{"id":4624,"date":"2026-05-13T11:05:15","date_gmt":"2026-05-13T09:05:15","guid":{"rendered":"https:\/\/azurea.ch\/?p=4624"},"modified":"2026-05-13T11:09:27","modified_gmt":"2026-05-13T09:09:27","slug":"quality-management-system-smq-a-pillar-of-compliance-in-medtech","status":"publish","type":"post","link":"https:\/\/azurea.ch\/en\/systeme-de-management-de-la-qualite-smq-un-pilier-de-la-conformite-en-medtech\/","title":{"rendered":"Quality management systems (QMS): a pillar of compliance in medtech"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4624\" class=\"elementor elementor-4624\" data-elementor-post-type=\"post\">\n\t\t\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-dbd44e1 e-flex e-con-boxed e-con e-parent\" data-id=\"dbd44e1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21d6de2 elementor-widget elementor-widget-heading\" data-id=\"21d6de2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">La tra\u00e7abilit\u00e9 comme fil conducteur<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-36ae281 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"36ae281\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"0\" data-end=\"257\">La tra\u00e7abilit\u00e9 est au c\u0153ur de la ma\u00eetrise du produit et chaque composant doit pouvoir \u00eatre reli\u00e9 \u00e0 son historique mati\u00e8re, \u00e0 son lot, \u00e0 ses op\u00e9rations de fabrication ainsi qu\u2019aux contr\u00f4les associ\u00e9s, afin de garantir une identification fiable \u00e0 chaque \u00e9tape.<\/p><p data-start=\"259\" data-end=\"612\" data-is-last-node=\"\" data-is-only-node=\"\">D\u00e8s la conception des processus, cette exigence permet de retrouver, prouver et expliquer avec pr\u00e9cision l\u2019origine et le parcours de chaque dispositif. Le cadre <strong>UDI (<em>Unique Device Identification<\/em>)<\/strong> renforce ce niveau d\u2019exigence et standardise l\u2019identification des dispositifs m\u00e9dicaux afin de faciliter leur suivi, y compris apr\u00e8s leur mise sur le march\u00e9.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-3d9831c e-con-full e-flex e-con e-parent\" data-id=\"3d9831c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-e63c04d e-con-full e-flex e-con e-child\" data-id=\"e63c04d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d50b48c elementor-widget elementor-widget-heading\" data-id=\"d50b48c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Qualification et validation des proc\u00e9d\u00e9s<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-92f0bf4 elementor-widget elementor-widget-text-editor\" data-id=\"92f0bf4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p class=\"my-2 [&amp;+p]:mt-4 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\">La qualification consiste \u00e0 d\u00e9montrer, de mani\u00e8re document\u00e9e, qu\u2019un proc\u00e9d\u00e9, un \u00e9quipement ou un outil fonctionne correctement dans des conditions d\u00e9finies. Elle s\u2019articule g\u00e9n\u00e9ralement en trois \u00e9tapes compl\u00e9mentaires :<\/p>\n\n<ul>\n \t<li class=\"my-2 [&amp;+p]:mt-4 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\"><strong>La qualification d\u2019installation (QI)<\/strong>, qui v\u00e9rifie que les \u00e9quipements sont correctement install\u00e9s<\/li>\n \t<li class=\"my-2 [&amp;+p]:mt-4 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\"><strong>La qualification op\u00e9rationnelle (QO)<\/strong>, qui valide leur bon fonctionnement<\/li>\n \t<li class=\"my-2 [&amp;+p]:mt-4 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\"><strong>La qualification de performance (QP)<\/strong>, qui confirme leur capacit\u00e9 \u00e0 produire de mani\u00e8re constante un r\u00e9sultat conforme. \u00c0 travers cette approche, chaque \u00e9tape du processus devient mesurable, ma\u00eetris\u00e9e et reproductible.<\/li>\n<\/ul>\n<p data-start=\"0\" data-end=\"409\"><br>La validation intervient lorsque les \u00e9quipes ne peuvent pas contr\u00f4ler directement le produit, notamment lorsque les tests sont destructifs ou susceptibles d\u2019alt\u00e9rer la pi\u00e8ce. Dans ces situations, elles s\u2019appuient sur des protocoles rigoureux, des sc\u00e9narios de test document\u00e9s et une analyse approfondie des r\u00e9sultats pour garantir la conformit\u00e9. Elles valident alors le proc\u00e9d\u00e9 lui-m\u00eame plut\u00f4t que le produit.