{"id":6868,"date":"2022-01-28T18:51:23","date_gmt":"2022-01-28T18:51:23","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=6868"},"modified":"2024-01-11T16:28:10","modified_gmt":"2024-01-11T16:28:10","slug":"planning-iso-13485-audit","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/planning-iso-13485-audit\/","title":{"rendered":"How to Prepare for and Conduct an ISO 13485 Internal QMS Audit"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6868\" class=\"elementor elementor-6868\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\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-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&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-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2022\/01\/28\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 28, 2022\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">How to Prepare for and Conduct an ISO 13485 Internal QMS Audit<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1709\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-scaled.jpeg\" class=\"attachment-full size-full wp-image-2615\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-300x200.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-1024x684.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-768x513.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-1536x1025.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/Virtual_Audit_OSAM-2048x1367.jpeg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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 class=\"elementor-element elementor-element-5dbeb456 elementor-widget elementor-widget-text-editor\" data-id=\"5dbeb456\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Covered in this guide: <\/strong>\u00a0<\/p><p><a href=\"#real-purpose\"><u>Real Purpose of the Medical Device QMS Audit<\/u><\/a><br \/><a href=\"#basic-types\"><u>Basic Types of ISO 13485 Audits\u00a0<\/u><\/a><br \/><a href=\"#audit-schedule\"><u>Developing Your Overall ISO 13485 Audit Schedule<\/u><\/a><br \/><a href=\"#qms-audit\"><u>Preparing for Your ISO 13485:2016 QMS Audit<\/u><\/a><br \/><a href=\"#documentation-review\"><u>Conducting a QMS Documentation Review<\/u><\/a><br \/><a href=\"#lead-auditor\"><u>Role of the ISO 13485 Lead Auditor<\/u><\/a><br \/><a href=\"#audit-plan\"><u>Creating the QMS Audit Plan<\/u><\/a><br \/><a href=\"#smoothly\"><u>Ensuring Day 1 of Your Audit Goes Smoothly<\/u><\/a><br \/><a href=\"#audit-duration\"><u>Average ISO 13485:2016 Audit Duration<\/u><\/a><br \/><a href=\"#rabbit-holes\"><u>Conducting the Audit and Avoiding Rabbit Holes<\/u><\/a><br \/><a href=\"#interview-tips\"><u>Audit Interviewing Tips<\/u><\/a><br \/><a href=\"#observations\"><u>Recording and Discussing Your Observations<\/u><\/a><br \/><a href=\"#closing-meeting\"><u>Conducting the Closing Meeting<\/u><\/a><br \/><a href=\"#now-what\"><u>You Successfully Finished Your Audit. Now What?<\/u><\/a><br \/><a href=\"#final-report\"><u>How Much Detail Goes into the Final Audit Report?<\/u><\/a><br \/><a href=\"#follow-up\"><u>ISO 13485 Internal or Supplier Audit Follow-Up Activities<\/u><\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_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<p><strong><em>Congratulations!\u00a0<\/em><\/strong>You have been chosen (or perhaps conscripted) to conduct or participate in an ISO 13485 internal quality management system (QMS) audit. For many, the prospect of coordinating and conducting an audit can be overwhelming. However, believe us when we say the fear subsides with each hour of planning you do. In this white paper we will talk about how you can lay the foundation to ensure that your ISO 13485 audit progresses smoothly, yielding input that\u2019s useful to your company\u2019s management review as well as its corrective and preventive action (CAPA) processes.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6532f0f elementor-widget elementor-widget-menu-anchor\" data-id=\"6532f0f\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\nbody.elementor-page .elementor-widget-menu-anchor{margin-bottom:0}<\/style>\t\t<div id=\"real-purpose\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Real Purpose of the Medical Device QMS Audit<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_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<p>Even though it seems obvious, it\u2019s worth repeating that the purpose of conducting an audit is to determine whether the QMS conforms to specified requirements and is effective in enabling your organization to meet quality objectives. In other words, you are trying to assess whether the organization\u2019s system says what it needs to say, that you\u2019re doing what you say you\u2019ll do, and that what you\u2019re doing is working to produce the outcomes you need. A QMS audit is NOT intended to evaluate the quality of products, nor does it focus on the performance of people. The emphasis is on the QMS processes and the effectiveness of the entire system in meeting defined requirements and objectives.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db0b42e elementor-widget elementor-widget-menu-anchor\" data-id=\"db0b42e\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"basic-types\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Basic Types of ISO 13485 Audits <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_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<p><strong>Audits are planned, systematic processes carried out according to prepared working documents\u00a0and audit plans.