Content Overview :

• Intent Comprehension of the Standard
• Terms, Definitions and Concepts
• Format of new 13485:2003 Standard
• Direct comparison of ISO 9001:2008 to ISO 13485:2003
• Major changes from previous revision, differences, and relationships.
• Understand Linkages between 13485 and GMPs
• Process Approach and System Approach concepts
• Process Approach methods in Internal Auditing
• Understand the Role of Management during Implementation
• Powerful Implementation Techniques to minimize implementation difficulties

Who Should Attend :

• All Employees involved in developing, implementing and maintaining a Quality Management System including:
  • ISO Management Representative
  • Business Managers
  • Supervisors and Staff
  • Auditors of Medical Device

Student Material :

• ISO 13485 and Related Standard
• Student Workbook

Fees and General :

• Fee: US $495
• One Day of instruction and discussion