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|a UAMI
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| 100 |
1 |
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|a Manz, Susanne,
|e author.
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| 245 |
1 |
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|a Medical device quality management systems :
|b strategy and techniques for improving efficiency and effectiveness /
|c Susanne Manz.
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| 264 |
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1 |
|a London, United Kingdom :
|b Academic Press, an imprint of Elsevier,
|c [2019]
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|a 1 online resource
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|a text
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|a Online resource; title from PDF title page (ScienceDirect, viewed October 15, 2018).
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|a <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>
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| 590 |
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|a Knovel
|b ACADEMIC - Biochemistry, Biology & Biotechnology
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| 650 |
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|a Medical instruments and apparatus industry
|x Quality control.
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| 650 |
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6 |
|a Médecine
|x Appareils et instruments
|x Industrie
|x Qualité
|x Contrôle.
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| 650 |
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|a Medical instruments and apparatus industry
|x Quality control
|2 fast
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| 856 |
4 |
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|u https://appknovel.uam.elogim.com/kn/resources/kpMDQMSST4/toc
|z Texto completo
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| 994 |
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|a 92
|b IZTAP
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