<\/strong><\/p><p>ISO 13485 talks about two main components of internal audits (section 8.2.4):<\/p><ul><li>Confirming that the organization&#8217;s QMS documentation conforms to the standard and any applicable regulatory requirements commonly called a\u00a0\u201c<em>documentation audit.\u201d<\/em><\/li><li>Confirming that the organization has implemented and is maintaining the QMS documentation commonly called an\u00a0\u201c<em>on-site audit.\u201d<\/em><\/li><\/ul><p>While documentation and on-site audits may seem like two entirely different animals, they are not. A thorough QMS audit includes both components. The difference between the two usually is in the approach and depth to which each of these audit components is conducted. The focus of the documentation audit centers on whether the QMS has been\u00a0<em>established and documented<\/em>, while the on-site audit looks at whether there is sufficient objective evidence within the QMS to confirm it has been\u00a0<em>implemented and maintained<\/em>.<\/p><p>A full QMS\u00a0<strong>audit\u00a0<\/strong>has four primary goals:<\/p><ol><li>Determine the extent to which the QMS has been established.<\/li><li>Determine whether or not the QMS has been documented in accordance with applicable requirements also known as\u00a0<em>audit criteria\u00a0<\/em>(e.g., ISO standard, applicable regulations, contracts).<\/li><li>Determine if the QMS has been effectively implemented.<\/li><li>Determine whether or not the QMS has been properly maintained.<\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63257b3 elementor-widget elementor-widget-image\" data-id=\"63257b3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"511\" height=\"238\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-System-Practices-Flow-72.png\" class=\"attachment-large size-large wp-image-1000\" alt=\"QMS Audit Goals\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-System-Practices-Flow-72.png 511w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-System-Practices-Flow-72-300x140.png 300w\" sizes=\"(max-width: 511px) 100vw, 511px\" \/>\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 class=\"elementor-element elementor-element-57578e8 elementor-widget elementor-widget-menu-anchor\" data-id=\"57578e8\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"audit-schedule\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f0f011 elementor-widget elementor-widget-heading\" data-id=\"0f0f011\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Developing Your Overall ISO 13485 Audit Schedule<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08bb4a2 elementor-widget elementor-widget-text-editor\" data-id=\"08bb4a2\" data-element_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<p>A well-planned audit schedule will ensure that audits are performed regularly, are conducted according to the importance of the process and address the results of previous audits.<\/p><p>Developing a master audit schedule is the first step toward planning audit activities for the year.\u00a0 Individual audit leaders will construct the individual audit plans to meet the schedule. An example of a master internal audit schedule is shown below. A similar one could be developed to plan your supplier audits for the year.<\/p><p><strong>A typical ISO 13485:2016 internal audit will generally cover 2-4 areas of the organization each month throughout the year, depending on the size of the company.<\/strong><\/p><p>\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59e67f3 elementor-widget elementor-widget-image\" data-id=\"59e67f3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"509\" height=\"254\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-Processes-Table-72.png\" class=\"attachment-large size-large wp-image-999\" alt=\"Audit Process Table - Sample\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-Processes-Table-72.png 509w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Audit-Processes-Table-72-300x150.png 300w\" sizes=\"(max-width: 509px) 100vw, 509px\" \/>\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 class=\"elementor-element elementor-element-da7677c elementor-widget elementor-widget-menu-anchor\" data-id=\"da7677c\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"qms-audit\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17b2a83c elementor-widget elementor-widget-heading\" data-id=\"17b2a83c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preparing for Your ISO 13485 QMS Audit<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fded163 elementor-widget elementor-widget-text-editor\" data-id=\"3fded163\" data-element_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<p>When planning an audit, it is tempting to skip some of the steps below and go immediately to creating a checklist and schedule. However, the process of initiating the audit is vital to assure the audit process is comprehensive and successful.<span style=\"background-color: transparent;\">Here are the steps you should take.<\/span><span style=\"background-color: transparent;\">\u00a0<\/span><\/p><ul><li><strong>Appoint the lead auditor.\u00a0<\/strong>The first basic step is to figure out who will lead the audit team. If you work for a small company, that might be you! This person will be responsible for all phases of the audit.<\/li><li><strong>Define audit objectives, scope, and criteria.\u00a0<\/strong>This is an important step. You need to define which facilities and\/or departments are involved and which processes will be audited and clearly identify those areas that may be excluded. Defining the audit criteria (i.e., ISO 13485:2016) and additional applicable regulatory requirements (e.g., 21 CFR 820 and\/or EU Medical Device Regulation 2017\/745) are also imperative.