{"id":58162,"date":"2023-11-02T09:09:52","date_gmt":"2023-11-02T09:09:52","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/dispositifs-medicaux-auditeur-interne-iso-13485\/"},"modified":"2023-11-02T09:09:52","modified_gmt":"2023-11-02T08:09:52","slug":"dispositifs-medicaux-auditeur-interne-iso-13485","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/dispositifs-medicaux-auditeur-interne-iso-13485\/","title":{"rendered":"Dispositifs m\u00e9dicaux : Auditeur interne ISO 13485"},"content":{"rendered":"<p><a href=\"https:\/\/www.iso.org\/standard\/59752.html\">L\u2019ISO 13485<\/a> d\u00e9finit les exigences de management de la qualit\u00e9 que les organismes de dispositifs m\u00e9dicaux doivent respecter pour satisfaire aux r\u00e9gulateurs et prot\u00e9ger les patients. Les audits internes permettent de v\u00e9rifier le respect de ces exigences. Ce cours offre une introduction pratique \u00e0 la planification, la r\u00e9alisation et le rapport d\u2019audits internes selon les lignes directrices ISO 13485:2016 et ISO 19011:2018.  <\/p>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Principes et exigences de l\u2019ISO 13485:2016<\/li>\n<li>Planifier, r\u00e9aliser et rapporter des audits internes<\/li>\n<li>Appliquer les lignes directrices d\u2019audit ISO 19011 dans le secteur des dispositifs m\u00e9dicaux<\/li>\n<li>Identifier les non-conformit\u00e9s et soutenir les actions correctives et pr\u00e9ventives<\/li>\n<\/ul>\n<p><strong>\u00c0 qui s\u2019adresse ce cours ?<\/strong><\/p>\n<ul>\n<li>Responsables <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/management-de-la-qualite-pour-les-dispositifs-medicaux-iso-134852016\/\">Assurance Qualit\u00e9<\/a><\/li>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\">Sp\u00e9cialistes des Affaires R\u00e9glementaires<\/a><\/li>\n<li>Ing\u00e9nieurs Syst\u00e8mes Qualit\u00e9<\/li>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/audit-bpf-interne-role-de-lauditeur-bpf\/\">Auditeurs internes<\/a><\/li>\n<\/ul>\n<p>Apr\u00e8s avoir r\u00e9ussi, vous recevrez un <strong>certificat valid\u00e9 et accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 \u00e0 la documentation d\u2019audit et de conformit\u00e9.<\/p>\n<h3>Programme :<\/h3>\n<p><strong>Introduction<\/strong><br \/>\n<strong>Aper\u00e7u de la norme interne ISO 13485 : 2016<\/strong><br \/>\n<strong>Le\u00e7on 1 : Syst\u00e8me de management de la qualit\u00e9&lt;\/strong<br \/>\n<strong>Le\u00e7on 2 : Responsabilit\u00e9 de la direction<\/strong><br \/>\n<strong>Le\u00e7on 3 : Management des ressources<\/strong><br \/>\n<strong>Le\u00e7on 4 : R\u00e9alisation du produit<\/strong><br \/>\n<strong>Le\u00e7on 5 : Mesure, analyse et am\u00e9lioration<\/strong><br \/>\n<strong>Glossaire<\/strong><br \/>\n<strong>\u00c9valuation<\/strong><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019ISO 13485 d\u00e9finit les exigences de management de la qualit\u00e9 que les organismes de dispositifs m\u00e9dicaux doivent respecter pour satisfaire aux r\u00e9gulateurs et prot\u00e9ger les patients. Les audits internes permettent de v\u00e9rifier le respect de ces exigences. Ce cours offre une introduction pratique \u00e0 la planification, la r\u00e9alisation et le rapport d\u2019audits internes selon les [&hellip;]<\/p>\n","protected":false},"featured_media":44699,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,257,256],"product_tag":[],"class_list":{"0":"post-58162","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-assurance-qualite","8":"product_cat-dispositifs-medicaux","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dispositifs m\u00e9dicaux : Cours et certification d\u2019auditeur interne ISO 13485<\/title>\n<meta name=\"description\" content=\"Apprenez les exigences d\u2019audit interne ISO 13485 avec notre cours certifi\u00e9 en ligne. 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