<\/p>\n<p data-start=\"411\" data-end=\"698\" data-is-last-node=\"\" data-is-only-node=\"\">L\u2019ensemble s\u2019int\u00e8gre dans un syst\u00e8me qualit\u00e9 structur\u00e9, o\u00f9 les \u00e9quipes d\u00e9finissent, suivent et rendent chaque processus auditable. Cette exigence s\u2019\u00e9tend \u00e9galement aux moyens de contr\u00f4le et aux partenaires externes, qu\u2019Azurea qualifie et \u00e9value selon des standards align\u00e9s sur les siens.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-0831836 e-con-full e-flex e-con e-child\" data-id=\"0831836\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c2b22d7 elementor-widget elementor-widget-image\" data-id=\"c2b22d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"532\" src=\"https:\/\/azurea.ch\/wp-content\/uploads\/2026\/05\/DSC_0004.jpg\" class=\"attachment-full size-full wp-image-4848\" alt=\"\" srcset=\"https:\/\/azurea.ch\/wp-content\/uploads\/2026\/05\/DSC_0004.jpg 800w, https:\/\/azurea.ch\/wp-content\/uploads\/2026\/05\/DSC_0004-300x200.jpg 300w, https:\/\/azurea.ch\/wp-content\/uploads\/2026\/05\/DSC_0004-768x511.jpg 768w, https:\/\/azurea.ch\/wp-content\/uploads\/2026\/05\/DSC_0004-18x12.jpg 18w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-08ba7f5 e-flex e-con-boxed e-con e-parent\" data-id=\"08ba7f5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8fadd7c elementor-widget elementor-widget-heading\" data-id=\"8fadd7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Le r\u00f4le cl\u00e9 du dossier technique<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc3c3f8 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"cc3c3f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"0\" data-end=\"268\">Le dossier technique constitue un \u00e9l\u00e9ment central qui regroupe l\u2019ensemble des protocoles, qualifications, tests de r\u00e9p\u00e9tabilit\u00e9 ainsi que les documents de fabrication. Il permet de d\u00e9montrer \u00e0 la fois la conformit\u00e9 du produit et la ma\u00eetrise des proc\u00e9d\u00e9s de production.<\/p><p data-start=\"270\" data-end=\"726\">Azurea remet ce dossier au client afin de prouver que toutes les exigences ont \u00e9t\u00e9 respect\u00e9es. Il garantit que les produits livr\u00e9s sont conformes, tra\u00e7ables et r\u00e9alis\u00e9s selon des m\u00e9thodes pr\u00e9alablement valid\u00e9es. Azurea int\u00e8gre \u00e9galement l\u2019analyse de risques <strong>(AMDEC)<\/strong> au dossier. Cette analyse identifie les risques potentiels, d\u00e9finit les moyens de pr\u00e9vention et pr\u00e9cise les actions correctives \u00e0 mettre en \u0153uvre afin d\u2019assurer un haut niveau de conformit\u00e9.<\/p><p data-start=\"728\" data-end=\"1015\" data-is-last-node=\"\" data-is-only-node=\"\">Dans le cadre de l\u2019obtention du <strong>marquage CE<\/strong>, le dossier technique contribue \u00e0 la constitution du dossier d\u2019affaires r\u00e9glementaire. Le client reste responsable de la constitution du dossier complet, en s\u2019appuyant sur les \u00e9l\u00e9ments techniques et les preuves de conformit\u00e9 qu\u2019Azurea fournit.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-e4d9be5 e-con-full e-flex e-con e-parent\" data-id=\"e4d9be5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-519f9ea elementor-widget elementor-widget-heading\" data-id=\"519f9ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">La culture qualit\u00e9 d'Azurea<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-976385a elementor-widget elementor-widget-text-editor\" data-id=\"976385a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"0\" data-end=\"463\">Le syst\u00e8me de management de la qualit\u00e9 prend pleinement vie gr\u00e2ce \u00e0 l\u2019implication des collaborateurs, chacun \u00e9tant conscient de son r\u00f4le dans la conformit\u00e9 globale. Dans le medtech, o\u00f9 l\u2019exigence est constante, les \u00e9quipes doivent pouvoir d\u00e9montrer la qualit\u00e9 \u00e0 chaque \u00e9tape. Elles s\u2019appuient pour cela sur une formation\u00a0 interne, adapt\u00e9e \u00e0 chaque fonction, afin d\u2019ancrer durablement les bonnes pratiques dans les processus et les m\u00e9tiers.