{"id":11024,"date":"2024-12-11T15:17:07","date_gmt":"2024-12-11T14:17:07","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-15-einfuehrung-neuer-oder-geaenderter-produkte\/"},"modified":"2025-02-04T13:38:12","modified_gmt":"2025-02-04T12:38:12","slug":"5-2-15-introduction-de-nouveaux-produits-ou-de-produits-modifies","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-15-einfuehrung-neuer-oder-geaenderter-produkte\/","title":{"rendered":"5.2.15 Lancement de nouveaux produits ou de produits modifi\u00e9s"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">But et objectif<\/h2>\n\n\n\n<p>L'introduction de nouveaux produits et de produits modifi\u00e9s doit faire l'objet d'une concertation au sein de l'organisation. Les besoins en formation doivent \u00eatre d\u00e9termin\u00e9s et la mise \u00e0 disposition des ressources doit \u00eatre v\u00e9rifi\u00e9e. Les exigences en mati\u00e8re d'enregistrement doivent \u00eatre d\u00e9finies et int\u00e9gr\u00e9es dans le SIH. La communication tout au long du processus doit \u00eatre assur\u00e9e. Informer le personnel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Application<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description du d\u00e9roulement<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risques<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Ressources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Mat\u00e9riau<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Temps n\u00e9cessaire<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentation<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Comp\u00e9tence et qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Remarques et commentaires<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documents \u00e0 joindre<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documents de validation<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Termes<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Placements<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel Die Einf\u00fchrung neuer und ge\u00e4nderter Produkte muss inner-halb der Organisation umfassen abgestimmt werden. Der Schulungsbedarf ist festzulegen, die Bereitstellung der Res-sourcen muss \u00fcberpr\u00fcft werden. Die Anforderungen an die Aufzeichnungen m\u00fcssen festgelegt und in das KIS integriert werden. Die Kommunikation entlang des Prozessverlaufes muss gesichert werden. Information der Mitarbeiter. Anwendung Beschreibung des Ablaufes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":50,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11024","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11024","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/comments?post=11024"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11024\/revisions"}],"predecessor-version":[{"id":15105,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11024\/revisions\/15105"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/media?parent=11024"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_tag?post=11024"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_badge?post=11024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}