| Description |
1 online resource |
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text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| Note |
Online resource; title from PDF title page (ScienceDirect, viewed October 15, 2018). |
| 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> |
| Subject |
Medical instruments and apparatus industry -- Quality control.
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Médecine -- Appareils et instruments -- Industrie -- Qualité -- Contrôle.
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Medical instruments and apparatus industry -- Quality control
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| ISBN |
0128142219 |
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9780128142219 |
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9780128142226 (online) |
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0128142227 |
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9780128142219 |
| Standard No. |
AU@ 000064362693 |
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AU@ 000065067189 |
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AU@ 000065196146 |
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UKMGB 019075312 |
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