ISO 13485 Lead Auditor Course

Last Updated: 22 08 2025

This extensive ISO 13485 main auditor course equates ISO 13485: 2016 and ISO 19011: 2018, equipped with expertise to direct the revision of medical equipment quality management systems in adjustment. The course, regarded as the best training company for ISO standards, ensures mastery through a mix of the program's workshops, interactive case studies and simulations of the Real World. Learners will develop important skills in audit planning, team coordination, evaluation, Enovation reporting and audit conclusion. Special emphasis is placed on the implementation of risk-based and procedure-based audit methods, opening and administration of closing meetings and preparation of practical audit reports. 

The course is by exemplary global qualifying units - MD (Medical Devices system), AU (auditing Management System), TL (Lead Audit Team) - successful candidates are recognised with certification. The course is designed for the industry's professionals to consider the Best Business Training Company for quality management, which provides analogous learning experiences for managers of regulatory and quality compliance. 

This course is ideal for quality leaders, match managers, internal auditors and third-party auditor roles, and requires an acquaintance with ISO 13485: 2016 (a copy of the standard). Towards the end, Learners will safely lead the internal, supplier and certification audit, and strengthen the emergency preparedness to comply with their organisation and regulatory assessment.

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Learning Options for You

  • Live Training (Duration : 40 Hours)
  • Per Participant

Fee: On Request

Course Prerequisites

There are no formal prerequisites for attending this course. However, it is recommended that participants have a basic understanding of quality management concepts and ISO 13485 principles. Prior auditing experience is helpful but not required. 

  • Familiarity with medical device industry practices and regulations. 
  • Basic knowledge of QMS principles and ISO 13485:2016 standard. 
  • Awareness of auditing processes and techniques (helpful but not mandatory). 

Learning Objectives

By completing this course, participants will gain a solid understanding of ISO 13485:2016 requirements and develop the competence to audit QMS effectively. They will learn how to lead audit teams, evaluate conformity, report findings, and contribute to continual improvement in the medical device industry. 

  • ISO 13485:2016 structure, principles, and key requirements. 
  • Understanding the regulatory context of medical device QMS. 
  • Audit principles, techniques, and guidelines (ISO 19011 & ISO/IEC 17021). 
  • Planning, preparing, and conducting audits effectively. 
  • Leading an audit team and managing audit programs. 
  • Identifying nonconformities and ensuring corrective actions. 
  • Supporting organizations in maintaining regulatory and customer compliance. 

Target Audience

This course is ideal for professionals working in the medical device industry or certification bodies who are responsible for auditing or managing quality management systems. It is also suitable for consultants, advisors, and managers aiming to improve organizational compliance and performance in the healthcare sector. 

  • Internal and external auditors of medical device QMS. 
  • Quality managers, engineers, and officers in medical device companies. 
  • Regulatory and compliance professionals in healthcare. 
  • Consultants and advisors in QMS and regulatory affairs. 
  • Professionals aspiring to work as ISO 13485 certification auditors. 

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