{"id":58006,"date":"2026-09-23T09:42:27","date_gmt":"2026-09-23T07:42:27","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/iso-90012015-systeme-de-management-de-la-qualite-pour-lindustrie-pharmaceutique\/"},"modified":"2026-10-01T11:58:52","modified_gmt":"2026-10-01T09:58:52","slug":"iso-90012015-systeme-de-management-de-la-qualite-pour-lindustrie-pharmaceutique","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/iso-90012015-systeme-de-management-de-la-qualite-pour-lindustrie-pharmaceutique\/","title":{"rendered":"ISO 9001:2026&nbsp;: Syst\u00e8mes de management de la qualit\u00e9"},"content":{"rendered":"<p>L\u2019ISO 9001:2026 est la premi\u00e8re r\u00e9vision compl\u00e8te en onze ans, et <strong>tous les certificats doivent basculer d\u2019ici septembre 2029.<\/strong> Cinq clauses ont chang\u00e9 sur le fond : culture qualit\u00e9 et \u00e9thique, changement climatique, politique li\u00e9e \u00e0 la strat\u00e9gie, risques dissoci\u00e9s des opportunit\u00e9s, sensibilisation \u00e9largie. Cette formation en ligne de deux heures certifie vos \u00e9quipes sur l\u2019\u00e9dition 2026. <\/p>\n<p>En dix le\u00e7ons pratiques, ce cours certifi\u00e9 couvre l\u2019ensemble de la norme clause par clause, avec huit cas r\u00e9els et, dans chaque le\u00e7on, un briefing \u00ab&nbsp;ce que recherchent les auditeurs&nbsp;\u00bb, de l\u2019approche processus et de la pens\u00e9e fond\u00e9e sur les risques jusqu\u2019\u00e0 un plan de transition compatible avec les BPF, <a href=\"https:\/\/gxp-training.com\/online-course\/quality-management-for-medical-devices-iso-134852016\/\">ISO 13485<\/a> et ICH Q10. Son certificat tra\u00e7able vous apporte une preuve pr\u00eate pour l\u2019audit que vous, ou votre \u00e9quipe, \u00eates pr\u00eats \u00e0 appliquer l\u2019ISO 9001:2026 dans des activit\u00e9s r\u00e9glement\u00e9es. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>Pourquoi les \u00e9quipes choisissent ce cours<\/strong><\/p>\n<ul>\n<li>Con\u00e7u par des experts des syst\u00e8mes de management de la qualit\u00e9 issus des sciences de la vie<\/li>\n<li>Chaque le\u00e7on se termine par ce que recherchent les auditeurs lors du premier audit 2026<\/li>\n<li>Cas r\u00e9els&nbsp;: Kobe Steel, Takata, Ranbaxy, la contamination \u00e0 l\u2019h\u00e9parine de 2008, Philips Respironics, l\u2019ouragan Maria<\/li>\n<li>R\u00e9dig\u00e9 pour les pharmaceutiques, les dispositifs m\u00e9dicaux, les laboratoires et leurs fournisseurs<\/li>\n<li>Acc\u00e8s d&rsquo;un an par apprenant et un certificat CPD\/CEU que votre AQ peut v\u00e9rifier en ligne<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Ce que vous allez apprendre<\/strong><\/p>\n<ul>\n<li>Identifier les cinq changements de fond et les clarifications qui ressemblent seulement \u00e0 des changements<\/li>\n<li>Piloter vos processus avec le PDCA et une pens\u00e9e fond\u00e9e sur les risques tra\u00e7able par un auditeur<\/li>\n<li>Traiter le changement climatique et les parties int\u00e9ress\u00e9es comme de v\u00e9ritables facteurs de contexte<\/li>\n<li>Fournir \u00e0 la direction des preuves de culture qualit\u00e9, d\u2019int\u00e9grit\u00e9 et de comportement \u00e9thique<\/li>\n<li>S\u00e9parer les actions li\u00e9es aux risques des actions li\u00e9es aux opportunit\u00e9s, et v\u00e9rifier les changements planifi\u00e9s<\/li>\n<li>Ma\u00eetriser la conception, les fournisseurs, la lib\u00e9ration et les produits non conformes en conditions <a href=\"https:\/\/gxp-training.com\/online-course\/gxp1861-introduction-to-good-manufacturing-practice\/\">BPF<\/a><\/li>\n<li>R\u00e9aliser une analyse des \u00e9carts et un plan de transition qui passent le premier <a