ISO 13485 Quality Management System
INTERNAL AUDITOR TRAINING
(3 Days of 7 hours each day)

This course is designed to satisfy the training requirement for individual performing internal audit to the ISO 13485:2003 standard.

The objective of this training course is to train participants to understand, develop and implement an in-house quality audit programme, which fulfils the requirements for Internal Audit.

• Introduction of Quality Principles, definitions, process approach and ISO 13485:2003 Quality Management System
  
• Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
  
• Implications of changes to ISO 13485, and how they will affect your company
  
• Regulators’ approach to the ISO 13485:2003 requirements
  
• Explanation of the risk management (ISO 14971) requirements
  
• Interpretation of ISO 13485:2003 requirements
  
• Types of audits
  
• Objectives of Internal Auditor Training Programme
  
• Responsibility and Authority of the Audit Team
  
• Planning, Preparing and Performing an Audit
  
• Auditing Skills and Documenting Non-conformities
  
• Corrective Actions and Follow-up
  
• Audit Reporting
  
• Case Studies and Exercise
  
• Exam