{"id":10462,"date":"2024-12-11T11:26:50","date_gmt":"2024-12-11T10:26:50","guid":{"rendered":"https:\/\/extali.eu\/docs\/3-krankenhausleitung\/3-5-beschaffung\/3-5-07-vereinbarung-zur-qualitaetsdarlegung\/"},"modified":"2025-08-07T11:43:03","modified_gmt":"2025-08-07T09:43:03","slug":"3-5-07-agreement-on-quality-presentation","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/3-krankenhausleitung\/3-5-beschaffung\/3-5-07-vereinbarung-zur-qualitaetsdarlegung\/","title":{"rendered":"3.5.07 Agreement on quality presentation"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Goal and purpose<\/h2>\n\n\n\n<p>The management must stipulate that only products for which proof of manufacture, e.g. in accordance with GMP, or proof of conformity, e.g. in accordance with the MPG, is available are procured. For most quality-relevant products, such as medicines, blood products and devices, all suppliers to a hospital, including their subcontractors, are required by law to provide QM documentation (see German Medicines Act, Medical Devices Act).<\/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<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 Die Leitung muss festlegen, dass nur Produkte beschafft werden, f\u00fcr die ein Herstellungsnachweis, z.B. entsprechend GMP, oder ein Konformit\u00e4tsnachweis, z.B. nach MPG, vorliegt. F\u00fcr die meisten qualit\u00e4tsrelevanten Produkte, wie Arzneimittel, Blutprodukte und Ger\u00e4te, sind alle Lieferanten eines Krankenhauses einschlie\u00dflich ihrer Unterauftragnehmer aufgrund gesetzlicher Bestimmungen zur QM-Darlegung verpflichtet (vgl. Arzneimittelgesetz, Medizinproduktegesetz). Anwendung Beschreibung [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10448,"menu_order":129,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10462","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\/10462","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=10462"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10462\/revisions"}],"predecessor-version":[{"id":14715,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10462\/revisions\/14715"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10448"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=10462"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10462"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}