<\/p><p data-start=\"465\" data-end=\"1076\" data-is-last-node=\"\" data-is-only-node=\"\">La responsabilisation constitue un autre pilier essentiel. Chaque responsable pilote son processus et veille au respect des exigences du syst\u00e8me qualit\u00e9 dans son p\u00e9rim\u00e8tre. Cette organisation favorise l\u2019engagement individuel et collectif en int\u00e9grant la qualit\u00e9 comme une responsabilit\u00e9 partag\u00e9e. En compl\u00e9ment, les \u00e9quipes r\u00e9alisent r\u00e9guli\u00e8rement des audits internes afin d\u2019assurer un suivi rigoureux des pratiques, d\u2019identifier les axes d\u2019am\u00e9lioration et de garantir la conformit\u00e9 continue du syst\u00e8me. Ainsi, l\u2019ensemble de l\u2019organisation porte la qualit\u00e9 dans une dynamique globale, au-del\u00e0 d\u2019un seul service.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-1c946a4 e-flex e-con-boxed e-con e-parent\" data-id=\"1c946a4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-66d037a e-con-full e-flex e-con e-child\" data-id=\"66d037a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f913d25 elementor-widget elementor-widget-heading\" data-id=\"f913d25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Verticalisation des op\u00e9rations et qualification des prestataires externes<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab37731 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"ab37731\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"0\" data-end=\"482\">La verticalisation permet \u00e0 l\u2019entreprise de centraliser les diff\u00e9rentes \u00e9tapes de production et de contr\u00f4le au sein d\u2019un m\u00eame syst\u00e8me qualit\u00e9. Cette approche renforce la ma\u00eetrise des op\u00e9rations, am\u00e9liore la tra\u00e7abilit\u00e9 et garantit une meilleure coh\u00e9rence dans l\u2019application des proc\u00e9dures et des standards de qualit\u00e9. En conservant les activit\u00e9s cl\u00e9s en interne, l\u2019entreprise limite \u00e9galement les risques li\u00e9s \u00e0 la dispersion des processus et facilite le suivi des points critiques.<\/p><p data-start=\"484\" data-end=\"1080\" data-is-last-node=\"\" data-is-only-node=\"\">Lorsque certaines op\u00e9rations doivent \u00eatre externalis\u00e9es, des proc\u00e9dures strictes de qualification et de validation des prestataires sont mises en place afin d\u2019assurer un niveau de qualit\u00e9 \u00e9quivalent \u00e0 celui appliqu\u00e9 en interne. Cette validation repose notamment sur des audits permettant d\u2019\u00e9valuer le syst\u00e8me qualit\u00e9 du fournisseur, ses m\u00e9thodes de fonctionnement, sa gestion des risques ainsi que la r\u00e9p\u00e9tabilit\u00e9 et la conformit\u00e9 des services fournis. Ces contr\u00f4les garantissent que les partenaires externes respectent les m\u00eames exigences de qualit\u00e9 et de fiabilit\u00e9 que l\u2019organisation elle-m\u00eame.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c65fc5 elementor-widget elementor-widget-heading\" data-id=\"6c65fc5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Les normes des exigences sectorielles<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe25049 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"fe25049\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p class=\"my-2 [&amp;+p]:mt-4 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\">Les normes appliqu\u00e9es au sein de l\u2019entreprise s\u2019appuient principalement sur les r\u00e9f\u00e9rentiels<strong> ISO 13485<\/strong> et <strong>ISO 14001<\/strong>, chacun r\u00e9pondant \u00e0 des exigences sp\u00e9cifiques selon son domaine d\u2019application.<\/p><ul><li>La norme ISO 14001 encadre le management environnemental et vise \u00e0 int\u00e9grer la ma\u00eetrise des impacts environnementaux dans l\u2019ensemble des activit\u00e9s de l\u2019entreprise, quel que soit son secteur. Elle favorise une approche structur\u00e9e fond\u00e9e sur l\u2019am\u00e9lioration continue, la conformit\u00e9 r\u00e9glementaire et la responsabilit\u00e9 environnementale.