{"id":1749,"date":"2021-02-11T10:28:43","date_gmt":"2021-02-11T10:28:43","guid":{"rendered":"http:\/\/medicallab.coreco.es\/?p=1533"},"modified":"2026-07-01T15:54:39","modified_gmt":"2026-07-01T15:54:39","slug":"fabrication-de-refrigerateurs-medicaux-conformement-a-la-norme-iso-13485","status":"publish","type":"post","link":"https:\/\/medicallab.coreco.es\/fr\/fabricacion-de-refrigeradores-medicos-segun-la-norma-iso-13485\/","title":{"rendered":"Fabrication de r\u00e9frig\u00e9rateurs m\u00e9dicaux conform\u00e9ment \u00e0 la norme ISO 13485"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Dans cet article, nous allons approfondir les aspects les plus importants de la fabrication de r\u00e9frig\u00e9rateurs m\u00e9dicaux conform\u00e9ment \u00e0 la norme ISO 13485, ainsi que les exigences en mati\u00e8re de processus qualit\u00e9 que cela implique pour le fabricant.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Importance de la norme ISO 13485<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Dans le cas des r\u00e9frig\u00e9rateurs \u00e0 usage m\u00e9dical, peut-\u00eatre plus que pour tout autre produit, la qualit\u00e9 a une incidence directe sur l'efficacit\u00e9 de l'appareil et sur la s\u00e9curit\u00e9 des patients, des utilisateurs et, \u00e9ventuellement, d'autres personnes. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">C'est pourquoi de nombreuses r\u00e9glementations nationales exigent que les fabricants et les fournisseurs de r\u00e9frig\u00e9rateurs m\u00e9dicaux d\u00e9montrent qu'ils disposent d'un syst\u00e8me de gestion de la qualit\u00e9 ayant fait l'objet d'un audit et d'une certification par un organisme ind\u00e9pendant.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les dispositifs m\u00e9dicaux fabriqu\u00e9s ou commercialis\u00e9s par des entreprises ne disposant pas d'un syst\u00e8me de gestion de la qualit\u00e9 certifi\u00e9 ont g\u00e9n\u00e9ralement plus de mal \u00e0 \u00eatre homologu\u00e9s sur les principaux march\u00e9s. <\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Expiration de la norme<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Les entreprises d\u00e9j\u00e0 titulaires d'un certificat conforme \u00e0 la norme EN ISO 13485 devaient faire passer leur certification \u00e0 la nouvelle norme avant le 31 mai 2019. Tous les certificats d\u00e9livr\u00e9s selon l'ancienne norme resteront d\u00e9sormais valables pendant une p\u00e9riode de trois ans, jusqu'\u00e0 ce que la Commission europ\u00e9enne publie la date d'expiration de la norme remplac\u00e9e. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apr\u00e8s cette publication, la date d'expiration deviendra la date de validit\u00e9. Les fabricants titulaires de certificats dont la dur\u00e9e de validit\u00e9 est encore longue doivent s'y pr\u00e9parer \u00e0 l'avance et veiller \u00e0 ce que leur certificat soit mis en conformit\u00e9 avec la nouvelle norme EN ISO 13485:2016 avant la date d'expiration de l'ancienne norme.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Qu'est-ce que la norme ISO 13485 ?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La norme EN ISO 13485 \u00ab Dispositifs m\u00e9dicaux : Syst\u00e8mes de gestion de la qualit\u00e9 \u2013 Exigences \u00e0 des fins r\u00e9glementaires \u00bb traite des<a href=\"https:\/\/www.aenor.com\/certificacion\/quimico-farmaceutico-y-cosmetico\/productos-sanitarios\" data-type=\"URL\" data-id=\"https:\/\/www.aenor.com\/certificacion\/quimico-farmaceutico-y-cosmetico\/productos-sanitarios\"> exigences auxquelles doivent se conformer les fabricants et les fournisseurs de dispositifs m\u00e9dicaux <\/a>dans le d\u00e9veloppement, la mise en \u0153uvre et la maintenance de syst\u00e8mes de gestion destin\u00e9s au secteur des dispositifs m\u00e9dicaux. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00c9labor\u00e9e \u00e0 l'origine dans les ann\u00e9es 90, cette norme d\u00e9finit les exigences relatives aux syst\u00e8mes de gestion de la qualit\u00e9 qui r\u00e9pondent aux attentes des clients, ainsi qu'aux exigences r\u00e9glementaires de l'Union europ\u00e9enne (UE), du Canada et d'autres march\u00e9s importants \u00e0 travers le monde.