Quality & Standards - Lecture 6: Continual Improvement in ISO 13485 - 24 slides
Explore Lecture 6: Continual Improvement in ISO 13485, covering This lecture focuses on the concept of continual improvement in ISO 13485, highlighting its importance for enhancing.
Topics Covered
Introduction to ISO 13485 and Continual Improvement
Understanding Continual Improvement in Quality Management
Importance of Continual Improvement in ISO 13485
Key Principles of Continual Improvement
Definition and Importance of Corrective Actions
Steps in Implementing Corrective Actions
Case Study: Successful Corrective Action Implementation
Preventive Measures in ISO 13485
Engaging Employees in Improvement Initiatives
Training and Development for Continuous Improvement
Tools and Techniques for Continuous Improvement
Lean Principles in ISO 13485
Overcoming Resistance to Change
Success Stories in Continuous Improvement
Data Analysis in ISO 13485
Types of Data Used in Quality Management
Collecting Data for Continual Improvement
Analyzing Data for Insights
Six Sigma Methodology in Quality Management
The PDCA Cycle in Continual Improvement
Benchmarking for Best Practices
Linking Customer Feedback to Improvement
Summary of Continual Improvement in ISO 13485
Conclusion and Key Takeaways
References
ISO (2016) ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes. Geneva: ISO.
Deming, W.E. (1986) Out of the Crisis. Cambridge: MIT Press.
ISO (2016) ISO 13485:2016 Guidance Document. Geneva: ISO.
ISO (2016) ISO 13485:2016. International Organization for Standardization.
Anderson, D. and Fagerhaug, T. (2002) Root Cause Analysis: Simplified Tools and Techniques.
ISO (2016) ISO 14971: Application of Risk Management to Medical Devices.
Deming, W. Edwards (1986) Out of the Crisis. Cambridge, MA: MIT Press.
Juran, Joseph M. (1992) Juran on Quality by Design. New York: Free Press.
Ishikawa, K. (1985) What Is Total Quality Control? Englewood Cliffs, NJ: Prentice-Hall.
Womack, James P., and Jones, Daniel T. (2003) Lean Thinking. London: Free Press.
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Atlas Medical Innovations 2023 - Continuous Impact Story Insights
ISO (2016) ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes.
Juran, J.M. and Gryna, F.M. (1988) Juran's Quality Control Handbook.
ISO (2016) ISO 13485 Commentary.
Deming, W.E. (1986) Out of the Crisis.
ISO (2016) ISO 13485: Medical devices – Quality management systems.
Munro, R. (2008) Lean Six Sigma for Medical Device Manufacturing.
Deming, W.E. (1986) Statistical Adjustment of Data.
Juran, J.M. (1989) Juran on Leadership for Quality.
Pyzdek, T. and Keller, P. (2012) The Six Sigma Handbook. 4th edn. New York: McGraw-Hill.
Deming, W.E. (1986) Out of the Crisis. Cambridge, MA: MIT Press.
Camp, R.C. (1989) Benchmarking: The Search for Industry Best Practices That Lead to Superior Performance. Milwaukee, WI: Quality Press.
ISO (2016) ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes. Geneva: ISO 13485.
Goetsch, D.L. and Davis, S.B. (2016) Quality Management for Organizational Excellence. 8th edn. Pearson.
Oakland, J.S. (2011) Total Quality Management and Operational Excellence. 4th edn. Abingdon: Routledge.