ISO 13485 Quality Management System
AWARENESS TRAINING FOR STAFF
(1 Day of 7 hrs)

This course is designed for staff who want to understand what is ISO 13485:2003 standard and what it takes to successfully implement the standard.

This course is also designed for management as part of the Consultancy Package to educate the management staff on the international standard and the consultancy approach and project phases that will lead the organisation to certification.

• To raise levels of awareness and understanding of the ISO 13485:2003 quality management system requirements.
  
  
• To provide an understanding of the key factors associated with successful implementation of the ISO 13485:2003 quality management system.
  
  
• To provide an understanding of the methodology for implementing the ISO 13485:2003 system.

• What is ISO
  
• 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
  
• Benefits of implementing ISO 13485:2003
  
• Guidelines for implementing ISO 13485:2003 system
  
• ISO 13485:2003 implementation methodology
  
• Role of staff