{"id":40725,"date":"2024-03-25T11:48:54","date_gmt":"2024-03-25T10:48:54","guid":{"rendered":"https:\/\/clariscience.com\/servizi-clariscience\/quality-management-systems\/auditing\/internal-audit"},"modified":"2026-04-23T17:09:50","modified_gmt":"2026-04-23T15:09:50","slug":"internal-audit","status":"publish","type":"servizi-clariscience","link":"https:\/\/clariscience.com\/en\/services\/quality-management-systems\/auditing\/internal-audit","title":{"rendered":"Internal audit"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"40725\" class=\"elementor elementor-40725 elementor-28161\" data-elementor-post-type=\"servizi-clariscience\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9d6147f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9d6147f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c19f767\" data-id=\"c19f767\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e83498a elementor-widget elementor-widget-text-editor\" data-id=\"e83498a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3><strong>Want to be sure your QMS is truly effective and compliant?<br><\/strong><\/h3><p><strong>Internal audits<\/strong> are the key tool to verify performance, anticipate potential issues, and improve business processes.<\/p><p>Clariscience supports Life Science companies with a comprehensive <strong>internal audit service, carried out by qualified, independent auditors with proven expertise in medical devices and IVD<\/strong>. Our goal is to assess the <strong>effectiveness, efficiency, and compliance of your Quality Management System (QMS) against applicable standards<\/strong> (ISO 13485, ISO 9001, MDR, IVDR), providing an objective and constructive perspective. <\/p><h3><strong>Why conduct an internal audit?<\/strong><\/h3><p>Internal audits are not just a regulatory requirement (ISO 13485 \/ ISO 9001)\u2014they are a <strong>strategic choice<\/strong> to maintain process control, prevent non-conformities, strengthen your quality culture, and prepare effectively for certification audits (system and product).<\/p><h3><strong>Why outsource internal audit?<\/strong><\/h3><p>Partnering with an external qualified auditor means gaining <strong>an objective, independent analysis based on real-world experience<\/strong> in the medical and IVD sectors.<br>Many companies choose to outsource because it allows them to:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe53daf elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"fe53daf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Ensure impartial evaluation of the QMS<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Gain an external perspective to prevent issues and highlight strengths<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Receive actionable improvement insights based on best practices<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Access specialized expertise that is hard to maintain internally<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Optimize time and resources, especially during critical phases like certification preparation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Train staff through direct interaction with experienced auditors<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bee6ce elementor-widget elementor-widget-text-editor\" data-id=\"4bee6ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Outsourcing your audit means <strong>choosing informed control<\/strong>\u2014a fresh perspective that <strong>anticipates risks and enhances what works<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-42ba39e elementor-widget elementor-widget-text-editor\" data-id=\"42ba39e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3><strong>Our service <\/strong><\/h3><ol><li><h4><strong>Shared planning<\/strong><\/h4>We define objectives, scope, and audit criteria together and prepare a tailored audit plan aligned with your business needs.<\/li><li><h4><strong>On-site assessment<\/strong><\/h4>Our auditor visits your site(s), reviews documentation, interviews staff and collects objective evidence.<\/li><li><h4><strong>Open communication<\/strong><\/h4>Throughout the audit, we share observations and suggestions with your team and management, ensuring a constructive dialogue focused on identifying issues and finding solutions. <\/li><li><h4><strong>Detailed report &amp; post-audit support<\/strong><\/h4>Receive a comprehensive report with any deviations and improvement proposals. Our auditor remains available for clarifications even after the visit. <\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e27f44 elementor-widget elementor-widget-text-editor\" data-id=\"9e27f44\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Why choose Clariscience<\/h3><p>Outsourcing your audit is <strong>not about delegating<\/strong>\u2014it\u2019s about <strong>strengthening your control<\/strong>.<br>Our service provides <strong>a clear, objective snapshot of your QMS<\/strong>, enriched by constructive feedback from expert auditors, <strong>tailored improvement insights<\/strong>, <strong>greater internal awareness<\/strong>, and <strong>ongoing support <\/strong>beyond the audit.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6269afc elementor-widget elementor-widget-text-editor\" data-id=\"6269afc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3><strong>Is your Quality Management System truly ready?<\/strong><\/h3><p>Request a personalized proposal now: <a href=\"mailto:info@clariscience.com\">info@clariscience.com<\/a><\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":29633,"parent":40719,"template":"","settori-servizi":[560,559,566],"class_list":["post-40725","servizi-clariscience","type-servizi-clariscience","status-publish","has-post-thumbnail","hentry","settori-servizi-md-en","settori-servizi-ivd-en","settori-servizi-xvi-en"],"acf":[],"yoast_head":"<title>Internal audit - 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