Quality Management Systems and Frameworks
The objective of this module is to ensure student understanding of quality standards, quality management systems and frameworks in order to be able to establish, implement and maintain an integrated approach to quality.
Critically evaluate quality management system models such as ISO 9001, ISO 13485, EudraLex - Volume 4, 21CFR Part 820, 21CFR Part 211.
Develop strategies for quality system management implementation and maintenance
Evaluate Quality Management Systems against specified requirements
Determine the pathway to certification for ongoing registration and compliance with standards
Prepare a site for third party audit from certification bodies, regulatory bodies, and customers