<\/li><li><strong>Determine the feasibility of the audit.\u00a0<\/strong>You need to ensure that you will be able to conduct the audit as planned. Will you have adequate cooperation from auditees? Are any of the people involved working on a major deadline that would take away from their participation? Will any of them be on vacation? Is there adequate time and budget to conduct the audit? Will all the information you need be made available to you? Don\u2019t assume. Verify.<\/li><li><strong>Select the audit team.\u00a0<\/strong>If your company is small, you may comprise the \u201cteam\u201d If your company has more than, say, 150 employees, insources design, makes high risk-products, etc., it is possible that you may need 2+ auditors on your team. In selecting the audit team members, consider which competencies are needed, how long your audit will last, the scope of the audit, and time constraints. The first rule of auditing is that an auditor cannot examine an area for which he\/she is responsible. Regarding competence, consider this example: An auditor who needs to interview management regarding management processes (e.g., resource processes, results processes, etc.) should have some minimal business experience. An auditor who needs to verify process or product measurements may need to have knowledge of quality and statistical tools. That\u2019s why ISO defines competence in terms of education, training, skill, experience, and personal attributes.<\/li><li><strong>Establish initial contact with the auditee(s).\u00a0<\/strong>With a lead auditor chosen, the team determined, the scope defined, and other factors considered, it\u2019s time establish contact with your auditees. Make sure affected members of your organization (or your supplier) understand the scope of the audit you are conducting, when the audit will be conducted, and who is on the team. Request access to all relevant documents and, if you are auditing a supplier, ask for a map or sketch of their facility that has the departments clearly labeled.<\/li><li><strong>Review your reference documents.<\/strong> Review any applicable standards or guidance documents to refamiliarize yourself with the requirements.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78d2a8f elementor-widget elementor-widget-menu-anchor\" data-id=\"78d2a8f\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"documentation-review\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4437ddb2 elementor-widget elementor-widget-heading\" data-id=\"4437ddb2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conducting a QMS Documentation Review<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a930c53 elementor-widget elementor-widget-text-editor\" data-id=\"6a930c53\" data-element_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<p><strong>The purpose of the documentation review is to determine whether or not the QMS has been established and documented <\/strong><strong>and meets the established regulatory requirements<\/strong>. <strong>\u00a0<\/strong>Accordingly, where possible, try to review all documentation before the on-site audit activities commence. This will help you prepare for the on-site audit effectively and efficiently. Typically, auditees are required to submit a quality manual and procedures before the on-site audit.<\/p><p>The documentation should cover relevant information regarding the QMS (e.g., scope, exclusions that may exist) and any additional requirements beyond ISO 13485 and applicable regulatory requirements (e.g., customer requirements and\/or supplier agreements). It should represent the documented quality management system as required by ISO 13485 in paragraphs 4.2.1 and 4.2.2 or other applicable criteria. If you are auditing a supplier, sometimes it might not be possible to get the quality manual ahead of time for proprietary reasons. If that\u2019s the case, allocate time for a review at the beginning of the on-site audit. Organizational charts are helpful, so make sure you get a copy.<\/p><p>In addition to the manual and procedures, review:<\/p><ul><li>Promotional literature and website pages<\/li><li>Previous audit findings and status of corrective actions<\/li><li>Supplier agreements (if auditing a supplier)<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-10a56f9 elementor-widget elementor-widget-menu-anchor\" data-id=\"10a56f9\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"lead-auditor\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16fe8642 elementor-widget elementor-widget-heading\" data-id=\"16fe8642\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Role of the ISO 13485 Lead Auditor<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1812748d elementor-widget elementor-widget-text-editor\" data-id=\"1812748d\" data-element_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<p><strong>Every audit has a lead auditor even if it\u2019s the only auditor!\u00a0<\/strong>This person represents the team in communication with the auditee and management. The lead auditor also defines the requirements of each audit assignment, including qualification of other audit team members. Here are some of the lead auditor\u2019s additional responsibilities:<\/p><ul><li>Plan the audit.<\/li><li>Assign audit responsibilities to each audit team member.<\/li><li>Make effective use of resources during the audit.<\/li><li>Organize and direct audit team members.<\/li><li>Provide direction and guidance to auditors in training.