ISO 13485 Lead Auditor Certification Training Course Overview

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.

Target Audience

  • Auditors 
  • Managers or consultants 
  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit
  • Expert advisors in Medical Devices Quality Management

Learning Objective

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to lead an audit and audit team
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • 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

ISO 13485 Lead Auditor (40 Hours) Download Course Contents

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Group Training 1700
01 - 05 Nov GTR 09:00 AM - 05:00 PM CST
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06 - 10 Dec 09:00 AM - 05:00 PM CST
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Course Modules

Module 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
  • Course objectives and structure
  • Standards and regulatory frameworks
  • Certification process
  • Fundamental principles of Medical Devices Quality Management Systems
  • Medical Devices Quality Management System (QMS)
Module 2: Audit principles, preparation and launching of an audit
  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)
Module 3: On-site audit activities
  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports
Module 4: Closing the audit
  • Documentation of the audit and its review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training
Module 5: Certification Exam
  • Details are not available.
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Course Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.