ISO 13485 On-site Training Agenda

Day One

• Introductions

• Format of ISO 13485:2003 Standard

• Structure of the standard

• Contents and purpose of the sections

• Correspondence to and differences between ISO 9001:2000

• Introduction section

• Process approach - exercise

• Overview section

• Scope

• Application

• Exclusions – exercise

• Normative references

• 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

• Implementation / Optimization strategies

• Implementation / Optimization – group assignment and exercise

• ISO 13485:2003 Training Course summary and questions

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