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

Live Virtual Classroom Fee For Both Group Training & 1-on-1 Training On Request
Group Training
08 - 12 Aug 09:00 AM - 05:00 PM CST
(8 Hours/Day)

06 - 10 Sep 09:00 AM - 05:00 PM CST
(8 Hours/Day)

1-on-1 Training (GTR)
4 Hours
8 Hours
Week Days
Week End

Start Time : At any time

12 AM
12 PM

GTR=Guaranteed to Run
Classroom Training (Available: London, Dubai, India, Sydney, Vancouver)
Duration : On Request
Fee : On Request
On Request
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Course Prerequisites

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