{"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":"2026-08-13T09:51:32","modified_gmt":"2026-08-13T07:51:32","slug":"audits-voor-medische-hulpmiddelen","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/audits-voor-medische-hulpmiddelen\/","title":{"rendered":"Audits voor medische hulpmiddelen"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;bottom&#8221; bg_color=&#8221;bg_purple&#8221; bg_fade=&#8221;fade_white&#8221; css=&#8221;.vc_custom_1670580737571{background-image: url(https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/home_banner.jpg?id=505) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column width=&#8221;7\/12&#8243;]\r\n        <div class=\"sd-block-breadcrumb  align-left marginbottom-20px\r\n        \">\r\n            <ul id=\"breadcrumbs\" class=\"breadcrumbs\">\r\n            <li class=\"item-home\"><a class=\"bread-link bread-home\" href=\"https:\/\/www.biotopmedical.nl\/nl\/\" title=\"Home\">Home<\/a><\/li>\r\n            <li class=\"separator separator-home\"> > <\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple\r\n            \">Audits voor medische hulpmiddelen<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-40px align-left color-purple bg bg-white\r\n            \">Onafhankelijke auditondersteuning voor je QMS<\/h2>\r\n        <\/div>[\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;5\/12&#8243;]\r\n            <a class=\"sd-block-cta  marginbottom-0px white duocolor\" title=\"Laat ons je volgende audit ondersteunen\" href=\"#contact\"\r\n                >\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" version=\"1.1\" id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 232.2 126.4\" style=\"enable-background:new 0 0 232.2 126.4;\" xml:space=\"preserve\"> <style type=\"text\/css\"> .st0{fill:#5B358C;} .st1{fill:#E42313;} .st2{fill:#FFFFFF;} <\/style> <g> <polygon class=\"st0\" points=\"0,62.3 0,17 113.5,17 113.5,53.9 232.2,53.9 232.2,99.2 105.9,99.2 105.9,62.3 \"><\/polygon> <path class=\"st1\" d=\"M147.9,11.4c0,0-6.7,0.6-11.1-0.7c-2.7-0.9-5.3-3.3-8.2-2.8c-4.5,0.8-8.7,2.4-10.7,6.8 c-1.6,3.4-1.6,8.3,4.1,15.1c5.7,6.7,9.4,14,5.8,21.9c-3.3,7.2-10.3,9.4-18.3,9.7c-8,0.3-13.3,3-15.2,7.2c-1.7,3.7-0.8,9.7,2.3,15.7 c2.7,5.2,8.3,15.2,5.5,21.1c-6,12.4-23.3,21.1-23.3,21.1l-0.2-0.2c0,0,15.7-13.3,17.7-23.3c0.6-3.1-1.5-9.6-5.2-16 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           <h2 class=\"sd-block-title-htag  marginbottom-0px align-left color-white bg bg-purple\r\n            \">Laat ons je volgende audit ondersteunen<\/h2>\r\n        <\/div>\r\n                        <div class=\"cta-content\">\r\n                            \r\n        <div class=\"sd-block-text  marginbottom-40px color-black\r\n        \">\r\n            <p>Of het nu om een notified body audit, een leveranciersaudit of een interne audit gaat: onze auditors zijn getraind volgens ISO 19011 en kunnen je voorbereiden, je op de dag zelf ondersteunen, of de audit volledig van je overnemen. Neem contact op om te bespreken wat je nodig hebt.<\/p>\n\r\n        <\/div>\r\n                            \r\n        <div class=\"sd-block-button  marginbottom-0px style-transparent color-purple\">\r\n            <span href=\"\" title=\"Neem contact op\">Neem contact op<\/span>\r\n        <\/div>\r\n                        <\/div>\r\n                    \r\n            <\/a>[\/vc_column][\/vc_row][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;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Een onafhankelijke auditor vinden voor je QMS is niet eenvoudig, zeker niet met de training- en certificeringseisen die bij die rol horen. Notified body audits geven extra druk: ze zijn vaak uitgebreid, en een goede voorbereiding vraagt om echte auditervaring. De auditors van Biotop Medical zijn getraind volgens ISO 19011 en hebben de certificeringen om je te ondersteunen bij notified body audits, leveranciersaudits en interne audits.<br \/>\nOf je nu wilt dat wij de audit voor je uitvoeren, je erop voorbereiden, of vooraf je opzet beoordelen: we passen ons aan wat jij nodig hebt.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-40px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Onze auditdiensten<\/h2>\r\n        <\/div>[vc_row_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Ondersteuning bij notified body audits<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Notified body audits zijn meestal de meest uitgebreide audits die je QMS te wachten staan. We helpen je in de maanden vooraf met de voorbereiding, lopen samen met jou door je documentatie, en ondersteunen je op de dag zelf, zodat je niet voor verrassingen komt te staan.<br \/>\nKomen er tijdens de audit tekortkomingen naar boven, dan helpen we je met het opstellen van de reactie en het sluiten daarvan binnen de termijn die de notified body stelt.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Leveranciersaudit voor medische hulpmiddelen<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Ook je leveranciers maken deel uit van je kwaliteitssysteem, en ISO 13485 verwacht dat je daar zicht op houdt. Wij voeren de leveranciersaudits namens jou uit, met een checklist die is opgebouwd rond de risico&#8217;s die specifiek zijn voor jouw hulpmiddel en je toeleveringsketen.<br \/>\nZo heb je gedocumenteerd bewijs van toezicht op je leveranciers, zonder dat je hiervoor zelf auditcapaciteit moet opbouwen.