Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness /

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Détails bibliographiques
Cote:Libro Electrónico
Auteur principal: Manz, Susanne (Auteur)
Format: Électronique eBook
Langue:Inglés
Publié: London, United Kingdom : Academic Press, an imprint of Elsevier, [2019]
Sujets:
Medical instruments and apparatus industry > Quality control.
M�edecine > Appareils et instruments > Industrie > Qualit�e > Contr�ole.
Medical instruments and apparatus industry > Quality control
Accès en ligne:Texto completo
Table des matières:
  • <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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