<\/li><li>De son c\u00f4t\u00e9, la norme ISO 13485 est d\u00e9di\u00e9e au secteur des dispositifs m\u00e9dicaux et impose des exigences particuli\u00e8rement rigoureuses. Elle encadre notamment la tra\u00e7abilit\u00e9, la gestion des risques, la validation des proc\u00e9d\u00e9s et la conformit\u00e9 aux exigences r\u00e9glementaires. Son objectif est d\u2019assurer la s\u00e9curit\u00e9, la fiabilit\u00e9 et la qualit\u00e9 des dispositifs m\u00e9dicaux tout au long de leur cycle de vie. Elle conduit ainsi \u00e0 la mise en place de processus document\u00e9s, ma\u00eetris\u00e9s et reproductibles, garantissant un niveau \u00e9lev\u00e9 de s\u00e9curit\u00e9 pour les patients comme pour les utilisateurs.<\/li><\/ul><p>\u00a0<\/p><p><span style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji';\">Bien que leurs p\u00e9rim\u00e8tres diff\u00e8rent, ces deux normes s\u2019inscrivent dans une m\u00eame logique de pilotage des processus, de ma\u00eetrise des risques et d\u2019am\u00e9lioration continue, contribuant \u00e0 renforcer la performance globale et la conformit\u00e9 de l\u2019entreprise.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bcb404c elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"bcb404c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-56ce2cf e-flex e-con-boxed e-con e-parent\" data-id=\"56ce2cf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-017e984 e-con-full e-flex e-con e-child\" data-id=\"017e984\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c878b31 elementor-widget elementor-widget-text-editor\" data-id=\"c878b31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h5>Chez Azurea, le syst\u00e8me de management de la qualit\u00e9 structure les op\u00e9rations, garantit la conformit\u00e9 et renforce durablement la confiance dans chaque dispositif.<\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7aa053b elementor-align-left elementor-widget elementor-widget-button\" data-id=\"7aa053b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/azurea.ch\/sites\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Nous contacter<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-35a9711 e-con-full e-flex e-con e-child\" data-id=\"35a9711\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9fbefa9 elementor-widget__width-initial elementor-widget-mobile_extra__width-initial elementor-widget elementor-widget-image\" data-id=\"9fbefa9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"100\" height=\"100\" src=\"https:\/\/azurea.ch\/wp-content\/uploads\/2023\/09\/favicon.jpg\" class=\"attachment-full size-full wp-image-21\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-acba008 elementor-widget__width-initial elementor-widget-mobile_extra__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"acba008\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Azurea :<br \/>l\u00e0 o\u00f9 la <strong>pr\u00e9cision<\/strong> devient <strong>performance<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>La tra\u00e7abilit\u00e9 comme fil conducteur La tra\u00e7abilit\u00e9 est au c\u0153ur de la ma\u00eetrise du produit et chaque composant doit pouvoir \u00eatre reli\u00e9 \u00e0 son historique mati\u00e8re, \u00e0 son lot, \u00e0 ses op\u00e9rations de fabrication ainsi qu\u2019aux contr\u00f4les associ\u00e9s, afin de garantir une identification fiable \u00e0 chaque \u00e9tape. D\u00e8s la conception des processus, cette exigence permet [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4848,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4624","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classe"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Syst\u00e8me de management de la qualit\u00e9 en medtech | Azurea<\/title>\n<meta name=\"description\" content=\"Syst\u00e8me de management de la qualit\u00e9 medtech : structuration des processus, conformit\u00e9 et tra\u00e7abilit\u00e9 des op\u00e9rations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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