<\/li><li>Serve as the lead communicator between the audit team and auditee team.<\/li><li>Lead the audit team to reach conclusions.<\/li><li>Prevent and resolve conflicts during the audit.<\/li><li>Prepare and complete the audit report.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b13b2a6 elementor-widget elementor-widget-menu-anchor\" data-id=\"b13b2a6\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"audit-plan\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dd5a0b3 elementor-widget elementor-widget-heading\" data-id=\"dd5a0b3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Creating the QMS Audit Plan<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4f6e91 elementor-widget elementor-widget-text-editor\" data-id=\"a4f6e91\" data-element_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<p>Starting an on-site audit without a detailed plan is a surefire way to waste a lot of time, frustrate a lot of people, and leave without generating useful output. In an ideal world, you should spend 2 hours planning every hour of audit time. A detailed audit plan should cover:<\/p><ul><li>Audit objectives and scope<\/li><li>Audit criteria and reference documents<\/li><li>Locations, dates, times, and duration of audit activities<\/li><li>Audit method to be used, including the extent of sampling<\/li><li>Roles and responsibilities of the audit team members, guides, and observers<\/li><li>Allocation of appropriate resources to critical areas of the audit<\/li><li>Logistics and communications arrangements (usually for supplier audits)<\/li><\/ul><p><strong>This is an example of an internal audit plan for a single internal process.<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13c8002 elementor-widget elementor-widget-image\" data-id=\"13c8002\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"497\" height=\"261\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Single-Internal-Process-Audit-Table-72.png\" class=\"attachment-large size-large wp-image-1003\" alt=\"Audit Plan - Single Process\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Single-Internal-Process-Audit-Table-72.png 497w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Single-Internal-Process-Audit-Table-72-300x158.png 300w\" sizes=\"(max-width: 497px) 100vw, 497px\" \/>\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 class=\"elementor-element elementor-element-024d666 elementor-widget elementor-widget-text-editor\" data-id=\"024d666\" data-element_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<p><strong>This is an example of an ISO 13485:2016 audit plan for individual processes. It also shows the ISO 13485:2016 clauses that would typically be relevant for each process.<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a6b2836 elementor-widget elementor-widget-image\" data-id=\"a6b2836\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"299\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/BLOG-AUDIT-72.png\" class=\"attachment-large size-large wp-image-1007\" alt=\"Audit Plan - Processes\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/BLOG-AUDIT-72.png 600w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/BLOG-AUDIT-72-300x150.png 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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 class=\"elementor-element elementor-element-1b0f789 elementor-widget elementor-widget-heading\" data-id=\"1b0f789\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Creating Your Working Documents<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9fb18b elementor-widget elementor-widget-text-editor\" data-id=\"c9fb18b\" data-element_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<p>An essential part of the audit planning stage involves preparation of the working documents. You\u2019ll usually do some of this in parallel with the documentation review portion of the audit, which will give you information about specific topics and information paths to follow during your on-site audit.<\/p><p>Working documents typically include checklists, audit sampling plans and forms for recording meeting attendance, audit evidence, and audit findings (corrective action reports, nonconformity reports). Checklists are good tools, as they save valuable time and ensure that important items are not missed during the audit. It is worth spending time on these, because checklists can be adapted for use in other audits and improved based on your experience over time. Just remember: As you\u2019re auditing, don\u2019t use checklists like a script; instead, consider them only as a guide. Also, don\u2019t forget to safeguard and treat your audit documents as confidential or proprietary at all times.<\/p><p>\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-888bea4 elementor-widget elementor-widget-heading\" data-id=\"888bea4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Notifying Your Auditee<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-96398f8 elementor-widget elementor-widget-text-editor\" data-id=\"96398f8\" data-element_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<p>The final step in the preparation phase is to confirm the audit details with your auditee. This correspondence comes from the lead auditor and must follow company procedures and address all points from any previous phone discussions, meetings, or emails. The notification must confirm the date, time, and place of the opening meeting and include the audit plan and proposed schedule\/agenda. (Optionally, you could include a copy of your checklists if they will aid understanding, but there are pros and cons to doing so.) The purpose of this notification is to ensure there are no misunderstandings.