{"id":11074,"date":"2024-12-11T15:21:11","date_gmt":"2024-12-11T14:21:11","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-15-berichte-ueber-ues-an-die-leitung\/"},"modified":"2025-02-04T13:38:24","modified_gmt":"2025-02-04T12:38:24","slug":"5-3-15-reports-on-ues-to-the-management","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-15-berichte-ueber-ues-an-die-leitung\/","title":{"rendered":"5.3.15 Reports on UEs to the management"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>Clear presentation of reports on adverse events, incidents involving medical devices, (occupational) accidents, special incidents, results of the evaluation of reporting registers, results of hazard analyses, alerts, complaints and claims. The report should be submitted to the management during the annual management review. When setting quality targets, a certain number of e.g. 10 safety targets for the following period and corresponding preventive measures are derived after weighting (see 5.4.03).<\/p>\n\n\n\n<p><em>DIN EN ISO 9001:2015 and DIN EN 15224:2017 8.7.2; QM-RL:2015 \u00a7 4 (1) - -error management systems, sentence 7<\/em> <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Area of application<\/h2>\n\n\n\n<p>Annual reports from the QM coordinator to the management <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description of the<\/h2>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-da5772ba-53fc-42de-ba60-2b21953da37a\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.15_00_qm_jahresbericht_ereignisse.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">to the process instruction here <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.15_00_qm_jahresbericht_ereignisse.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-da5772ba-53fc-42de-ba60-2b21953da37a\">Download<\/a><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel \u00dcbersichtliche Darstellung der Berichte \u00fcber Unerw\u00fcnschte Ereignisse, Vorkommnisse mit Medizinprodukten, (Arbeits)-Unf\u00e4lle, Besondere Vorkommnisse, Ergebnisse der Auswertung von Melderegistern, Ergebnisse der Gefahrenanalyse, Warnmeldungen, Reklamationen und Beschwerden. Der Bericht soll der Leitung bei der j\u00e4hrlichen Manage-mentbewertung vorgelegt werden. Bei der Setzung von Qualit\u00e4tsziele werden nach Gewichtung eine bestimmte Zahl von z. B. 10 Sicherheitszielen [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":11044,"menu_order":74,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11074","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\/11074","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=11074"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11074\/revisions"}],"predecessor-version":[{"id":15126,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11074\/revisions\/15126"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11044"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11074"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11074"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}