{"id":819,"date":"2019-10-09T13:54:32","date_gmt":"2019-10-09T11:54:32","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=819"},"modified":"2026-08-20T12:23:06","modified_gmt":"2026-08-20T10:23:06","slug":"kvalitetsstyring","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/quality-management-goer-tingene-rigtigt\/kvalitetsstyring\/","title":{"rendered":"Quality Management Systems"},"content":{"rendered":"<div id=\"pl-819\"  class=\"panel-layout\" ><div id=\"pg-819-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-819-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-819-0-0-0\" class=\"so-panel widget widget_sow-image panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-dbf295114b96-819\"\n\t\t\t\n\t\t>\n<div class=\"sow-image-container\">\n\t\t<img \n\tsrc=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Kvalitetsstyringssystem-1.jpg\" width=\"1105\" height=\"468\" srcset=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Kvalitetsstyringssystem-1.jpg 1105w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Kvalitetsstyringssystem-1-300x127.jpg 300w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Kvalitetsstyringssystem-1-768x325.jpg 768w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Kvalitetsstyringssystem-1-1024x434.jpg 1024w\" sizes=\"(max-width: 1105px) 100vw, 1105px\" title=\"Kvalitetsstyringssystem\" alt=\"Kvalitetsstyringssystem\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><\/div><\/div><div id=\"pg-819-1\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-819-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-819-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<h1>Quality Management Systems<\/h1>\n<p class=\"isSelectedEnd\">Jeg hj\u00e6lper organisationer med at etablere, implementere, optimere og forenkle Quality Management Systems i regulerede life science-milj\u00f8er.<br \/>\nMin erfaring omfatter b\u00e5de opbygning af nye Quality Management Systems samt optimering, harmonisering og standardisering af eksisterende systemer og processer.<\/p>\n<h2>Omr\u00e5der, jeg kan hj\u00e6lpe med<\/h2>\n<ul data-spread=\"false\">\n<li>Etablering og implementering af Quality Management Systems<\/li>\n<li>Udvikling og implementering af procedurer og kvalitetsprocesser<\/li>\n<li>Gap assessments og compliance reviews<\/li>\n<li>Optimering og forenkling af eksisterende systemer og dokumentation<\/li>\n<li>Harmonisering og standardisering p\u00e5 tv\u00e6rs af organisationer og produktionssites<\/li>\n<li>Interne audits<\/li>\n<li>Kvalitetsstyring af leverand\u00f8rer<\/li>\n<li>Leverand\u00f8raudits<\/li>\n<li>Kvalitetsaftaler<\/li>\n<li>Styring af \u00e6ndringer<\/li>\n<li>Undervisning og vidensoverf\u00f8rsel<\/li>\n<\/ul>\n<h2>Regulatoriske krav og kvalitetsstandarder<\/h2>\n<p class=\"isSelectedEnd\">Min erfaring omfatter Quality Management Systems relateret til:<\/p>\n<ul data-spread=\"false\">\n<li>ISO 13485<\/li>\n<li>MDR og IVDR<\/li>\n<li>ISO 15378<\/li>\n<li>GMP<\/li>\n<li>Andre relevante regulatoriske krav og kvalitetskrav<\/li>\n<\/ul>\n<h2>IT-systemer til underst\u00f8ttelse af Quality Management<\/h2>\n<p class=\"isSelectedEnd\">Jeg har ogs\u00e5 erfaring med implementering af IT-systemer, der underst\u00f8tter Quality Management-processer, herunder elektroniske dokumentstyringssystemer og softwarevalidering.<br \/>\nDette omfatter blandt andet definition af krav, st\u00f8tte til implementering samt sikring af, at relevante kvalitets- og compliancekrav bliver h\u00e5ndteret p\u00e5 en passende m\u00e5de.<\/p>\n<h2>Praktiske og proportionale Quality Management Systems<\/h2>\n<p class=\"isSelectedEnd\">Et Quality Management System skal underst\u00f8tte compliance uden at skabe un\u00f8dig kompleksitet.<br \/>\nJeg tilpasser systemer og processer til organisationen, de regulatoriske krav, produkterne og organisationens modenhed med fokus p\u00e5 l\u00f8sninger, der er praktiske, effektive og anvendelige i den daglige drift.<\/p>\n<p>Hvis du \u00f8nsker at dr\u00f8fte en udfordring relateret til Quality Management Systems eller en mulig opgave, er du velkommen til at kontakte mig.<\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Quality Management Systems Jeg hj\u00e6lper organisationer med at etablere, implementere, optimere og forenkle Quality Management Systems i regulerede life science-milj\u00f8er. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":654,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-819","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality Management Systems - Borgensgaard Consulting<\/title>\n<meta name=\"description\" content=\"Kontakt mig hvis du har brug for hj\u00e6lp til etablering af et helt nyt kvalitetsstyringssystem, indf\u00f8relse af nye processer og\/eller procedurer eller lignende\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/borgensgaard-consulting.dk\/da\/quality-management-goer-tingene-rigtigt\/kvalitetsstyring\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality Management Systems - 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