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Interne audit voor medische hulpmiddelen<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>ISO 13485 vereist dat je regelmatig interne audits uitvoert, en de auditor moet onafhankelijk zijn van het proces dat wordt beoordeeld. Dat is lastig te regelen in een klein team waar iedereen overal de handen in heeft.<br \/>\nWij nemen die interne auditrol voor je over, zodat aan de onafhankelijkheidseis wordt voldaan en je een \u00e9cht frisse blik op je QMS krijgt.<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][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            \">Services<\/h3>\r\n        <\/div><ul><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/\">Quality Management System<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\/?page_id=65\">QMS Implementation<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\/quality-management-system\/medical-device-auditing\/\">Medical device auditing<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\/technical-documentation\/\">Technical Documentation File<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\/technical-documentation\/medical-device-risk-management\/\">Medical device risk management<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\/technical-documentation\/clinical-evaluation-mdr\/\">Clinical Evaluation &#038; MDR<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\/technical-documentation\/systematic-literature-searches\/\">Systematic Literature Searches<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\/technical-documentation\/biological-safety-assessment\/\">Biological Evaluation<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\/technical-documentation\/other\/\">Other<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\/person-responsible-for-regulatory-compliance\/\">Person Responsible for Regulatory Compliance<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\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/09\/Logo_BioTop.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 direct contact bel<br \/>\n+31 (0)71 528 01 12<br \/>\nVragen? Neem contact op<br \/>\ninfo@biotopmedical.nl<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1786456150269{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;contact&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;7\/12&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Neem contact op!<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Ben je benieuwd hoe een audit met Biotop Medical eruit zou zien? Neem contact op voor een gratis, vrijblijvend gesprek. We helpen je graag.<\/p>\n\r\n        <\/div>\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f10-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"10\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/nl\/wp-json\/wp\/v2\/pages\/661#wpcf7-f10-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\" data-form-name=\"Contact form 1\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"10\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.6\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f10-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/>\n<\/fieldset>\n<div class=\"wpcf7-turnstile cf-turnstile\" data-sitekey=\"0x4AAAAAAB6h3BBYj4Y23Mpu\" data-response-field-name=\"_wpcf7_turnstile_response\"><\/div>\n\n<div class=\"sd-form\">\n\t<div class=\"input-row\">\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"firstName\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Name *\" value=\"\" type=\"text\" name=\"firstName\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"companyName\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Company name *\" value=\"\" type=\"text\" name=\"companyName\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email*\" value=\"\" type=\"email\" name=\"email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"tel\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-text wpcf7-validates-as-tel\" aria-invalid=\"false\" placeholder=\"Phone\" value=\"\" type=\"tel\" name=\"tel\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input-col-120\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"message\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Please let us know your question *\" name=\"message\"><\/textarea><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input-col-120\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"checkbox-922\"><span class=\"wpcf7-form-control wpcf7-checkbox wpcf7-validates-as-required\"><span class=\"wpcf7-list-item first last\"><label><input type=\"checkbox\" name=\"checkbox-922[]\" value=\"Yes, I agree to the\" \/><span class=\"wpcf7-list-item-label\">Yes, I agree to the<\/span><\/label><\/span><\/span><\/span><span class=\"privacy-acceptance-link\"><a href=\"\/privacy-policy\/\" target=\"_blank\"> privacy statement<\/a><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<p><button type=\"submit\" class=\"has-spinner\">Send<\/button>\n\t\t<\/p>\n\t<\/div>\n<\/div>\r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_email_address_2_value\" class=\"SD-label \">Confirm email address<\/label>\r\n            <input type=\"text\" name=\"email_address_2_value\" id=\"apply_form_email_address_2_value\" class=\"SD-input  email_address_2_value\" placeholder=\"\" value=\"\" style=\"display: none;\">\r\n        <\/div>\r\n        \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_additional_comments_value\" class=\"SD-label \">Additional comments<\/label>\r\n            <textarea name=\"additional_comments_value\" id=\"apply_form_additional_comments_value\" class=\"SD-input  additional_comments_value\" style=\"display: none;\" placeholder=\"\">Please fill in your additional comments<\/textarea>\r\n        <\/div>\r\n    \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_city_home_value\" class=\"SD-label \">City<\/label>\r\n            <input type=\"hidden\" name=\"city_home_value\" id=\"apply_form_city_home_value\" class=\"SD-input  city_home_value\" placeholder=\"\" value=\"\">\r\n        <\/div>\r\n    \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_more_additional_comments_value\" class=\"SD-label \">More additional comments<\/label>\r\n            <input type=\"hidden\" name=\"more_additional_comments_value\" id=\"apply_form_more_additional_comments_value\" class=\"SD-input  more_additional_comments_value\" placeholder=\"\" value=\"Please fill in your additional comments\">\r\n        <\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n[\/vc_column_inner][vc_column_inner width=&#8221;1\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Waarom BioTop Medical?<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-usp  marginbottom-20px\r\n        \">\r\n            <div class=\"usp-inner\">\r\n                <div class=\"usp-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 448 512\"><path fill=\"currentColor\" d=\"M438.6 105.4C451.1 117.9 451.1 138.1 438.6 150.6L182.6 406.6C170.1 419.1 149.9 419.1 137.4 406.6L9.372 278.6C-3.124 266.1-3.124 245.9 9.372 233.4C21.87 220.9 42.13 220.9 54.63 233.4L159.1 338.7L393.4 105.4C405.9 92.88 426.1 92.88 438.6 105.4H438.6z\"\/><\/svg><\/div>\r\n                <div class=\"usp-text\">Auditors, getraind volgens ISO 19011, die QMS voor medische hulpmiddelen door en door kennen<\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Vragen? Neem contact op<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor direct contact bel<br \/>\n+31 (0)71 528 01 12<br \/>\nJe kan ons ook mailen<br \/>\ninfo@biotopmedical.nl<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;bg_lightpurple&#8221; css=&#8221;.vc_custom_1745844621633{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Veelgestelde vragen over auditing<\/h2>\r\n        <\/div>[vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat is een interne audit?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Een interne audit is een periodieke controle van je eigen kwaliteitsmanagementsysteem, uitgevoerd door iemand die onafhankelijk is van het proces dat wordt beoordeeld. ISO 13485 vereist dat je deze audits regelmatig uitvoert, zodat je problemen ontdekt voordat een externe auditor dat doet.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat is een leveranciersaudit?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Een leveranciersaudit controleert of een van je leveranciers, zoals een onderdelenfabrikant of contractfabrikant, werkt volgens de kwaliteitseisen waar jij op vertrouwt. ISO 13485 verwacht dat je zicht houdt op je kritieke leveranciers, en een leveranciersaudit is hoe je dat documenteert.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat is een notified body audit?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Een notified body audit wordt uitgevoerd door de organisatie die je QMS certificeert en je hulpmiddelen voorziet van de CE-markering onder de MDR of IVDR. Het is meestal de grondigste audit die je bedrijf doorloopt, en deze bepaalt of je certificering geldig blijft.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Hoe lang duurt een audit?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Dat hangt af van het type audit en de omvang van je QMS. Een interne audit of leveranciersaudit duurt meestal een dag. Een notified body audit kan meerdere dagen in beslag nemen, afhankelijk van hoeveel processen en locaties binnen de scope vallen.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;bottom&#8221; bg_color=&#8221;bg_purple&#8221; bg_fade=&#8221;fade_white&#8221; css=&#8221;.vc_custom_1670580737571{background-image: url(https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/home_banner.jpg?id=505) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column width=&#8221;7\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;5\/12&#8243;][\/vc_column][\/vc_row][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;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1786456150269{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;contact&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;7\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;bg_lightpurple&#8221; &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/audits-voor-medische-hulpmiddelen\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Audits voor medische hulpmiddelen&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":660,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-661","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Audits voor medische hulpmiddelen | BioTop Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/audits-voor-medische-hulpmiddelen\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Audits voor medische hulpmiddelen | BioTop Medical\" \/>\n<meta property=\"og:description\" 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