Lead Auditor: ISO 13485

Our ISO 13485 Medical Devices Lead Auditor training course will provide you with the information and skills you need to lead a comprehensive quality system audit that complies with ISO 13485, ISO 9001 and regulatory requirements. Guide your organisation towards quality management excellence and ISO 13485 certification, remove barriers to market for your medical devices, and gain competitive advantage.

Work with our expert trainers over five days to consolidate your knowledge of ISO 13485 and ISO 19011 and understand the entire audit process. You’ll learn how to structure, plan, and time an effective audit, as well as how to evaluate and communicate the audit findings. Learn about the concepts of risk management (ISO 14971) and its integration with the audit approach. Practical workshops, interactive case studies, and simulated assessments are used to develop your leadership and specialist auditing skills.

This course is an International Register of Certificated Auditors (IRCA) certified training course.

As a prerequisite, this course requires knowledge of both ISO 9001 and ISO 13485. If you need to improve your knowledge in either of these subjects, we recommend the ISO 9001 Requirements training course and the Introduction to ISO 13485 training course.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Anyone involved in implementing and/or auditing quality management systems for medical devices

Learning objectives

  • Understand ISO 13485 within the context of an audit
  • Gain an overview of the purpose and content of the ISO 9000 series
  • Define Quality Management Systems (QMS) and how audits support the system
  • Key principles of planning and controlling audits of quality management systems for medical devices.
  • Lead follow up action on ISO 13485 and ISO 19011 audits

Course Benefits

  • Benefit from effective ISO 13485 audits and compliance
  • Maintain and improve quality standards with regular audits
  • Increase credibility and competitive advantage
  • Become confident in conducting opening and closing meetings tailored to the medical device industry.

Next Steps

  • Introduction to: CE Marking training course - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.