<\/p><p><strong>A detailed audit plan will be very specific about times, participants, and process areas.<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd5b641 elementor-widget elementor-widget-image\" data-id=\"fd5b641\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"497\" height=\"388\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Detailed-Audit-Table-72.png\" class=\"attachment-large size-large wp-image-1010\" alt=\"Sample Audit Plan\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Detailed-Audit-Table-72.png 497w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Detailed-Audit-Table-72-300x234.png 300w\" sizes=\"(max-width: 497px) 100vw, 497px\" \/>\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 class=\"elementor-element elementor-element-8496526 elementor-widget elementor-widget-menu-anchor\" data-id=\"8496526\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"smoothly\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f6de522 elementor-widget elementor-widget-heading\" data-id=\"f6de522\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How to Ensure the Opening Day of Your ISO 13485:2016 Audit Goes Smoothly<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-95d116c elementor-widget elementor-widget-text-editor\" data-id=\"95d116c\" data-element_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<p>You have spent weeks preparing for your audit. All documentation has been reviewed, schedules created, auditees notified, and checklists confirmed. Now it\u2019s time for the scary part: Conducting the audit! If you have done your job well to this point, the audit should be the easy part because you will simply be executing a well-choreographed plan.<\/p><p>On the morning of Day 1, you will host the opening meeting. There are many things you will want to accomplish during this meeting, including:<\/p><ul><li>Record the name and title of all participants.<\/li><li>Introduce audit team members and state each member\u2019s responsibilities. Ask the auditee team to do the same.<\/li><li>Discuss the responsibilities of auditee management.<\/li><li>Confirm the purpose and scope of the audit and confirm the audit plan (typically sent a few weeks prior to the opening meeting).<\/li><li>Confirm the availability of all requested resources.<\/li><li>Describe the audit methodology (e.g., interviewing, observing, reviewing documentation, taking<\/li><li>notes, recording findings, classifying nonconformities, etc.).<\/li><li>State the audit objectives and emphasize that the audit will try not to interfere with operations.<\/li><li>Confirm the working hours, meal breaks, and time for daily debriefings.<\/li><li>Confirm the time of the closing meeting, and state how long it will take after that meeting until the audit report is issued.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c8d1480 elementor-widget elementor-widget-menu-anchor\" data-id=\"c8d1480\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"audit-duration\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-096b1b7 elementor-widget elementor-widget-heading\" data-id=\"096b1b7\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Average ISO 13485 Internal Audit Duration<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6cc899 elementor-widget elementor-widget-text-editor\" data-id=\"d6cc899\" data-element_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<p>The duration of an audit is based on the number of employees in the facility and the scope of the QMS. The risk associated with the device is also a factor. For example, there is certainly more risk associated with manufacturing heart valves than manual wheelchairs, and this impacts audit length. The International Accreditation Forum documents MD-5 and MD-9 set guidelines for internal audit days as well as general protocols for conducting an ISO audit. It should be noted, however, that this type of audit length determination is trending out with the use of audit duration calculations used in the Medical Device Single Audit Program Model (MDSAP). MDSAP audits are based on the number of elements to be covered in the audit. These types of audits can be considerably longer than an ISO audit.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a84960d elementor-widget elementor-widget-menu-anchor\" data-id=\"a84960d\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"rabbit-holes\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dfbd3bb elementor-widget elementor-widget-heading\" data-id=\"dfbd3bb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conducting the On-Site Audit and Avoiding Rabbit Holes<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2249b0f elementor-widget elementor-widget-text-editor\" data-id=\"2249b0f\" data-element_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<p>All that preparation you did in the weeks leading up to the audit will now pay off. You should make every effort to deal directly with the people involved in implementing the system. People \u2013 not documents \u2013 make or break a system. When you start performing the audit, it is important to remember that an audit is really a method of sampling and is conducted to get a sense of what is happening. Consider stratified random sampling to focus the audit based on risk (e.g., rather than taking a random sampling of purchase orders, stratify the population by criticality to focus on what is important). You need to be sure that the auditee is not cherry-picking documents to show you. You should dictate the documents you want to see, reviewing the requisite number of samples stipulated in your audit plan.