{"id":14738,"date":"2024-07-04T16:01:29","date_gmt":"2024-07-04T14:01:29","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14738"},"modified":"2025-05-20T16:09:09","modified_gmt":"2025-05-20T14:09:09","slug":"certification-iso-9001","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/certification-iso-9001\/","title":{"rendered":"Qu&rsquo;est-ce qu&rsquo;on entend par Certification ISO 9001?"},"content":{"rendered":"<p><em>Nous avons r\u00e9alis\u00e9 une vid\u00e9o pour vous aider \u00e0 <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>comprendre ce qu&rsquo;est l&rsquo;ISO9001<\/strong><\/a>. Pour cela, nous avons interview\u00e9 Tania Schmit, notre responsable qualit\u00e9.<\/em><\/p>\n<p><iframe data-src=\"https:\/\/www.youtube.com\/embed\/gYw7d-7u8KY\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" data-mce-fragment=\"1\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/p>\n<p><!--more--><\/p>\n<p><em>Bonjour, je suis Vanessa Montanari, la g\u00e9rante de Pharmaspecific\u00a0; Bonjour Tania, \u00a0<\/em><\/p>\n<p>Bonjour Vanessa<\/p>\n<p>Aujourd\u2019hui, nous allons parler de l\u2019<strong>ISO9001.<\/strong><\/p>\n<h2><strong>Tania, C\u2019est quoi l\u2019ISO 9001\u00a0?<\/strong><\/h2>\n<p>C\u2019est un ensemble des directives organisationnelles \u00e0 usage international qui sont r\u00e9uni dans un document et qui sert \u00e0 impl\u00e9menter un syst\u00e8me de management de la qualit\u00e9. Ce document est appel\u00e9 couramment la <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>norme internationale ISO 9001<\/strong><\/a>.<\/p>\n<h2><strong>C\u2019est quoi un syst\u00e8me de management de la qualit\u00e9\u00a0?<\/strong><\/h2>\n<p>D\u2019abord, un syst\u00e8me de management de la qualit\u00e9 est amen\u00e9 \u00e0 repr\u00e9senter l\u2019ensemble de la structure organisationnelle d\u2019un organisme ou d\u2019une soci\u00e9t\u00e9.<\/p>\n<p>Plus pr\u00e9cis\u00e9ment, ce syst\u00e8me va montrer comment les activit\u00e9s ou les processus d\u2019un organisme vont interagir entre eux.<\/p>\n<p>Le but de cette organisation est de faciliter la compr\u00e9hension de la dynamique et les interactions de ces activit\u00e9s ou processus.<\/p>\n<h2><strong>\u00c0 quoi sert cette norme internationale ISO 9001\u00a0?<\/strong><\/h2>\n<p>Comme il a \u00e9t\u00e9 mentionn\u00e9 pr\u00e9c\u00e9demment, <strong>la norme ISO 9001<\/strong> va aider les entreprises \u00e0 cadrer leur organisation par le biais de la mise en place d\u2019<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite\/\">un syst\u00e8me de management de qualit\u00e9<\/a>.<\/p>\n<p>L\u2019impl\u00e9mentation de ce syst\u00e8me ainsi que <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>la certification ISO 9001<\/strong><\/a> ne sont pas obligatoires.<\/p>\n<p>Mais il est conseill\u00e9 \u00e0 tout organisme, la mise en place d\u2019un syst\u00e8me de management de qualit\u00e9 sans forc\u00e9ment suivre le chemin de la certification.<\/p>\n<h2><strong>Quels sont les principes de la norme ISO 9001\u00a0?<\/strong><\/h2>\n<p>Actuellement, l\u2019ISO 9001 version 2015 s\u2019appuie sur les principes suivants\u00a0:<\/p>\n<ul>\n<li>La Satisfaction du client<\/li>\n<li>Le leadership de la Direction<\/li>\n<li>L\u2019implication et la motivation du personnel de la soci\u00e9t\u00e9<\/li>\n<li>L\u2019approche processus des activit\u00e9s<\/li>\n<li>L\u2019am\u00e9lioration de la performance de la soci\u00e9t\u00e9<\/li>\n<li>La Prise de d\u00e9cision fond\u00e9e sur les preuves<\/li>\n<li>Le Management des relations avec les parties int\u00e9ress\u00e9es<\/li>\n<\/ul>\n<h2><strong>\u00a0C\u2019est quoi une certification ISO 9001\u00a0?