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.

Learning Outcomes

  1. Critically evaluate quality management system models such as ISO 9001,  ISO 13485, EudraLex - Volume 4, 21CFR Part 820, 21CFR Part 211.

  2. Develop strategies for quality system management implementation and maintenance

  3. Evaluate Quality Management Systems against specified requirements 

  4. Determine the pathway to certification for ongoing registration and compliance with standards

  5. Prepare a site for third party audit from certification bodies, regulatory bodies, and customers

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