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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

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