ISO 13485 Lead Auditor Practitioner Qualification

This first step on your auditor qualification journey is designed for senior management, regulatory affairs or quality managers, internal and external auditors with a need to understand the full requirements of the ISO 13485:2016 Quality Management System (QMS) standard. You’ll learn everything you need to become a Lead Auditor Practitioner, including how to manage an audit programme, how to apply risk-based thinking, and how to show leadership.

Expert BSI trainers will guide you on your learning journey and show you how to identify the aims and benefits of an ISO 13485:2016 QMS audit. You’ll also learn how to monitor supply chains to achieve continuous improvement, and how to develop safe and effective medical devices.

How will I benefit?

  • In-depth understanding of how the ISO 13485:2016 interacts with the ISO 9001:2015
  • Discover ways to increase efficiency and cost savings via quality management
  • Learn how to build stakeholder confidence by understanding the up-to-date requirements
  • Gain formal recognition of your knowledge and learn how to directly apply your skills in your organization
  • Contribute to your career progression and unlock access to a wider range of higher-level and more advanced specialized qualifications
  • Engage with a global community of fellow qualified professionals to share experiences and practical advice to use in your everyday life

Which qualification will I achieve?

On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared across within your organization and across your network of contacts.