{"id":4377,"date":"2025-10-03T11:28:48","date_gmt":"2025-10-03T16:28:48","guid":{"rendered":"https:\/\/www.accademia.com\/?page_id=4377"},"modified":"2026-02-23T16:49:46","modified_gmt":"2026-02-23T21:49:46","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/www.accademia.com\/fr\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4377\" class=\"elementor elementor-4377\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49c1c3e e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"49c1c3e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01e6a3b elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-spacer\" data-id=\"01e6a3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ccb69a elementor-hidden-desktop elementor-widget elementor-widget-spacer\" data-id=\"8ccb69a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7db521e elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7db521e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">La gestion de la qualit\u00e9 pour <br>les appareils m\u00e9dicaux <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7af5a1a elementor-hidden-desktop elementor-widget elementor-widget-spacer\" data-id=\"7af5a1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-096573d elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-spacer\" data-id=\"096573d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-aff50d2 e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"aff50d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eb8a5e6 elementor-widget elementor-widget-button\" data-id=\"eb8a5e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.accademia.com\/services\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">&lt; Retour \u00e0 la page pr\u00e9c\u00e9dente<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff23714 elementor-widget elementor-widget-spacer\" data-id=\"ff23714\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e970670 elementor-widget elementor-widget-heading\" data-id=\"e970670\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Un cadre pour l\u2019excellence m\u00e9dicale : ISO 13485<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b29ce34 elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"b29ce34\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b907e4 elementor-widget elementor-widget-text-editor\" data-id=\"8b907e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\">La s\u00e9curit\u00e9 des \u00e9quipements m\u00e9dicaux est une priorit\u00e9 fondamentale pour les Canadiens, car elle garantit la protection des patients et des utilisateurs tout en renfor\u00e7ant la confiance dans le syst\u00e8me de sant\u00e9. C\u2019est pourquoi la norme ISO 13485 joue un r\u00f4le si important. Cette norme internationale \u00e9tablit des exigences strictes pour les syst\u00e8mes de gestion de la qualit\u00e9 des dispositifs m\u00e9dicaux, afin d\u2019assurer leur conception, leur fabrication et leur utilisation en toute s\u00e9curit\u00e9. Elle constitue un cadre essentiel pour les entreprises souhaitant r\u00e9pondre aux attentes \u00e9lev\u00e9es en mati\u00e8re de qualit\u00e9 et de conformit\u00e9 r\u00e9glementaire, tout en contribuant \u00e0 l\u2019am\u00e9lioration continue des pratiques dans le domaine de la sant\u00e9.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9eca428 e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"9eca428\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-92c0adf elementor-widget elementor-widget-spacer\" data-id=\"92c0adf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f65849f elementor-widget elementor-widget-heading\" data-id=\"f65849f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Nos diff\u00e9rentes formations offertes sur le sujet<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b2f14d elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"0b2f14d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20a9788 elementor-widget elementor-widget-n-accordion\" data-id=\"20a9788\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-3420\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-3420\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Comprendre 13485 : 2016 \u2013 7 heures  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-3420\" class=\"elementor-element elementor-element-63f872a e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"63f872a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9e7153d elementor-widget elementor-widget-text-editor\" data-id=\"9e7153d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6><strong>Objectif<\/strong><\/h6><p>Ce cours vise \u00e0 ce que les participants d\u00e9veloppent une bonne compr\u00e9hension de chacun des articles de la norme ISO 13485 : 2016, comment ils sont interreli\u00e9s pour cr\u00e9er un syst\u00e8me de gestion de la qualit\u00e9 dynamique qui contribue \u00e0 l\u2019atteinte des objectifs qualit\u00e9 de l\u2019organisme en coh\u00e9rence avec ses objectifs strat\u00e9giques.<\/p><h6><strong>Client\u00e8le vis\u00e9e<\/strong><\/h6><p style=\"font-weight: 400;\">Ce cours vise surtout le personnel d\u2019encadrement et, de fa\u00e7on plus g\u00e9n\u00e9rale, tout le personnel qui veut d\u00e9couvrir et comprendre la norme ou le personnel qui, bien que d\u00e9j\u00e0 quelque peu familier avec la norme, veut cependant rafra\u00eechir sa compr\u00e9hension des exigences.<\/p><h6><strong>\u00c9l\u00e9ments de contenu<\/strong><\/h6><p style=\"font-weight: 400;\">Le cours aborde les sujets suivants :<\/p><ul><li>Concepts et d\u00e9finitions<\/li><li>Engagement de la direction<\/li><li>Gestion des ressources<\/li><li>R\u00e9alisation du produit<\/li><li><span style=\"font-weight: 400;\">Mesure, analyse et am\u00e9lioration<\/span><\/li><\/ul><h6><strong>Notes<\/strong><\/h6><p>Il n\u2019y a pas de pr\u00e9requis pour participer \u00e0 ce cours. Une certaine connaissance des dispositifs m\u00e9dicaux permettra cependant de maximiser les b\u00e9n\u00e9fices de la formation.<\/p><p>\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3abfa7 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"c3abfa7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"http:\/\/www.accademia.com\/wp-content\/uploads\/2026\/02\/COM-13485-PLAN.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Plan de cours t\u00e9l\u00e9chargeable<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43b6577 elementor-widget elementor-widget-spacer\" data-id=\"43b6577\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dd17e5c e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"dd17e5c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-313c43c e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"313c43c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div class=\"elementor-element elementor-element-163c5a5 e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"163c5a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-320a8c2 e-con-full e-ecs-flex e-flex elementor-invisible e-con e-child\" data-id=\"320a8c2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;slideInRight&quot;,&quot;animation_mobile&quot;:&quot;none&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-317e6c8 elementor-widget elementor-widget-heading\" data-id=\"317e6c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Et si ce n'\u00e9tait pas exactement de la formation dont vous aviez besoin?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50417e4 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"50417e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a03e2d8 elementor-widget elementor-widget-text-editor\" data-id=\"a03e2d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Au-del\u00e0 du d\u00e9veloppement des connaissances, nous proposons \u00e9galement un accompagnement personnalis\u00e9 : un soutien pour obtenir votre certification, le maintien de votre syst\u00e8me de gestion avec une ressource exp\u00e9riment\u00e9e \u00e0 temps partiel, ou encore un appui strat\u00e9gique pour am\u00e9liorer vos processus.<\/p><p>Quelle que soit votre situation, nous sommes l\u00e0 pour vous aider \u00e0 avancer efficacement.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-56d9496 e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"56d9496\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div class=\"elementor-element elementor-element-5244a1b e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"5244a1b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-30f3c82 elementor-mobile-align-center elementor-align-center elementor-widget elementor-widget-button\" data-id=\"30f3c82\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div 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