{"id":10962,"date":"2024-12-11T15:10:52","date_gmt":"2024-12-11T14:10:52","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/4-qus-quality-system-qualitaetsmanagement-system\/"},"modified":"2025-02-04T13:37:58","modified_gmt":"2025-02-04T12:37:58","slug":"4-qus-quality-system-quality-management-system","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/4-qus-quality-system-qualitaetsmanagement-system\/","title":{"rendered":"4 QUS Quality System Quality management system"},"content":{"rendered":"<div class=\"wp-block-file\"><a id=\"wp-block-file--media-9f57b9b7-e683-4da6-a125-ad8898fd0555\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_01_aufgaben_qse.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/01 Tasks of the quality assurance unit<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_01_aufgaben_qse.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9f57b9b7-e683-4da6-a125-ad8898fd0555\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e153b114-69c9-4bba-8f7d-ade14ade74c2\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_verfassen_sops.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/02 Creation of VA<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_verfassen_sops.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e153b114-69c9-4bba-8f7d-ade14ade74c2\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-f55f6db4-04ed-46e3-a1bc-13a194262040\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_01_formular_va.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/02-01 Form for VA German<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_01_formular_va.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f55f6db4-04ed-46e3-a1bc-13a194262040\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-f409e95a-da2a-46b9-a407-3f3c92ba5cef\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_02_formular_va_english.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/02-02 Form for VA English<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_02_formular_va_english.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f409e95a-da2a-46b9-a407-3f3c92ba5cef\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-70fa111e-1c97-470b-8bed-b99d9c98ce83\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_03_pruefung_sop.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/02-03 Audit of a VA<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_02_03_pruefung_sop.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-70fa111e-1c97-470b-8bed-b99d9c98ce83\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-ddb7caf0-7a89-4210-a875-2f6c648e9cd0\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_03_verwaltung_sop.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/03 Management of standard operating procedures<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_03_verwaltung_sop.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ddb7caf0-7a89-4210-a875-2f6c648e9cd0\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-00718fb1-d28a-479a-a335-d899a1b84dc2\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_04_00_interne_audits.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/04 Internal audit (system audit)<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_04_00_interne_audits.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-00718fb1-d28a-479a-a335-d899a1b84dc2\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-075a1ba0-6085-44f9-98dc-5f7bb2b096e1\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_04_01_formular_auditbericht.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/04-01 Audit report form<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_04_01_formular_auditbericht.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-075a1ba0-6085-44f9-98dc-5f7bb2b096e1\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-3da49fb9-3439-4557-80a8-54de4832f528\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_05_00.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/05 Reporting QSE<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_05_00.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3da49fb9-3439-4557-80a8-54de4832f528\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-128d4309-6ef6-45e9-8890-c6daf08590c6\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_06_00_qualitaetserklaerung.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/06 Quality declaration (certificate)<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_06_00_qualitaetserklaerung.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-128d4309-6ef6-45e9-8890-c6daf08590c6\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a28f9323-212b-4260-a3f0-2a2700cfa789\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_07_00_bestandliste_geraete.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/07 Inventory list of devices<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_07_00_bestandliste_geraete.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a28f9323-212b-4260-a3f0-2a2700cfa789\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-0c70d166-9409-47ba-a4c9-cae7c0f022a9\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_08_00_fortbildungsmassnahmen.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/08 Further training measures by QSE<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_08_00_fortbildungsmassnahmen.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0c70d166-9409-47ba-a4c9-cae7c0f022a9\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-c9f830c4-4ac9-4e2b-b543-9ea3a23334ca\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_09_00_hinweise_fuer_qse_mitarbeiter.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/09 Notes on the work of QSE employees<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_09_00_hinweise_fuer_qse_mitarbeiter.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-c9f830c4-4ac9-4e2b-b543-9ea3a23334ca\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-43e99c5a-2132-45cf-bb70-0f9704081aff\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_10_00_externe_qse.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/10 External QSE<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_10_00_externe_qse.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-43e99c5a-2132-45cf-bb70-0f9704081aff\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e17c429f-7f25-4901-9fca-345f935e947d\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_10_01_rahmenvertrag.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/10-01 Framework agreement<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_10_01_rahmenvertrag.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e17c429f-7f25-4901-9fca-345f935e947d\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-46ab6a6c-decb-423d-838a-a7d74b3559b6\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_11_00_verwaltung_anerkannte_regeln.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/11 Management of the \"Recognised rules\"<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_11_00_verwaltung_anerkannte_regeln.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-46ab6a6c-decb-423d-838a-a7d74b3559b6\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-56a57027-155e-473c-a5d6-bd4cda8611c0\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_12_00_glossar.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/12 Creation of a glossary<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_12_00_glossar.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-56a57027-155e-473c-a5d6-bd4cda8611c0\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-5af30f19-fcc6-4254-92a6-382d25019471\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_13_00_literatursammlung.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/13 Literature collection<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_13_00_literatursammlung.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5af30f19-fcc6-4254-92a6-382d25019471\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-45484c59-c5d4-4e9b-8611-14658e28b732\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_14_masterschedule.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/14 Maintaining a Master Schedule<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_14_masterschedule.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-45484c59-c5d4-4e9b-8611-14658e28b732\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-cfca3c21-763c-42af-829e-0a38af1391eb\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_14_01_formular_master_schedule.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">QUS\/14-01 Form Master Schedule<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/qse_14_01_formular_master_schedule.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-cfca3c21-763c-42af-829e-0a38af1391eb\">Download<\/a><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":10954,"menu_order":4,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10962","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\/10962","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=10962"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10962\/revisions"}],"predecessor-version":[{"id":15044,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10962\/revisions\/15044"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10954"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=10962"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10962"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}