<\/p><p>During the audit, you will invariably come across people who nervously ramble, digress, or are intentionally vague or evasive. In these cases, it is important that you remain courteous but persistent. Be polite but insist on getting details needed to answer the question. Don\u2019t go down the rabbit hole with someone who is trying to explain something that is irrelevant. It is the auditor\u2019s job to keep the auditee on track and extract the information needed. That being said, you should explore problems fully. Accordingly, you may need to go beyond your checklist to dig deeper and look at key process interactions that may be relevant (e.g., purchasing and production interaction).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e51139d elementor-widget elementor-widget-menu-anchor\" data-id=\"e51139d\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"interview-tips\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0473d5 elementor-widget elementor-widget-heading\" data-id=\"d0473d5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Audit Interviewing Tips<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35f0042 elementor-widget elementor-widget-text-editor\" data-id=\"35f0042\" data-element_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<p>Auditees often get nervous during an ISO 13485:2016 audit because they sometimes feel as though they are being personally interrogated. To gain their cooperation, it is important that you set a commonality of perceived purpose in the opening meeting. Your common goal is to ensure that the company has a quality management system that is conforming to requirements and effective, not to throw someone under the bus. Make sure to tell the auditee that you will be taking notes during an interview. Refer to your checklists repeatedly but don\u2019t read verbatim from them; instead, use the checklist items as a framework for discussion. To get relevant, complete information from auditees,<\/p><p>follow these guidelines:<\/p><ul><li>Don\u2019t be sarcastic, argue, or criticize people\u2019s efforts.<\/li><li>Don\u2019t be negative.<\/li><li>Don\u2019t reveal your opinions but don\u2019t be overly secretive.<\/li><li>Don\u2019t question beyond your level of knowledge.<\/li><li>Don\u2019t get into company politics or personalities.<\/li><li>Don\u2019t be late!<\/li><\/ul><p>Remember, although the audit may be the most important thing in your professional life at this moment and you may feel like the most powerful person in the room, your presence is an imposition for the auditee. They have other work to do. With limited time to collect the information you need, think carefully about how you ask questions. Consider these alternative examples:<\/p><ul><li>Do you issue new revisions?<\/li><li>How do you issue new revisions?<\/li><\/ul><p>The second question (i.e., an open question) is likely to reveal much more information about who, what, when, where, why, and how revisions are issued. Also, keep personnel dynamics in mind. Auditee personnel may hold back information if their boss is also in the room.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec0d8e elementor-widget elementor-widget-menu-anchor\" data-id=\"2ec0d8e\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"observations\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5957bc4 elementor-widget elementor-widget-heading\" data-id=\"5957bc4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Recording and Discussing Your Observations<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53396cd elementor-widget elementor-widget-text-editor\" data-id=\"53396cd\" data-element_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<p>Audits can be exhausting, and you\u2019ll be eager to go home at the end of a long day. Resist the urge! It is vital that you conduct a debriefing at the end of each day (not the next morning) to discuss observations with your audit team members and ensure that team members are performing their assigned functions. Document your observations so each team member can evaluate results for potential nonconformities. Also, you\u2019ll sleep better that night with all of your insights safely put on paper instead of cluttering your brain.<\/p><p>Don\u2019t meet only with your audit team. It is important that you keep the auditee fully aware of what is being observed. Meet with the auditee per an established schedule for debriefing and report good as well as nonconforming conditions.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-016caeb elementor-widget elementor-widget-menu-anchor\" data-id=\"016caeb\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"closing-meeting\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-685e598 elementor-widget elementor-widget-heading\" data-id=\"685e598\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conducting the Closing Meeting of Your ISO 13485 Internal Audit<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab11260 elementor-widget elementor-widget-text-editor\" data-id=\"ab11260\" data-element_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<p>When the audit is complete, the audit team will conduct a closing meeting with the management team to formally present positive findings, cite concerns, share opportunities for improvement, and clarify misunderstandings. This meeting and the final ISO 13485 audit report are critical to the success of the audit, so the lead auditor must be fully prepared with notes covering all areas and have supporting objective evidence for each finding.