{"id":2470,"date":"2021-06-27T16:00:10","date_gmt":"2021-06-27T15:00:10","guid":{"rendered":"https:\/\/vosfoxmedical.com\/assurance-qualite\/"},"modified":"2025-04-30T15:45:56","modified_gmt":"2025-04-30T14:45:56","slug":"assurance-qualite","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/bienvenue-a-vosfox-medical\/assurance-qualite\/","title":{"rendered":"Assurance qualit\u00e9"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_112752620\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t<div class=\"section-bg-overlay absolute fill\"><\/div>\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\" style=\"max-width:1300px\" id=\"row-660639783\">\n\n\t<div id=\"col-874856039\" class=\"col medium-12 small-12 large-5\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-3422711093\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\">Assurance qualit\u00e9<\/h1>\n\t\t\n<style>\n#text-3422711093 {\n  font-size: 2.75rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_112752620 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: #5a0958;\n}\n#section_112752620 .section-bg-overlay {\n  background-color: rgba(90, 9, 88, 0.89);\n}\n#section_112752620 .section-bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/img-thunderstorm.jpg);\n}\n#section_112752620 .section-bg {\n  background-position: 90% 59%;\n}\n#section_112752620 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_112752620 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_112752620 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_112752620 {\n    min-height: 600px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n<div class=\"row align-bottom\" style=\"max-width:1300px\" id=\"row-1026662019\">\n\n\t<div id=\"col-23320473\" class=\"col medium-12 small-12 large-8 medium-col-first\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1924267082\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1924267082 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-1924267082 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/photo-logo-qa.jpg);\n}\n#banner-1924267082 .bg {\n  background-position: 60% 33%;\n}\n#banner-1924267082 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1924267082 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-1924267082 {\n    padding-top: 600px;\n  }\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-23320473 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-23320473 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-23320473 > .col-inner {\n    margin: -500px 0px 0px 0px;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<section class=\"section\" id=\"section_1432334778\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row row-small align-equal\"  id=\"row-1813029823\">\n\n\t<div id=\"col-771630550\" class=\"col sticky hide-for-small medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<ul class=\"sidebar-wrapper ul-reset\"><div id=\"text-6\">\t\t\t<div class=\"textwidget\"><h3 class=\"has-text-align-left\"><a href=\"#valeurs\">L&rsquo;assurance qualit\u00e9<\/a><\/h3>\n<h3 class=\"has-text-align-left\"><a href=\"#qualit\u00e9\">Controle de la qualit\u00e9<\/a><\/h3>\n<h3 class=\"has-text-align-left\"><a href=\"#service\">QA\/RA en tant que service<\/a><\/h3>\n<h3 id=\"h-T\u00e9l\u00e9charger certification\" class=\"has-text-align-left\"><a href=\"https:\/\/vosfoxmedical.com\/13485-vosfox-till-2-nov-2027\/\">T\u00e9l\u00e9charger certification<\/a><\/h3>\n<\/div>\n\t\t<\/div><\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-963854438\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<span class=\"scroll-to\" data-label=\"Scroll to: #assurance\" data-bullet=\"false\" data-link=\"#assurance\" data-title=\"assurance\"><a name=\"assurance\"><\/a><\/span>\n<p class=\"lead\">L&rsquo;assurance qualit\u00e9 est l&rsquo;une des valeurs fondamentales de Vosfox Medical.<br \/>Nous disposons d&rsquo;une certification <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2024\/12\/13485-Vosfox-till-2-Nov-2027.pdf\">ISO13485<\/a><\/strong><\/span>:2016 avec le num\u00e9ro 10659127 et le champ d&rsquo;application suivant :<\/p>\n<p class=\"lead\"><strong>Fabrication \u00e0 fa\u00e7on et emballage sous barri\u00e8re st\u00e9rile de dispositifs et de composants m\u00e9dicaux implantables et non implantables \u00e0 base de plastique imprim\u00e9s en 3D.<\/strong><\/p>\n<p class=\"lead\">Nous travaillons \u00e9galement \u00e0 l&rsquo;obtention de la certification cGMP pour servir les clients qui l&rsquo;exigent.<\/p>\n<p>Les exigences en mati\u00e8re d&rsquo;assurance qualit\u00e9 pour la production de dispositifs m\u00e9dicaux sont strictes, comme il se doit.<br \/>Notre syst\u00e8me d&rsquo;assurance qualit\u00e9 est flexible et bas\u00e9 sur le risque, car nos processus sont plus stricts pour les produits \u00e0 haut risque, mais nous ne voulons pas en faire trop pour les processus \u00e0 faible risque.<br \/>Ce principe permet de r\u00e9duire les co\u00fbts.