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La norme EN ISO 13485 a un champ d'application et un objectif similaires \u00e0 ceux de la norme ISO 9001, mais elle contient des exigences suppl\u00e9mentaires sp\u00e9cifiques aux dispositifs m\u00e9dicaux, parmi lesquels figurent les r\u00e9frig\u00e9rateurs m\u00e9dicaux, et elle reformule certaines des exigences de la norme ISO 9001. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Par cons\u00e9quent, sur la plupart des march\u00e9s, la certification selon la norme ISO 9001 ne constitue pas un substitut ad\u00e9quat \u00e0 la certification selon les exigences de la norme EN ISO 13485.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Harmonisations de la norme ISO 13485 (EN ISO 13485)<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>les proc\u00e9dures d'\u00e9valuation de la conformit\u00e9 pr\u00e9vues par la directive relative aux dispositifs m\u00e9dicaux (93\/42\/CEE),<\/li><li>la directive relative aux dispositifs m\u00e9dicaux de diagnostic in vitro (98\/79\/CE)&nbsp;<\/li><li>la directive relative aux dispositifs m\u00e9dicaux implantables actifs<\/li><li>appareils (90\/385\/CEE).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pourquoi l'audit selon la norme EN ISO 13485 est-il important ?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Au sein de l'UE, les exigences de la norme EN ISO 13485 ont \u00e9t\u00e9 harmonis\u00e9es avec celles de la directive europ\u00e9enne relative aux dispositifs m\u00e9dicaux (93\/42\/CEE), la directive relative aux dispositifs m\u00e9dicaux de diagnostic in vitro (98\/79\/CE) et la directive relative aux dispositifs m\u00e9dicaux implantables actifs (90\/385\/CEE). <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La certification selon la norme EN ISO 13485 par un organisme de certification accr\u00e9dit\u00e9 donne lieu \u00e0 une pr\u00e9somption de conformit\u00e9. Cela signifie qu'un fabricant certifi\u00e9 selon la norme EN ISO 13485 est pr\u00e9sum\u00e9 respecter les aspects des exigences de ces directives couverts par la norme.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Homologation aux \u00c9tats-Unis et au Canada<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Aux \u00c9tats-Unis, les rapports d\u2019audit conformes \u00e0 la norme EN ISO 13485 sont actuellement accept\u00e9s par l\u2019autorit\u00e9 charg\u00e9e de l\u2019homologation des dispositifs m\u00e9dicaux, la Food and Drug Administration (FDA), comme preuve qu\u2019un fabricant respecte les exigences de la FDA en mati\u00e8re de syst\u00e8mes de gestion de la qualit\u00e9 (Quality System Regulations, QSR). <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sant\u00e9 Canada exige \u00e9galement que les fabricants de dispositifs m\u00e9dicaux souhaitant commercialiser leurs produits au Canada disposent de syst\u00e8mes de gestion de la qualit\u00e9 certifi\u00e9s conformes \u00e0 la norme EN ISO 13485. \u00c0 l\u2019avenir, les audits de gestion de la qualit\u00e9 pour le Canada seront exig\u00e9s dans le cadre des audits du MDSAP.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00c9laboration de la r\u00e9glementation<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Cette norme a \u00e9t\u00e9 \u00e9labor\u00e9e par le Comit\u00e9 technique ISO\/TC 210 \u00ab Gestion de la qualit\u00e9 et aspects g\u00e9n\u00e9raux connexes relatifs aux dispositifs m\u00e9dicaux \u00bb (secr\u00e9tariat : ANSI, \u00c9tats-Unis) en collaboration avec le Comit\u00e9 technique CEN\/CLC\/TC 3 \u00ab Gestion de la qualit\u00e9 et aspects g\u00e9n\u00e9raux correspondants pour les dispositifs m\u00e9dicaux \u00bb (secr\u00e9tariat : NEN, Pays-Bas), avec la participation d'experts de tous les pays europ\u00e9ens. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tous les organismes nationaux comp\u00e9tents participent \u00e9galement aux groupes de travail consacr\u00e9s \u00e0 la \u00ab gestion de la qualit\u00e9 et aux aspects g\u00e9n\u00e9raux li\u00e9s aux dispositifs m\u00e9dicaux \u00bb.