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Quality management systems, Six sigma philosophy, basic statistical quality control, tools for quality improvement, process capability analysis, Kaizen, quality costs, quality auditing, Quality in a regulated sector e.g. Medical Devices.
Learning Outcomes 1. State the elements and documentation requirements, and be able to develop a quality management system. 2. State the Six Sigma philosophy and how it is applied in a business. 3. Design Statistical Quality Control charts for attributes and variables and develop a quality improvement programme. 4. Appreciate the role of audit programs and benchmarking. 5. State the quality system requirements of a regulated manufacturing environment such as medical device manufacturing e.g. ISO13485 or FDA QSRs. 6. Develop a quality cost management program. 7. Familiarity with the requirements of ISO9001. 8. Use the basic tools of quality management.