{"id":10996,"date":"2024-12-11T15:13:34","date_gmt":"2024-12-11T14:13:34","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-01-evaluationsprogramm\/"},"modified":"2025-02-04T13:38:06","modified_gmt":"2025-02-04T12:38:06","slug":"5-2-01-evaluation-programme","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-01-evaluationsprogramm\/","title":{"rendered":"5.2.01 Evaluation programme"},"content":{"rendered":"<div class=\"wp-block-file\"><a id=\"wp-block-file--media-5a49f7f5-907d-4bff-bd42-f9e74c7f1687\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.01_00_qm_evaluationsprogramm.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Download the VA as PDF <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.01_00_qm_evaluationsprogramm.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5a49f7f5-907d-4bff-bd42-f9e74c7f1687\">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>Develop, implement and maintain an evaluation programme (development process) to demonstrate the quality of the services provided on an ongoing basis. The scope, organisation, range, control and documented information are defined. <\/p>\n\n\n\n<p>Definition of the development phases, risk assessment, evaluation procedures (validation, verification), responsibilities and authorisations for development, management of the departments involved in development. Determination and recording of development inputs, development evaluation, release.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Area of application<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Integration of new and existing processes into an established quality management system,<\/li>\n\n\n\n<li>Application of new procedures\/methods in established clinical processes, e.g. the introduction of robotics in surgery and telemedicine,<\/li>\n\n\n\n<li>Reorganisation of clinical processes as a result of demand-driven performance, e.g. vaccination during pandemics,<\/li>\n\n\n\n<li>Reorganisation of processes due to unsatisfactory results, e.g. high rate of post-operative infections,<\/li>\n\n\n\n<li>Reorganisation of clinical processes as a result of serious adverse events, e.g. increase in drug-related side effects,<\/li>\n\n\n\n<li>Design of clinical trials<\/li>\n<\/ul>\n\n\n\n<p>(according to 7.3.1 note 2 of DIN EN 15224)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description of the<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Resources<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"risiken\">Risks<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">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\">Literature<\/h4>\n\n\n\n<p>BGB \u00a7 630 a para. 2; <a>DIN EN ISO 9001:2015 and DIN EN 15224:2017 8.3;<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Terms<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>\n\n\n\n<p>Annual development plan<br>Development teams<br>Conflicts of interest<\/p>","protected":false},"excerpt":{"rendered":"<p>Ziel und Zweck Erarbeiten, Umsetzen und Aufrechterhalten eines Evalutionsprogramms (Entwicklungsprozess), um die Qualit\u00e4t der Dienstleistungen, die fortlaufend erbracht werden, darzulegen. Umfang, Organisation, Reichweite, Steuerung und dokumentierte Information werden festgelegt. Festlegung der Entwicklungsphasen, Risikobewertung, Bewertungsverfahren (Validierung, Verifizierung), Verantwortungen und Befugnisse f\u00fcr die Entwicklung, Lenkung der an der Entwicklung beteiligten Abteilungen. Ermittlung und Aufzeichnung der Entwicklungseingaben, Entwicklungsbewertung, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":36,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10996","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\/10996","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=10996"}],"version-history":[{"count":3,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10996\/revisions"}],"predecessor-version":[{"id":15077,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10996\/revisions\/15077"}],"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=10996"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10996"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10996"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}