Transitioning to an ISO 13485 Quality Management System (Two-Day)

OUTLINE (Return to Main)

Day One

1. Introduction
   1. Objectives
2. Defining a quality system
   1. Prevention
   2. Implementation
   3. Effectiveness
   4. ISO 13485:2003 
3.  
   1. Policy statement
   2. Operating procedure
   3. Work instructions
   4. Quality objectives/measurables 
4. Understanding ISO 13485
   1. New language
   2. Management's role 
   3. Process-based system
      1. Important points
      2. Needed procedures
      3. Records and work instructions

Day Two

1. Developing documentation
   1. Flow-charting your process
   2. Transitioning from level I
2. Internal auditing issues  
   1. Auditing a process-based system
   2. Managing the audit system

Return to Main