{"id":50097,"date":"2024-06-25T17:15:45","date_gmt":"2024-06-25T15:15:45","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/lo-svolgimento-dellaudit-interno"},"modified":"2024-11-11T16:26:15","modified_gmt":"2024-11-11T15:26:15","slug":"internal-audits","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/quality\/internal-audits","title":{"rendered":"Conducting internal audits"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"50097\" class=\"elementor elementor-50097 elementor-46150\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8900f13 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8900f13\" 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-be3d8bb\" data-id=\"be3d8bb\" 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-ccd99c1 elementor-widget elementor-widget-text-editor\" data-id=\"ccd99c1\" 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>The first-party audit, or <strong>internal audit<\/strong>, is a <strong>fundamental tool<\/strong> that companies can (and must) <strong>adopt to evaluate whether their Quality Management System (QMS) is effective and efficient<\/strong>, compliant with applicable requirements, <strong>effectively implemented, operated, and maintained<\/strong>, and whether its constituent elements (Quality Manual, procedures, records, etc.) are <strong>known and correctly used<\/strong> by all personnel.<\/p><p>The ISO 13485 standard establishes that the organization must <strong>conduct internal audits at planned intervals:<\/strong> it is good practice to <strong>verify all business processes<\/strong> at least once a year, taking into account <strong>the status and importance of the processes and areas being audited<\/strong>, as well as the <strong>results of previous internal audits.<\/strong><\/p><p>The entire internal audit process can be conducted through interviews with personnel and reviewing the documentary evidence made available, and it is divided into:<\/p><ol><li>Opening meeting<\/li><li>Field audit conduct and evidence collection<\/li><li>Drafting of the audit report<\/li><li>Closing meeting<\/li><\/ol><p>For the operational management of internal audits, the <strong>ISO 19011<\/strong> guidelines for auditing management systems can be considered.<\/p><h2>Preparation for the Audit<\/h2><p>The audit team leader is responsible for drafting an <strong>audit plan<\/strong>, which should be delivered to the process owners a few days before the audit. This plan should include at least the<strong> purpose, scope, and criteria <\/strong>of the audit, <strong>dates, locations, and times<\/strong> planned for the assessment of each process, as well as the <strong>definition of roles and responsibilities<\/strong> of the audit team members.<\/p><p>The audit team may also prepare <strong>checklists<\/strong> to be used as support for evidence collection.<\/p><h2>Opening Meeting<\/h2><p>The audit team holds an<strong> initial meeting<\/strong> to:<\/p><ul><li>Confirm the audit plan<\/li><li>Provide a brief summary of how the audit activities will be carried out<\/li><li>Confirm communication channels<\/li><li>Introduce the audit team and their respective roles<\/li><li>Address questions and resolve uncertainties of those being audited<\/li><\/ul><p>The opening meeting should be conducted in the presence of management (or a representative) and the process owners being audited.<\/p><h2>Field Conduct and Evidence Collection<\/h2><p>During the audit, auditors must <strong>periodically communicate the progress of the audit<\/strong> and any issues identified, <strong>immediately reporting all objective evidence that poses an immediate and significant risk.<\/strong> All information collected must be <strong>verified, and only verifiable information can be considered audit evidence<\/strong> and therefore recorded.<\/p><p>Evidence can be collected through appropriate <strong>sampling<\/strong> and via:<\/p><ul><li>Direct observation of activities<\/li><li>Interviews with personnel<\/li><li>Examination of the documentation in use related to the audit aspects and evaluation of the level of compliance with requirements<\/li><\/ul><h2>Drafting the Audit Report<\/h2><p>At the end of the audit activities, the audit team meets to document what was found and transcribe the results in the<strong> audit report<\/strong> [The Audit Report: An Effective and Compliant Structure]. The audit report should at least include:<\/p><ul><li>Objectives, scope, and criteria of the audit<\/li><li>Dates and sites where the audit was conducted<\/li><li>Audit team<\/li><li>Reference to the audit plan and any checklists used<\/li><li>Personnel interviewed and their roles within the organization<\/li><li>Collected evidence<\/li><li>Audit findings, obtained through comparison between collected evidence and audit criteria, which can be classified as observations, minor non-conformities, and major non-conformities<\/li><li>Conclusions<\/li><\/ul><h2>Closing Meeting<\/h2><p>Once the report is drafted, the audit team conducts a <strong>closing meeting<\/strong> to <strong>present the findings and conclusions of the audit<\/strong>, aiming to resolve any doubts and <strong>agree<\/strong>\u2014if non-conformities were identified\u2014on the<strong> timeframe for presenting the improvement plan.