To give guidance and practical advice in interpreting, establishing and implementing a Quality Management System according to ISO 13845:2003 Standard.
- Concept of Quality Principles, definitions, process approach
- Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
- Implications of changes to ISO 13485, and how they will affect your company
- Regulators’ approach to the ISO 13485:2003 requirements
- Explanation of the risk management (ISO 14971) requirements
- Interpretation and Application of ISO 13845:2003 Quality Management Standards
- Development of Business Process approach to Quality Management System
- Preparation and documentation of Quality Management Manuals, Procedures and Work Instructions
- Overview of Audits and Assessment Techniques
- Implementing a Quality Management System
- Achieving Third Party Certification and Maintaining a Quality Management System
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