{"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-introduccion-de-productos-nuevos-o-modificados","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/es\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-15-einfuehrung-neuer-oder-geaenderter-produkte\/","title":{"rendered":"5.2.15 Introducci\u00f3n de productos nuevos o modificados"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Finalidad y objetivo<\/h2>\n\n\n\n<p>La introducci\u00f3n de productos nuevos y modificados debe coordinarse exhaustivamente dentro de la organizaci\u00f3n. Deben definirse los requisitos de formaci\u00f3n y comprobarse la dotaci\u00f3n de recursos. Los requisitos de los registros deben definirse e integrarse en el HIS. Debe garantizarse la comunicaci\u00f3n a lo largo del flujo del proceso. Informaci\u00f3n para los empleados.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Aplicaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Descripci\u00f3n del proceso<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Riesgos<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Recursos <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Tiempo necesario<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Responsabilidad y cualificaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notas y comentarios<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documentos aplicables<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documentos de validaci\u00f3n<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">T\u00e9rminos<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Archivos adjuntos<\/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\/es\/wp-json\/wp\/v2\/docs\/11024","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/comments?post=11024"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11024\/revisions"}],"predecessor-version":[{"id":15105,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11024\/revisions\/15105"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/media?parent=11024"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_tag?post=11024"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_badge?post=11024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}