<\/strong><\/p><p>The same functions involved in the opening meeting should participate in the closing meeting.<\/p><h2>Follow-Up Activities<\/h2><p>The <strong>management of non-conformities<\/strong> resulting from the audit should be entrusted to the <strong>process owners in question<\/strong>, to identify the most suitable<strong> improvement actions<\/strong> to <strong>address the identified deviations.<\/strong><\/p><p>The completion and effectiveness of the improvement actions should be verified in the subsequent audit, unless <strong>particularly critical findings<\/strong> require an <strong>early verification.<\/strong><\/p><h2>Auditor Requirements<\/h2><p>The organization must <strong>define the qualifications<\/strong> required of auditors for conducting internal audits.<\/p><p>The selection of auditors and the conduct of internal audits must also<strong> ensure the objectivity and impartiality<\/strong> of the audit process; in particular, members of the audit team should be chosen considering the<strong> concept of independence<\/strong> from direct responsibility for the activities being audited: an auditor should never audit a process managed under their direct responsibility.<\/p><h2>Recording of Activities<\/h2><p>The organization must establish adequate <strong>procedures<\/strong> for managing internal audits.<\/p><p>All <strong>records<\/strong> of internal audits (audit plan and report, any checklists, auditor qualifications and certifications, etc.) <strong>must be maintained in a controlled format and retained for a predetermined period.<\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The ISO 13485 standard establishes that the organization must conduct internal audits at planned intervals: it is good practice to verify all business processes at least once a year, taking into account the status and importance of the processes and areas being audited, as well as the results of previous internal audits.<\/p>\n","protected":false},"author":328,"featured_media":50104,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[589,533],"tags":[575],"class_list":["post-50097","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-audit-interno-en","category-quality","tag-magazine-en"],"acf":[],"yoast_head":"<title>Conducting internal audits | Clariscience Magazine<\/title>\n<meta name=\"description\" content=\"The internal audit is a fundamental tool that companies can use to evaluate their Quality Management System.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clariscience.com\/en\/blog\/quality\/internal-audits\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Conducting internal audits | Clariscience Magazine\" \/>\n<meta property=\"og:description\" content=\"The internal audit is a fundamental tool that companies can use to evaluate their Quality Management System.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/clariscience.com\/en\/blog\/quality\/internal-audits\" \/>\n<meta property=\"og:site_name\" content=\"Clariscience\" \/>\n<meta property=\"article:published_time\" content=\"2024-06-25T15:15:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-11T15:26:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/06\/214_R_EN.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Veronica Grigio\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Veronica Grigio\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/quality\\\/internal-audits#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/quality\\\/internal-audits\"},\"author\":{\"name\":\"Veronica Grigio\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/person\\\/d7f4560946649b7824b7b8303d13b5e2\"},\"headline\":\"Conducting internal audits\",\"datePublished\":\"2024-06-25T15:15:45+00:00\",\"dateModified\":\"2024-11-11T15:26:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/quality\\\/internal-audits\"},\"wordCount\":727,\"publisher\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/quality\\\/internal-audits#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2024\\\/06\\\/214_Q_EN.jpg\",\"keywords\":[\"magazine\"],\"articleSection\":[\"25. 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