This advanced course is designed for professionals in the medical device industry who are responsible for planning, leading, and conducting external audits of Quality Management Systems (QMS) in accordance with ISO 13485:2016 and ISO 19011 auditing guidelines. It equips delegates with expert-level auditing techniques, a thorough understanding of regulatory compliance, and the ability to lead audit teams effectively within a global medical device context.

Package for Delegates

• ISO 13485:2016 & ISO 19011 Reference Materials
• Comprehensive Lead Auditor Audit Plan & Report Templates
• Real-life Industry Case Studies & Complex Audit Scenarios
• Lunch & Refreshments (In-person only)
• Access to Mock Lead Audits & Group Role-play Exercises
• Certificate of Completion
• Final Examination & Continuous Assessment

Examination

Delegates will be assessed through a combination of a theory-based final exam, continuous practical assessments, and group audit exercises. Upon successful completion, participants will receive the ISO 13485:2016 Lead Auditor Certificate, validating their ability to lead and manage full-system audits within the medical device sector.

Accreditation

Delivered by certified instructors from IRCA-approved training providers, this course aligns with international auditing standards under ISO 19011 and is recognized globally by regulatory bodies and organizations in the medical device industry.

Variety of Jobs with this Course

Graduates of this course are equipped for senior auditing and quality management roles, including:

• Lead Auditor – Medical Devices
• Quality Systems Manager
• Regulatory Affairs Lead
• Global Compliance Auditor
• Supplier Audit Manager
• Senior Quality Assurance Engineer