{"id":662,"date":"2022-08-10T15:11:34","date_gmt":"2022-08-10T13:11:34","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/quality-management-system\/qms-implementation\/"},"modified":"2024-03-13T09:56:01","modified_gmt":"2024-03-13T08:56:01","slug":"qms-implementatie","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/kwaliteitsmanagementsysteem\/qms-implementatie\/","title":{"rendered":"QMS implementatie"},"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  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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 current-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 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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            \">Eisen aan het kwaliteitssysteem<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p><img decoding=\"async\" class=\"wp-image-510 alignright\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/QMS_Implementation-300x250.jpg\" alt=\"\" width=\"430\" height=\"358\" srcset=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/QMS_Implementation-300x250.jpg 300w, https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/QMS_Implementation-400x334.jpg 400w, https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/QMS_Implementation.jpg 515w\" sizes=\"(max-width: 430px) 100vw, 430px\" \/>De EN ISO 13485 versie uit 2016 is de meest recente herziening van deze internationale norm die wordt toegepast door veel bedrijven van medische hulpmiddelen binnen de EU en daarbuiten. De norm beschrijft de vereisten die gebruikt kunnen worden door bedrijven die betrokken zijn bij \u00e9\u00e9n of meer stadia van de levenscyclus van een medisch hulpmiddel, waaronder ontwerp en ontwikkeling, productie, opslag en distributie, onderhoud en uiteindelijke ontmanteling en vernietiging van medische hulpmiddelen of het leveren van bijbehorende diensten (bijvoorbeeld technische ondersteuning). De vereisten van deze norm komen overeen met die van de verordening (op het gebied van medische hulpmiddelen) in de landen die de norm toepassen.<\/p>\n<p>BioTop Medical helpt klanten bij de opzet, vernieuwing, verbetering en het onderhoud van hun kwaliteitsmanagementsysteem door:<\/p>\n<ul>\n<li>Het verstrekken van de nodige informatie en begeleiding;<\/li>\n<li>Het ontwikkelen en implementeren van het systeem op projectbasis, inclusief de benodigde opleiding van het personeel;<\/li>\n<li>Praktijkgerichte ondersteuning (bijvoorbeeld opstellen, beoordelen van kwaliteitsdocumenten) van de QA-manager bij het opzetten of vernieuwen van het kwaliteitssysteem;<\/li>\n<li>Het invullen van de positie van de QA-manager op interim-basis;<\/li>\n<li>Het delen van ervaringen met de QA-manager;<\/li>\n<li>Audits uitvoeren op het systeem en het geven van feedback voor verbetering;<\/li>\n<li>Het co\u00f6rdineren van verbetermaatregelen.<\/li>\n<\/ul>\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][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; 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