Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness /
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management...
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| Format: | eBook |
| Language: | English |
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London, United Kingdom :
Academic Press, an imprint of Elsevier,
[2019]
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| Online Access: | Connect to the full text of this electronic book |
Table of Contents:
- <P><b>Part 1: An Effective Quality System </b>1. Regulatory requirements 2. Increasing Expectations 3. Establish and Maintain 4. QMS Structure</p> <p><b>Part 2: An Efficient Quality Management System </b>5. Shifting from Cost of Quality to Value of Quality 6. Avoiding Common mistakes</p> <p><b>Part 3: Roles, Responsibilities, Capabilities </b>7. Quality is Not an Organization 8. Roles: Management Representative 9. Management with Executive Responsibility 10. Process Ownership 11. Capabilities: Measure
- Metrics and Dashboards Embrace- Culture and Value Identify
- Inspection, Audit, Process Control, etc. Fix
- CAPA, Six Sigma, and more Prioritize
- Risk Management, Residual Risk Control
- Monitor and Control Share and Communicate
- Management Review and Transparency</p> <p><b>Part 4: Quality Leadership and a Seat at the Table </b>12. Value of Quality 13. Maturity Modeling in Medical Device Companies</p> <p><b>Part 5: Vision, Strategy, Quality Planning </b>14. Compelling Vision 15. Alignment 16. Translating vision to plans</p> <p><b>Part 6: Improvement: Tools and Techniques </b>17. CAPA 18. Six Sigma</p>