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Quality Systems
OVERVIEW
CEA CAPA Partner Institution: University of Galway
Location: Galway, Ireland
Primary Subject Area: Mechanical Engineering
Instruction in: English
Course Code: ME5102
Transcript Source: Partner Institution
Course Details: Level Graduate
Recommended Semester Credits: 2.5
Contact Hours: 36
DESCRIPTION
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.
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.
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