href=\"https:\/\/gxp-training.com\/online-course\/gxp1248-regulatory-compliance-inspections-and-external-audits\/\">audit<\/a> selon 2026<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s\u2019adresse cette formation<\/strong><\/p>\n<ul>\n<li>\u00c9quipes d\u2019assurance qualit\u00e9 et de contr\u00f4le qualit\u00e9<\/li>\n<li>Sp\u00e9cialistes des affaires r\u00e9glementaires et de la conformit\u00e9<\/li>\n<li>Auditeurs internes et repr\u00e9sentants de la direction<\/li>\n<li>Managers et responsables de processus en pharma, dispositifs m\u00e9dicaux, laboratoires et chez leurs fournisseurs<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u00c0 l\u2019issue de la formation, chaque apprenant re\u00e7oit un<strong> certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 aux audits et \u00e0 la documentation de conformit\u00e9.<\/p>\n<h3><\/h3>\n<h3>Programme<\/h3>\n<p><strong>Le\u00e7on&nbsp;: Br\u00e8ve histoire de l\u2019ISO 9001<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;1&nbsp;: Ce qui a chang\u00e9 dans l\u2019ISO 9001:2026, et ce qui n\u2019a pas chang\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;2&nbsp;: Le moteur de la norme&nbsp;: processus, PDCA et pens\u00e9e fond\u00e9e sur les risques<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;3&nbsp;: Conna\u00eetre votre organisation&nbsp;: contexte, climat et parties int\u00e9ress\u00e9es<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;4&nbsp;: Leadership, culture qualit\u00e9 et comportement \u00e9thique<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;5&nbsp;: Planifier les risques, les opportunit\u00e9s et le changement<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;6&nbsp;: Personnes, connaissances et informations document\u00e9es<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;7&nbsp;: Des exigences clients \u00e0 la conception et aux fournisseurs<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;8&nbsp;: Fournir des produits et services conformes<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;9&nbsp;: Mesurer, auditer et revoir la performance<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;10&nbsp;: Am\u00e9liorer en continu et r\u00e9aliser la transition<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;: Conclusion<\/strong><\/p>\n<p><strong>Le\u00e7on&nbsp;: Glossaire<\/strong><\/p>\n<p><strong>\u00c9valuation finale<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019ISO 9001:2026 est la premi\u00e8re r\u00e9vision compl\u00e8te en onze ans, et tous les certificats doivent basculer d\u2019ici septembre 2029. Cinq clauses ont chang\u00e9 sur le fond : culture qualit\u00e9 et \u00e9thique, changement climatique, politique li\u00e9e \u00e0 la strat\u00e9gie, risques dissoci\u00e9s des opportunit\u00e9s, sensibilisation \u00e9largie. Cette formation en ligne de deux heures certifie vos \u00e9quipes sur [&hellip;]<\/p>\n","protected":false},"featured_media":62982,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,256,259,258],"product_tag":[],"class_list":["post-58006","product","type-product","status-publish","has-post-thumbnail","product_cat-assurance-qualite","product_cat-dispositifs-medicaux","product_cat-laboratoires","product_cat-pharmaceutique","first","instock","taxable","shipping-taxable","purchasable","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 v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 9001:2026 Syst\u00e8mes de management de la qualit\u00e9 \u2013 Cours de formation certifi\u00e9 pour les sciences de la vie<\/title>\n<meta name=\"description\" content=\"Cours certifi\u00e9 de 2\u00a0heures sur l\u2019ISO 9001:2026\u00a0: les cinq changements, la culture qualit\u00e9, le contexte climatique et la transition 2029. 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