{"id":10998,"date":"2024-12-11T15:13:43","date_gmt":"2024-12-11T14:13:43","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-02-design-planung-entwicklungseingaben\/"},"modified":"2025-02-04T13:38:06","modified_gmt":"2025-02-04T12:38:06","slug":"5-2-02-design-planning-development-inputs","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-02-design-planung-entwicklungseingaben\/","title":{"rendered":"5.2.02 Design planning (development inputs)"},"content":{"rendered":"<div class=\"wp-block-file\"><a id=\"wp-block-file--media-3ac788c0-0d8f-4865-9871-b0a6d0be0f95\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.02_00_qm_designplanung_entwicklungseingaben_.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Download the VA as PDF <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.02_00_qm_designplanung_entwicklungseingaben_.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3ac788c0-0d8f-4865-9871-b0a6d0be0f95\">Download<\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Goal and purpose<\/h2>\n\n\n\n<p>Determination of the requirements that are essential for the respective product and service types.<\/p>\n\n\n\n<p>Inputs must be appropriate, complete and unambiguous for the development purposes. Contradictory development inputs must be eliminated.<\/p>\n\n\n\n<p>Requirements for the documentation of development inputs.<\/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 of the process<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risks<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Resources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Time required<\/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\">Responsibility and qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Validation documents<\/h4>\n\n\n\n<p>DIN EN ISO 9001:2015 and DIN EN 15224:2017 8.3;<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Terms<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Ziel und Zweck Bestimmung der Anforderungen, die f\u00fcr die jeweiligen Produkt- und Dienstleistungsarten von wesentlicher Bedeutung sind. Eingaben m\u00fcssen f\u00fcr die Entwicklungszwecke angemessen, vollst\u00e4ndig und eindeutig sein. Widerspr\u00fcchliche Entwick-lungseingaben m\u00fcssen beseitigt werden. Anforderungen an die Dokumentation der Entwicklungseingaben. Anwendung Beschreibung des Ablaufes Risiken Ressourcen Material Zeitbedarf Dokumentation Zust\u00e4ndigkeit und Qualifikation Hinweise und Anmerkungen Mitgeltende Unterlagen [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":37,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10998","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\/en\/wp-json\/wp\/v2\/docs\/10998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=10998"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10998\/revisions"}],"predecessor-version":[{"id":15078,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10998\/revisions\/15078"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=10998"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10998"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}