Lead Auditor ISO 13485 Training Course

Take the lead in quality management for medical devices with our Lead Auditor ISO 13485 Training Course. Guide your organisation towards quality management excellence and ISO 13485 accreditation – and remove barriers to market for medical devices, gaining competitive advantage.

Work with qualified tutors over five days to consolidate your knowledge of ISO 13485 and ISO 19011:2002. Understand the entire audit process at lead level, from planning to managing and reporting on results and learn through tutorials and practical exercises to become a recognised auditing professional for ISO 13485 and ISO 19011.

"We are proud to have the standard. It gives us enormous credibility with our potential customer base and with that credibility we give them confidence."

You will take away the leadership and specialist auditing skills to help others understand and implement effective quality management systems in medical device manufacturing.

Learning objectives

• Understand ISO 13485 within the context of an audit
• Gain an overview of the purpose and content of the ISO 9000 series
• Study the eight principles of quality management
• Clarify your role in planning, conducting and reporting on ISO 13485 and ISO 19011 audits
• Lead follow up action on ISO 13485 and ISO 19011 audits
• Be confident managing internal or third party auditors.

Benefits of attending this course?

• Benefit from effective ISO 13485 audits and compliance
• Maintain and improve quality standards with regular audits
• Be confident that your organisation can rely on ISO certified lead auditors 
• Increase credibility and competitive advantage
• Motivate employees through CPD and build your customer base.