{"id":885,"date":"2019-10-10T14:43:56","date_gmt":"2019-10-10T12:43:56","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=885"},"modified":"2026-08-20T12:39:03","modified_gmt":"2026-08-20T10:39:03","slug":"risikostyring","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/quality-management-goer-tingene-rigtigt\/risikostyring\/","title":{"rendered":"Risikostyring"},"content":{"rendered":"
\n
\n\t\t\"Risikostyring\"\n\t<\/div>\n\n<\/div><\/div><\/div><\/div>
\n
\n\t

Risikostyring<\/h1>\n

Risikostyring er en v\u00e6sentlig del af Quality Management og regulatorisk compliance og b\u00f8r v\u00e6re integreret i relevante processer p\u00e5 tv\u00e6rs af R&D, Operations og Quality.
\nJeg har omfattende erfaring med b\u00e5de produkt- og procesrisikostyring i regulerede life science-milj\u00f8er og kan hj\u00e6lpe organisationer med at etablere, forbedre og anvende risikobaserede tilgange i praksis.<\/p>\n

Omr\u00e5der, jeg kan hj\u00e6lpe med<\/h2>\n
    \n
  • Produktrisikostyring<\/li>\n
  • Procesrisikostyring<\/li>\n
  • Facilitering og dokumentation af FMEA<\/li>\n
  • Risikovurderinger i forbindelse med \u00e6ndringer<\/li>\n
  • Risikovurderinger af leverand\u00f8rer og outsourcede processer<\/li>\n
  • Etablering og forbedring af risikostyringsprocesser<\/li>\n
  • Integration af risikostyring i Quality Management System-processer<\/li>\n
  • Undervisning og facilitering af tv\u00e6rfunktionelle risikostyringsaktiviteter<\/li>\n<\/ul>\n

    Produktrisikostyring<\/h2>\n

    Inden for medicinsk udstyr og IVD har jeg erfaring med risikostyringsaktiviteter som en del af Design Control og relaterede aktiviteter gennem produktets livscyklus.
    \nDette omfatter samarbejde med tv\u00e6rfunktionelle teams om at identificere farer, vurdere risici, definere relevante risikokontroller samt sikre, at risikostyringsaktiviteter dokumenteres korrekt og integreres med relevant Design Control-dokumentation.<\/p>\n

    Procesrisikostyring<\/h2>\n

    Jeg har desuden omfattende erfaring med risikostyring relateret til produktions- og operationelle processer.
    \nDette omfatter facilitering af proces-FMEA, identifikation og vurdering af procesrisici, definition af relevante kontroller samt opf\u00f8lgning p\u00e5 risikoreducerende tiltag.
    \nMin erfaring omfatter en bred vifte af produktions- og emballeringsprocesser og g\u00f8r mig i stand til at facilitere risikostyringsaktiviteter i samarbejde med Operations, Engineering, Quality og andre relevante funktioner.<\/p>\n

    Integreret risikostyring<\/h2>\n

    Risikostyring b\u00f8r ikke v\u00e6re en isoleret aktivitet.
    \nJeg fokuserer p\u00e5 at integrere risikobaseret t\u00e6nkning i relevante Quality Management System-processer som Design Control, Change Control, Supplier Management og andre aktiviteter, hvor risikovurderinger underst\u00f8tter effektiv beslutningstagning.
    \nM\u00e5let er at sikre, at niveauet af kontrol og dokumentation st\u00e5r i rimeligt forhold til den faktiske risiko, og at risikostyring anvendes p\u00e5 en praktisk og konsistent m\u00e5de.<\/p>\n

    Regulatoriske krav og kvalitetsstandarder<\/h2>\n

    Min erfaring omfatter risikostyringsaktiviteter i henhold til:<\/p>\n

      \n
    • ISO 14971<\/li>\n
    • ISO 13485<\/li>\n<\/ul>\n

      Disse standarder underst\u00f8tter compliance med relevante krav til risikostyring i MDR og IVDR.<\/p>\n

      Hvis du \u00f8nsker at dr\u00f8fte en udfordring inden for risikostyring eller en mulig opgave, er du velkommen til at kontakte mig.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

      Risikostyring Risikostyring er en v\u00e6sentlig del af Quality Management og regulatorisk compliance og b\u00f8r v\u00e6re integreret i relevante processer p\u00e5 […]<\/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-885","page","type-page","status-publish","hentry"],"yoast_head":"\nRisikostyring - Borgensgaard Consulting<\/title>\n<meta name=\"description\" content=\"Risikostyring af processer, som har eller kan have indflydelse p\u00e5 kvaliteten af produkter og serviceydelser, er meget v\u00e6sentlig.\" \/>\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\/risikostyring\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risikostyring - 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