<br \/>Nous disposons d&rsquo;un syst\u00e8me de gestion de la qualit\u00e9 flexible qui nous permet d&rsquo;ajouter rapidement de nouveaux produits, de nouveaux processus et de nouveaux clients.<br \/>L&rsquo;accord d&rsquo;assurance qualit\u00e9 (QAA) garantit qu&rsquo;il n&rsquo;y a pas de malentendu entre Vosfox Medical et nos clients sur les questions de qualit\u00e9.<\/p>\n<span class=\"scroll-to\" data-label=\"Scroll to: #qualit\u00e9\" data-bullet=\"false\" data-link=\"#qualit\u00e9\" data-title=\"qualit\u00e9\"><a name=\"qualit\u00e9\"><\/a><\/span>\n<h2>Contr\u00f4le de la qualit\u00e9<\/h2>\n<p>  Nous pouvons effectuer des tests de contr\u00f4le de la qualit\u00e9 pour nous assurer que le produit ou le mat\u00e9riau r\u00e9pond aux exigences convenues.<br \/>\nSi nous ne pouvons pas le faire nous-m\u00eames, nous pouvons le confier \u00e0 des laboratoires qualifi\u00e9s.   <\/p>\n<h2>Audits<\/h2>\n<p>  Vosfox Medical dispose d&rsquo;un plan d&rsquo;audit interne pour v\u00e9rifier ses propres processus.<br \/>\nLe syst\u00e8me de gestion de la qualit\u00e9 est audit\u00e9 chaque ann\u00e9e par notre organisme notifi\u00e9, BSI.<br \/>\nLes audits des fournisseurs sont r\u00e9alis\u00e9s en accord avec nos clients.<br \/>\nNous pouvons proposer d&rsquo;auditer les fournisseurs et les sous-traitants, mais les clients peuvent \u00e9galement garder ce contr\u00f4le pour leur produit.<br \/>\nLes clients sont invit\u00e9s \u00e0 effectuer un audit sur place.<br \/>\nEn fonction de la fr\u00e9quence des audits et de la taille de votre entreprise, nous pouvons \u00eatre amen\u00e9s \u00e0 facturer un audit.       <\/p>\n<h2>Validation<\/h2>\n<p>  Tous nos processus sont valid\u00e9s avant que la production commerciale ne soit possible.  <strong>Validation du processus.<\/strong>  Vosfox Medical valide tous les processus de production.<br \/>\nNous organisons la validation de mani\u00e8re \u00e0 minimiser le temps et les \u00e9chantillons.   <strong>Validation de la st\u00e9rilisation.<\/strong>  Si votre produit doit \u00eatre st\u00e9rilis\u00e9, nous pouvons vous proposer un service de soutien \u00e0 la validation de la st\u00e9rilisation.<br \/>\nNous pouvons r\u00e9diger les protocoles et\/ou les rapports et organiser les activit\u00e9s de st\u00e9rilisation et de charge biologique avec des entreprises de st\u00e9rilisation et des laboratoires de microbiologie certifi\u00e9s.   <strong>Validation de l&#8217;emballage.<\/strong>  Si votre emballage sert de barri\u00e8re st\u00e9rile, l&rsquo;int\u00e9grit\u00e9 du syst\u00e8me d&#8217;emballage doit \u00eatre test\u00e9e.  <strong>Tests de transport.<\/strong>  Votre dispositif m\u00e9dical doit arriver chez l&rsquo;utilisateur dans le m\u00eame \u00e9tat que lorsque vous l&rsquo;avez autoris\u00e9 \u00e0 \u00eatre transport\u00e9.<br \/>\nC&rsquo;est pourquoi des tests de transport sont n\u00e9cessaires.   <strong>Validation de la m\u00e9thode d&rsquo;essai.  <\/strong>Tous les essais CQ effectu\u00e9s doivent \u00eatre valid\u00e9s.<br \/>\nIl s&rsquo;agit d&rsquo;essais r\u00e9alis\u00e9s \u00e0 l&rsquo;aide d&rsquo;\u00e9quipements d&rsquo;analyse ou d&rsquo;essai, mais aussi d&rsquo;inspections visuelles.<br \/>\nUne \u00e9tude GR&amp;R (Gauge Repeatability Reproducibility) en fait partie.<\/p>\n<span class=\"scroll-to\" data-label=\"Scroll to: #service\" data-bullet=\"false\" data-link=\"#service\" data-title=\"service\"><a name=\"service\"><\/a><\/span>\n<h2><strong>QA\/RA en tant que service<\/strong><\/h2>\n<p>  Vosfox Medical peut fournir un service d&rsquo;assurance qualit\u00e9 \u00e0 ses clients.<br \/>\nSi notre exp\u00e9rience nous permet d&rsquo;apporter une valeur ajout\u00e9e \u00e0 votre syst\u00e8me de management de la qualit\u00e9 ou \u00e0 votre dossier technique, nous pouvons vous proposer un service de conseil.<br \/>\nIl peut s&rsquo;agir par exemple de la gestion des risques, d&rsquo;une recherche bibliographique pour les essais de biocompatibilit\u00e9 ou d&rsquo;une r\u00e9vision de certaines parties du dossier technique.<\/p>\n\t<div id=\"text-524695971\" class=\"text show-for-small\">\n\t\t\n<h3><a href=\"https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2022\/09\/img-iso13485-certificate.jpg\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-424\" src=\"https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/11\/download-certificate-18.svg\" alt=\"\" width=\"25\" height=\"25\"> <span style=\"text-decoration: underline;\">T\u00e9l\u00e9charger le certificat<\/span><\/a><\/h3>\n\t\t\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1432334778 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1432334778 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1432334778 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_1432334778 {\n    padding-top: 70px;\n    padding-bottom: 70px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":2553,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-2470","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.2 (Yoast SEO v27.4) - 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