<\/p><p>The purpose of the closing meeting is to present logical and fact-based explanations of the strengths and weaknesses of the quality management system. You will want to explain to management that the audit investigated only a sample of activities and that there may be other nonconformities the sampling did not uncover. This is especially important for people to understand because an actual FDA inspection or Notified Body audit may uncover different issues. You don\u2019t want people pointing fingers at you if observations arise that were not revealed by an internal audit.<\/p><p>With regard to nonconformities, it is best not to raise these for the first time during closing meetings. Always bring the issue up during the audit and give the auditee an opportunity to explain something you may have misunderstood. If there is still evidence of a nonconformity, let the auditee know then. Also, make sure you give credit where credit is due, particularly in areas where procedures have been shown to be effective. When covering deficiencies, focus the auditee\u2019s attention on the significance of the nonconformities (major versus minor). Get agreement on a timeframe for creating a corrective action plan, and a deadline for addressing those deficiencies. You should also state the date when the final audit report will be issued. Finally, although not required (especially with internal audits), it\u2019s a good idea to keep minutes of the meeting and record attendance.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-746266b elementor-widget elementor-widget-menu-anchor\" data-id=\"746266b\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"now-what\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1df2f58 elementor-widget elementor-widget-heading\" data-id=\"1df2f58\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Whew. You Successfully Finished Your ISO 13485 Internal or Supplier Audit. Now What?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b430eb2 elementor-widget elementor-widget-text-editor\" data-id=\"b430eb2\" data-element_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<p>You\u2019ve spent weeks preparing for your audit and several days conducting it. Now comes the time to formally put your thoughts and findings on paper. The purpose of the audit report is to present the auditee with a written record of nonconformities and provide a full account of audit evidence that supports these nonconformities. In general, your audit report should:<\/p><ul><li>Describe the audit purpose and scope.<\/li><li>Identify all audit team members.<\/li><li>Identify people who attended the opening and closing meetings.<\/li><li>Describe the strengths of the QMS.<\/li><li>Describe each system nonconformity.<\/li><li>Typically, people\u2019s names are not linked to process nonconformities, only to their job function (e.g., supervisor, etc.).<\/li><li>Provide audit evidence to support each nonconformity.<\/li><li>Describe concerns and opportunities for improvement.<\/li><li>Provide a conclusion (e.g., \u201cThe audit shows that the QMS has remained effective with a few exceptions, as revealed by the nonconformities as follows\u2026\u201d).<\/li><\/ul><p>Don\u2019t forget \u2013 your report should not contain surprise nonconformities that were not discussed during the audit and in the closing meeting.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f415adf elementor-widget elementor-widget-menu-anchor\" data-id=\"f415adf\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"final-report\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1353594 elementor-widget elementor-widget-heading\" data-id=\"1353594\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Much Detail Goes into the Final Audit Report?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c9aba4 elementor-widget elementor-widget-text-editor\" data-id=\"1c9aba4\" data-element_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<p>The nature of the audit will determine the characteristics such as the length, format, emphasis areas, and sequence. Nonetheless, the formal report should contain a highly detailed description of the quality management system\u2019s strengths, nonconformities, audit evidence, opportunities for improvement, and areas of concern. It should include:<\/p><ul><li>Executive summary<\/li><li>Audit overview, including:<\/li><li>Date of the audit<\/li><li>Purpose of the audit and scope<\/li><li>Audit criteria (e.g., ISO 13485:2016 standard)<\/li><li>Persons contacted during the audit and the audit team<\/li><li>Approvals and signoff by lead auditor<\/li><li>Specific nonconformity reports<\/li><li>Specific concern reports (could become future nonconformities)<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4ab07e elementor-widget elementor-widget-image\" data-id=\"c4ab07e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"206\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Nonconformity-Concern-Tables-72.png\" class=\"attachment-large size-large wp-image-1001\" alt=\"Nonconformity-Concern Tables\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Nonconformity-Concern-Tables-72.png 675w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Nonconformity-Concern-Tables-72-300x96.png 300w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\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 class=\"elementor-element elementor-element-09b3c96 elementor-widget elementor-widget-text-editor\" data-id=\"09b3c96\" data-element_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<p>The content of the ISO 13485 QMS audit report must represent the conclusions of the lead auditor with input from the entire audit team, and not just the viewpoints of individuals. This gives the auditee the benefit of the collective experience of all team members and reduces bias.