Quality Systems

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.