Quality and Regulatory Requirements for Industry

This module examines the international quality and regulatory standards that industry apply. ISO 9001 is a common business standard that general companies apply as a good business model and the ISO 13485 standard is specific to medical technology.  It is important that participants understand the application of these standards and the benefits they offer.  These are recognised world-wide and will allow students to engage with companies in a more meaningful and productive manner.

1. Understand the applicable regulations and/or standards that apply to various types of industry.

2. Apply the concepts of ISO 9001 for general Industry.

3. Apply the concepts of ISO 13485 for medical technology industry.

4. Explain the role and the application of the Quality Management System (QMS) in the overall business context.