<\/strong><\/h2>\n<p>La certification ISO 9001, c\u2019est simplement la reconnaissance que notre syst\u00e8me de management de qualit\u00e9 est en ad\u00e9quation aux exigences de la norme ISO 9001.<\/p>\n<p><a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>L\u2019attribution de la certification ISO 9001<\/strong><\/a> est r\u00e9alis\u00e9e par un organisme certificateur apr\u00e8s avoir effectu\u00e9 un audit du syst\u00e8me de management de la soci\u00e9t\u00e9 et ne pas avoir trouv\u00e9 des non-conformit\u00e9s qui pourraient affecter le syst\u00e8me.<\/p>\n<h2><strong>Pourquoi se faire certifier ISO 9001\u00a0?<\/strong><\/h2>\n<p>Vanessa, Les avantages de se faire certifier ISO 9001 sont nombreux, entres autres\u00a0:<\/p>\n<ul>\n<li>Une am\u00e9lioration de la satisfaction de nos clients<\/li>\n<li>Elle nous permet aussi l\u2019acc\u00e8s \u00e0 des nouveaux march\u00e9s<\/li>\n<li>Nous pouvons r\u00e9duire les co\u00fbts de non-qualit\u00e9 qui sont li\u00e9s aux \u00e9ventuels dysfonctionnements ou r\u00e9clamations<\/li>\n<li>Nous pouvons piloter notre organisme de fa\u00e7on plus efficace<\/li>\n<li>L\u2019image de la soci\u00e9t\u00e9 est impact\u00e9e favorablement<\/li>\n<li>Les ventes de la soci\u00e9t\u00e9 sont augment\u00e9es<\/li>\n<li>Une valorisation des salari\u00e9s qui travaillent pour un organisme qui est certifi\u00e9 ISO.<\/li>\n<\/ul>\n<h2><strong>Qui peut se certifier ISO 9001\u00a0?\u00a0<\/strong><\/h2>\n<p>Eh bien, peuvent se certifier ISO 9001, toute entreprise ou tout organisme, quelle que soit sa taille et son secteur d\u2019activit\u00e9.<\/p>\n<p><em>R\u00e9dig\u00e9 par Vanessa Montanari<\/em><\/p>\n<hr \/>\n<p>Vous avez besoin d&rsquo;une <strong>prestation en recherche clinique ? contactez PHARMASPECIFIC <\/strong>en vous rendant sur notre site en cliquant ici<strong> : <a href=\"https:\/\/pharmaspecific.com\/devis\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific.com\/devis\/<\/a><\/strong><\/p>\n<p><em>Si tu as des questions sur le m\u00e9tier d\u2019attach\u00e9 de recherche clinique ou sur une carri\u00e8re dans la recherche clinique, tu peux la mettre dans les commentaires ci-dessous. Nous te r\u00e9pondrons dans les plus brefs d\u00e9lais.\u00a0<\/em><\/p>\n<p><em>Si tu veux \u00eatre coach\u00e9, si tu veux une r\u00e9ponse personnalis\u00e9e \u00e0 tes questions ou \u00eatre en contact avec d\u2019autres professionnels de la recherche clinique, tu peux te rendre sur\u00a0<a href=\"https:\/\/pharmaspecific-training.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific-training.com\/<\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Nous avons r\u00e9alis\u00e9 une vid\u00e9o pour vous aider \u00e0 comprendre ce qu&rsquo;est l&rsquo;ISO9001. Pour cela, nous avons interview\u00e9 Tania Schmit, notre responsable qualit\u00e9.<\/p>","protected":false},"author":4,"featured_media":14740,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[450],"tags":[254,255,256],"class_list":{"0":"post-14738","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-actualites-de-la-recherche-clinique","8":"tag-certification","9":"tag-iso9001","10":"tag-management-de-qualite"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qu&#039;est-ce que la certification ISO9001?<\/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:\/\/blogdelarechercheclinique.com\/en\/certification-iso-9001\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qu&#039;est-ce qu&#039;on entend par Certification ISO 9001? 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