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Caract\u00e9ristiques techniques<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">La norme DIN EN ISO 13485:2016-08 sp\u00e9cifie les exigences relatives \u00e0 un syst\u00e8me de gestion de la qualit\u00e9 lorsqu'une entreprise doit d\u00e9montrer sa capacit\u00e9 \u00e0 fournir des dispositifs m\u00e9dicaux et des services associ\u00e9s qui r\u00e9pondent en permanence aux exigences des clients et aux exigences r\u00e9glementaires applicables. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ces entreprises peuvent intervenir \u00e0 une ou plusieurs \u00e9tapes du cycle de vie d'un dispositif m\u00e9dical, notamment le d\u00e9veloppement, la production, le stockage et la distribution, l'installation ou la maintenance d'un dispositif m\u00e9dical, ainsi que la mise en place ou la r\u00e9alisation d'activit\u00e9s connexes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dans le cas de Coreco, S.A., nous avons <a href=\"https:\/\/medicallab.coreco.es\/fr\/certificados-de-calidad\/\" data-type=\"URL\" data-id=\"https:\/\/medicallab.coreco.es\/certificados-de-calidad\/\">apr\u00e8s avoir satisfait \u00e0 toutes les exigences de la norme<\/a> et nous fournissons des \u00e9quipements de r\u00e9frig\u00e9ration r\u00e9pondant \u00e0 des normes de qualit\u00e9 tr\u00e8s \u00e9lev\u00e9es.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Cette norme peut-elle s'appliquer aux fournisseurs ?<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Cette norme peut \u00e9galement \u00eatre appliqu\u00e9e par les fournisseurs ou les parties externes qui fournissent des produits, y compris les services li\u00e9s au syst\u00e8me de gestion de la qualit\u00e9, \u00e0 ces organisations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Par rapport \u00e0 la norme DIN EN ISO 13485:2012-11, une r\u00e9vision technique en profondeur a \u00e9t\u00e9 effectu\u00e9e. Parmi les modifications, on peut notamment citer :<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Conformit\u00e9 \u00e0 la norme ISO 9001:2008,<\/li><li>R\u00e9vision des d\u00e9finitions,<\/li><li>V\u00e9rification des exigences en mati\u00e8re de documentation,<\/li><li>Int\u00e9gration d'une approche fond\u00e9e sur les risques,<\/li><li>ajout d'exigences relatives \u00e0 la validation de l'utilisation des logiciels,<\/li><li>Examen des exigences relatives \u00e0 l'infrastructure ainsi qu'\u00e0 l'environnement de travail ;,<\/li><li>Ajout d'exigences relatives \u00e0 la fabrication des produits,<\/li><li>R\u00e9vision des exigences en mati\u00e8re de mesure, d'analyse et d'am\u00e9lioration.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">La relation entre les normes ISO 13485:2016 et ISO 9001:2015 est pr\u00e9sent\u00e9e dans une annexe informative.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cette norme est conforme aux exigences essentielles des directives europ\u00e9ennes 90\/385\/CEE relative aux dispositifs implantables actifs, 93\/42\/CEE relative aux dispositifs m\u00e9dicaux et 98\/79\/CE relative aux dispositifs m\u00e9dicaux de diagnostic in vitro.<\/p>","protected":false},"excerpt":{"rendered":"<p>Fabrication de r\u00e9frig\u00e9rateurs m\u00e9dicaux conform\u00e9ment \u00e0 la norme ISO 13485<\/p>","protected":false},"author":1,"featured_media":1777,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[9],"tags":[],"class_list":["post-1749","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categoria"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.6 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Fabricaci\u00f3n de refrigeradores m\u00e9dicos seg\u00fan la norma ISO 13485 | Medical Lab<\/title>\n<meta name=\"description\" content=\"Sin duda, la fabricaci\u00f3n de refrigeradores m\u00e9dicos seg\u00fan la norma ISO 13485 exige unos altos \u00edndices de calidad en todos los procesos. 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