{"id":1224,"date":"2024-06-21T19:42:09","date_gmt":"2024-06-21T19:42:09","guid":{"rendered":"https:\/\/kekeliacademy.com\/?post_type=product&#038;p=1224"},"modified":"2025-04-06T00:46:00","modified_gmt":"2025-04-06T00:46:00","slug":"self-paced-pecb-iso-13485-lead-auditor","status":"publish","type":"product","link":"https:\/\/kekeliacademy.com\/en\/product\/self-paced-pecb-iso-13485-lead-auditor\/","title":{"rendered":"Self Paced PECB ISO 13485 Lead Auditor"},"content":{"rendered":"<p><strong>Buy this Self Paced training course<\/strong>\u00a0(at your own pace) and receive the courses, quizzes, exercises and the code to take the exam within a period of 1 year<\/p>\n<p>The option\u00a0<strong>Self Paced<\/strong>\u00a0gives you :<\/p>\n<ul>\n<li><strong>Self-paced online course support in the KATE web or desktop application<\/strong>\u00a0with exercises and quizzes and their answers<\/li>\n<li><strong>The exam voucher with a retake\u00a0<\/strong>: you will have one year to take the exam from the moment the voucher is generated<\/li>\n<li><strong>PECB certification\u00a0<\/strong>: you will receive your certification as soon as you have validated your exam and fulfilled the necessary conditions<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">ISO 13485 Lead Auditor<\/h2>\n<p>ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.<\/p>\n<h3 class=\"wp-block-heading\">Why should you attend?<\/h3>\n<p>During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO\/IEC 17021-1 certification process.<\/p>\n<p>Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.<\/p>\n<p>After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a \u201cPECB Certified ISO 13485 Lead Auditor\u201d credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.<\/p>\n<h3 class=\"wp-block-heading\">Who can Attend?<\/h3>\n<ul>\n<li>Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits<\/li>\n<li>Managers or consultants seeking to master a Medical Devices Quality Management System audit process<\/li>\n<li>Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements<\/li>\n<li>Technical experts seeking to prepare for a Medical Devices Quality Management System audit<\/li>\n<li>Expert advisors in Medical Devices Quality Management<\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\">Learning objectives<\/h3>\n<ul>\n<li>Understand the operations of a Medical Devices Quality Management System based on ISO 13485<\/li>\n<li>Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks<\/li>\n<li>Understand an auditor\u2019s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011<\/li>\n<li>Learn how to lead an audit and audit team<\/li>\n<li>Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit<\/li>\n<li>Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011<\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\">Educational approach<\/h3>\n<ul>\n<li>This training is based on both theory and best practices used in MDQMS audits<\/li>\n<li>Lecture sessions are illustrated with examples based on case studies<\/li>\n<li>Practical exercises are based on a case study which includes role playing and discussions<\/li>\n<li>Practice tests are similar to the Certification Exam<\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\">Prerequisites<\/h3>\n<p>A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.<\/p>\n<div id=\"gtx-trans\" style=\"position: absolute; left: 652px; top: 394.927px;\">\n<div class=\"gtx-trans-icon\"><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p><strong>Buy this Self Paced training course<\/strong>\u00a0(at your own pace) and receive the courses, quizzes, exercises and the code to take the exam within a period of 1 year<\/p>","protected":false},"featured_media":1463,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"product_brand":[],"product_cat":[36],"product_tag":[37,79,81,39],"class_list":{"0":"post-1224","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-none","7":"product_tag-certification-iso","8":"product_tag-laboratory","9":"product_tag-pecb-iso-13485-lead-auditor","10":"product_tag-voucher","11":"desktop-align-left","12":"tablet-align-left","13":"mobile-align-left","15":"first","16":"instock","17":"sale","18":"taxable","19":"shipping-taxable","20":"purchasable","21":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/product\/1224","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/comments?post=1224"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/media\/1463"}],"wp:attachment":[{"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/media?parent=1224"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=1224"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=1224"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/kekeliacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=1224"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}