Applied Quality Management for the Clinical Diagnostic Laboratory

This is a professional and practice-based module. This module describes the ISO15189 quality standard requirements of medical laboratories. The module aims to develop an advanced awareness of the importance of quality in the delivery of healthcare excellence and explore approaches to continual improvement. The learner will gain knowledge of quality and how it applies to their role in the organisation. 

1. Critically evaluate the effect that routine laboratory operations have on quality patient care and healthcare excellence.  Exhibit an understanding of the process of managing and improving all aspects of quality in an organisation.

2. Perform internal audits, articulate and report non-conformances effectively including using the CAPA process.

3. Critically evaluate the importance and practices of key quality management processes such as documentation, auditing, CAPA, continual improvement and validation activities in an organisation.

4. Identify and apply the various quality management techniques in their own organisation.