{"id":661,"date":"2022-08-10T15:11:45","date_gmt":"2022-08-10T13:11:45","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/quality-management-system\/auditing\/"},"modified":"2024-04-30T11:06:06","modified_gmt":"2024-04-30T09:06:06","slug":"auditen","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/auditen\/","title":{"rendered":"Auditen"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;]\r\n        <div class=\"sd-block-menu  marginbottom-40px\r\n        \">\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-black\r\n            \">Diensten<\/h3>\r\n        <\/div><ul><li class=\"menu-item current-parent\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/\">Kwaliteits management systeem<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><ul class=\"sub-menu\"><li class=\"sub-menu-item current-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/auditen\/\">Auditen<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/qms-implementatie\/\">QMS implementatie<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/\">Technische Documentatie<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><ul class=\"sub-menu\"><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/risicomanagement\/\">Risicomanagement<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/klinische-evaluatie\/\">Klinische \/ Prestatie evaluatie<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/systematisch-literatuuronderzoek\/\">Systematisch literatuuronderzoek<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/biologisch-evaluatierapport\/\">Biologische Evaluatie<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/overig\/\">Overig<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/nl\/persoon-verantwoordelijk-voor-de-naleving-van-de-regelgeving\/\">Person Responsible for Regulatory Compliance (PRRC)<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-image  align-center marginbottom-40px snake-icon\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/08\/snake-icon-v2-1.svg\" width=\"600\" height=\"500\">\r\n        <\/div>[vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor rechtstreeks contact belt u<br \/>\n<a href=\"tel:+31715280112\">+31 (0)71 528 01 12<\/a><strong><br \/>\n<\/strong><\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-black bg bg-lightpurple font-middle\r\n            \">Diensten<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-40px align-left color-white bg bg-purple font-middle\r\n            \">Auditen<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Auditen vereist uitgebreide kennis en ervaring, waaronder een &#8220;kritische blik&#8221; om (mogelijke) non-conformiteiten te identificeren, wat voor fabrikanten niet altijd een gemakkelijke taak om te vervullen is. Dankzij onze ervaring met auditen zijn wij in staat om onafhankelijke beoordelingen, volledige en duidelijke auditrapporten, advies over mogelijke verbeteracties en hulp bij het plannen van vervolgacties te verstrekken.<\/p>\n<p>Een basisvereiste voor een QMS van een gecertificeerd bedrijf voor medische hulpmiddelen is dat een auditor zijn eigen werk <span style=\"text-decoration: underline;\">niet<\/span> mag doorlichten. Dit betekent vaak dat interne audits niet door het bedrijf zelf maar door een externe partij worden uitgevoerd. Dit speelt met name bij kleine en middelgrote bedrijven.<\/p>\n\r\n        <\/div>[vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1669217899839{padding-right: 0px !important;}&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>In onze rol als auditor helpen wij u om uw kwaliteits- managementsysteem te verbeteren of om mogelijke problemen op te sporen, waardoor uw (her)certificering door de notified body makkelijker zal verlopen. Daarbij komt dat het merendeel van de fabrikanten van medische hulpmiddelen hun ontwikkelings- en productieprocessen uitbesteedt aan gespecialiseerde onderaannemers. Fabrikanten blijven echter volledig verantwoordelijk voor de hulpmiddelen die zij onder hun eigen naam op de markt brengen. De onderaannemers en andere gerelateerde essenti\u00eble leveranciers moeten regelmatig worden beoordeeld en dit betekent vaak dat een audit nodig is. Wij lichten de leveranciers door namens de fabrikant en beoordelen of zij voldoen aan de verplichtingen zoals vastgelegd in de kwaliteitsovereenkomst tussen beide partijen.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-button  marginbottom-40px style-solid color-purple\">\r\n            <a href=\"https:\/\/www.biotopmedical.nl\/nl\/neem-contact-met-ons-op\/\" title=\"Neem contact op\">Neem contact op<\/a>\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-image  align-Left marginbottom-40px\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/auditing.jpg\" width=\"600\" height=\"500\">\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; 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