<\/p><p>The lead auditor will decide if the scope of the audit warrants including corrective action requests in the final report. Your audit report should be sent to the auditee as soon after the closing meeting as practical. This is important because it reinforces the points you made during the closing meeting and keeps those issues top of mind with the auditee management team.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68cdaae elementor-widget elementor-widget-menu-anchor\" data-id=\"68cdaae\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"follow-up\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e42e01 elementor-widget elementor-widget-heading\" data-id=\"3e42e01\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485 Internal or Supplier Audit Follow-Up Activities<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85b5785 elementor-widget elementor-widget-text-editor\" data-id=\"85b5785\" data-element_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<p>Now that you\u2019ve crafted a beautifully detailed report and submitted it to the auditee, you\u2019re finished \u2013 right? Not so fast. The last thing you want is to show up at the next audit only to find out that nothing has been done to address nonconformities described in your audit report. Inaction would certainly frustrate you and it would not be good for the company. Thus, after the closing meeting has occurred and the audit report has been sent to management, your goals are to:<\/p><ul><li>Ensure the management team fully understands the nonconformities via audit report distribution.<\/li><li>Make sure the auditee prepares timely corrective action plans to address any nonconformities<\/li><li>Ask the auditee to identify the people who will initiate and implement the corrective actions.<\/li><li>Evaluate the auditee\u2019s corrective action plan responses to determine the completeness of the plan.<\/li><li>Verify the completion and effectiveness of corrective actions, which may include a follow-up audit.<\/li><li>Determine the need for surveillance visits.<\/li><\/ul><p>It\u2019s also a good idea to make sure the organization has a methodology to address corrective actions. If not, this would be a good opportunity for improvement. Without a methodology supported by tools, chances are that the CAPA system will not be effective.<\/p><p>As part of the follow-up process, you should also retain or destroy documents pertaining to the audit in accordance with any agreements, procedures, and applicable statutory, regulatory, and contractual requirements.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-327d08c elementor-widget elementor-widget-heading\" data-id=\"327d08c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your Work Will Never Be Done, and That\u2019s Good<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fda44bc elementor-widget elementor-widget-text-editor\" data-id=\"fda44bc\" data-element_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<p>As an auditor, you play a critical role in the health of your organization\u2019s quality management system, and ultimately the safety of the medical devices your company produces. That\u2019s an important responsibility, which needs to be taken seriously. The benefits of sustained audits are much the same as eating healthfully or exercising. It may not always feel great right away, but the long-term results are always positive.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5051bdf elementor-widget elementor-widget-heading\" data-id=\"5051bdf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to take the next step in becoming an ISO 13485 auditor?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1418523 elementor-widget elementor-widget-text-editor\" data-id=\"1418523\" data-element_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<p class=\"MsoNormal\" style=\"line-height: 18.0pt; mso-line-height-rule: exactly; background: white; mso-background-themecolor: background1; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt;\">This blog only scratches the surface of the topic. If you will be more involved in doing audits for your organization, we highly recommend you check out our <\/span><span style=\"color: black; mso-color-alt: windowtext;\"><a href=\"https:\/\/www.orielstat.com\/courses\/lead-auditor-training-for-ISO-13485\">ISO 13485 lead auditor training<\/a><\/span><span style=\"font-size: 10.5pt;\"> class, which offers the opportunity to become certified by Exemplar Global. Our team is also available to conduct internal and supplier audits as needed.\u00a0<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-375d07a3 elementor-widget elementor-widget-shortcode\" data-id=\"375d07a3\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>How to Prepare for and Conduct an ISO 13485 Internal QMS Audit Covered in this guide: \u00a0 Real Purpose of the Medical Device QMS AuditBasic Types of ISO 13485 Audits\u00a0Developing Your Overall ISO 13485 Audit SchedulePreparing for Your ISO 13485:2016 QMS AuditConducting a QMS Documentation ReviewRole of the ISO 13485 Lead AuditorCreating the QMS Audit [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2615,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[4,28],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/planning-iso-13485-audit\/\" 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