ISO 13485:2016 Lead Auditor Course

Description

In this comprehensive course, participants will gain an in-depth understanding of the ISO13495:2016 and ISO19011 standards and their application in the Medical Device Industry. Through a combination of lectures, practical exercises, and case studies, participants will become proficient as ISO13485:2016 Lead Auditors.Key topics covered in the course include:

• ISO13485:2016 Standard
• Principles of Auditing – ISO 19011
• Audit planning, preparation, and execution
• Documentation review and assessment
• Audit reporting and corrective action follow-up
• Ethical considerations and professional conduct in auditing
• Conflict resolution during an audit
• Leading Audit Teams
• Case studies and real-world examples