Medical Device Quality Management Systems Strategy and Techniques for Improving Efficiency and Effectiveness
Auteur : Manz Susanne
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 System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.
Part 1: An Effective Quality System1. Regulatory requirements 2. Increasing Expectations3. Establish and Maintain4. QMS Structure
Part 2: An Efficient Quality Management System5. Shifting from Cost of Quality to Value of Quality6. Avoiding Common mistakes
Part 3: Roles, Responsibilities, Capabilities7. Quality is Not an Organization8. Roles: Management Representative9. Management with Executive Responsibility10. Process Ownership11. Capabilities:Measure – Metrics and DashboardsEmbrace- Culture and ValueIdentify – Inspection, Audit, Process Control, etc.Fix – CAPA, Six Sigma, and morePrioritize – Risk Management, Residual RiskControl – Monitor and ControlShare and Communicate – Management Review and Transparency
Part 4: Quality Leadership and a Seat at the Table12. Value of Quality13. Maturity Modeling in Medical Device Companies
Part 5: Vision, Strategy, Quality Planning14. Compelling Vision15. Alignment16. Translating vision to plans
Part 6: Improvement: Tools and Techniques17. CAPA18. Six Sigma
- Provides practical, real-world guidance on developing an effective and efficient Quality Management System
- Presents a roadmap for QMS development
- Covers techniques to assess current state
- Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
Date de parution : 10-2018
Ouvrage de 294 p.
19x23.3 cm
Thèmes de Medical Device Quality Management Systems :
Mots-clés :
483 response; 5 Whys; 5 whys; 5S; 5Whys; A3; AAMI; ANOVA; Acquisition; Acquisition mode; Action plans; Added value; Adequate resources; Adulterated; Advamed; Advertising; Affirmative responsibility; Alignment; Analyze; And prove it; implement; Annotate 483; Appraisal cost; Appropriate; Assessor; Authority; Automation; Back room; Backroom leader; Barriers to quality; Behavior; Big Q; Business situation; CAPA; CAPA and improvement; CAPA records; CMMI; CTQ tree; Capabilities; Capability; Case for q