ISO 13485 2003 On-site Training Agenda

Day One

• Introductions: participants, instructor

• Format of ISO 13485:2003 Standard

• Structure of the standard

• Contents and purpose of the sections

• Introduction section
  - ISO 13485 process approach - exercise

• Overview section

• Scope

• Application
  - Exclusions – exercise

• Normative references

• ISO 13485 terms and definitions

• Requirements - 4 Quality management system
  - Process interaction - exercise

• Lunch

• Requirements - 5 Management responsibility
  - Communication process - exercise

• Requirements - 6 Resource management
  - Infrastructure – exercise

• Requirements - 7 Product realization

• Day one summary and questions

Day Two

• Requirements - 7 Product realization (continued)

• Requirements - 8 Measurement, Analysis and improvement
  - Audit checklists — exercise
  - Process audit — exercise

• Lunch

• Requirements - 8 Measurement, Analysis and improvement (continued)
  - Analysis of data exercise

• ISO 13485 2003 implementation / optimization strategies

• Implementation / optimization – group assignment and exercise

• ISO 13485:2003 Training Course summary and questions

Order your ISO 13485:2003 Training today and Call us to schedule your training.