ISO 13485 Lead Auditor

Duration : 5 Days (40 Hours)

ISO 13485 Lead Auditor Course Overview

The ISO 13485 Lead Auditor certification is a globally recognized standard designed to evaluate the competence of medical device manufacturers. It focuses on quality management systems, meeting regulatory and customer requirements, and achieving excellence in device safety and performance. Companies pursue ISO 13485 certification to ensure regulatory compliance, mitigate risks, enhance efficiency, and promote continuous improvement. The certification process involves a third-party auditor, who plays a crucial role in assessing the organization’s adherence to ISO 13485 standards, identifying any nonconformities, and suggesting corrective actions. The Lead Auditor position holds significant importance as it requires comprehensive knowledge and skills in auditing and the ISO 13485 standards.

Intended Audience

  • Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits 
  • Managers or consultants seeking to master a Medical Devices Quality Management System audit process
  • 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 Objectives of ISO 13485 Lead Auditor

  • 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

Benefits of taking ISO 13485 Lead Auditor Training

By taking the ISO 13485 Lead Auditor Training, you will gain a comprehensive understanding of the ISO 13485 standard and its requirements, allowing you to effectively assess and audit QMS compliance in the medical device industry. Additionally, you will develop the proficiency to plan, conduct, and report ISO 13485 audits, enabling you to identify and address QMS nonconformities and prepare for ISO 13485 certification audits. Furthermore, this training will keep you up-to-date with the latest ISO 13485 requirements and industry best practices, empowering you to advance your career in medical device quality assurance and regulatory compliance. Ultimately, by contributing to patient safety and public health, you will play a vital role in ensuring the safety and efficacy of medical devices.

In summary, ISO 13485 Lead Auditor Training offers a range of benefits for professionals in the medical device industry, enhancing their expertise, career prospects, and ability to contribute to patient safety and public health.

 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)
  • 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)
  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports
  • 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

ISO 13485 Lead Auditor Course Prerequisites:

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

Discover the perfect fit for your learning journey

Choose Learning Modality

Live Online

  • Convenience
  • Cost-effective
  • Self-paced learning
  • Scalability


  • Interaction and collaboration
  • Networking opportunities
  • Real-time feedback
  • Personal attention


  • Familiar environment
  • Confidentiality
  • Team building
  • Immediate application

Training Exclusives

This course comes with following benefits:

  • Practice Labs.
  • Get Trained by Certified Trainers.
  • Access to the recordings of your class sessions for 90 days.
  • Digital courseware
  • Experience 24*7 learner support.

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