e9 \u00e0 acc\u00e9der aux march\u00e9s nationaux et \u00e9trangers ;<\/li>\n<li>Accro\u00eetre la comp\u00e9titivit\u00e9 de l'organisation ;<\/li>\n<li>Les processus de l'organisation deviennent plus transparents ;<\/li>\n<li>Minimiser le risque d'un produit d\u00e9fectueux ;<\/li>\n<li>R\u00e9duire le nombre de plaintes.<\/li>\n<\/ul>\n<h4>Qui doit \u00eatre certifi\u00e9 ISO 13485 ?<\/h4>\n<p>Le syst\u00e8me de gestion de la qualit\u00e9 conforme \u00e0 la norme ISO 13485 est mis en \u0153uvre par les fabricants de dispositifs m\u00e9dicaux et d'autres entreprises impliqu\u00e9es dans le secteur des dispositifs m\u00e9dicaux (par exemple, les entreprises de services d'\u00e9quipement m\u00e9dical).<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Qu'est-ce que la norme ISO 13485 ? La norme internationale ISO 13485 \"Dispositifs m\u00e9dicaux - Syst\u00e8mes de management de la qualit\u00e9 - Exigences \u00e0 des fins r\u00e9glementaires\" traite des syst\u00e8mes de management de la qualit\u00e9 pour la fabrication de dispositifs m\u00e9dicaux. Elle d\u00e9finit les exigences d'un syst\u00e8me de gestion de la qualit\u00e9 qui doivent \u00eatre respect\u00e9es par une organisation tout au long du cycle de production. Les exigences de la norme ISO 13485 s'appliquent aux organisations, quel que soit leur...&nbsp;<a href=\"https:\/\/icr.you2.pl\/fr\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">Lire la suite \"<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 v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - ICR POLSKA - badania i certyfikacja<\/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:\/\/icr.you2.pl\/fr\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - ICR POLSKA - badania i certyfikacja\" \/>\n<meta property=\"og:description\" content=\"&nbsp; Czym jest ISO 13485? Mi\u0119dzynarodowa norma ISO 13485 \u201eWyroby medyczne &#8212; Systemy zarz\u0105dzania jako\u015bci\u0105 &#8212; Wymagania do cel\u00f3w przepis\u00f3w prawnych&#8221; dotyczy system\u00f3w zarz\u0105dzania jako\u015bci\u0105 w produkcji wyrob\u00f3w medycznych. Okre\u015bla ona wymagania dla systemu zarz\u0105dzania jako\u015bci\u0105, kt\u00f3re powinny by\u0107 spe\u0142nione przez organizacj\u0119 w ca\u0142ym cyklu produkcji. 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