Quality Management Systems & Quality Assurance

Who this is for

• Medical laboratory scientists
• Biomedical scientists
• Clinical research associates and site staff
• Quality officers in health and pharmaceutical organisations
• Regulatory and compliance staff

What you will be able to do

• Design and document a quality management system for your organisation
• Run process control, occurrence management and document control
• Define and measure quality indicators such as turnaround time
• Prepare a laboratory or research site for external assessment
• Use systems thinking and data when making operational decisions

Curriculum

1. 01

   Foundations of quality management

   Quality concepts, the cost of poor quality, and how a quality system differs from quality control.

2. 02

   Documentation and document control

   Building the document hierarchy: policies, processes, procedures and records, and keeping them controlled.

3. 03

   Process control and occurrence management

   Identifying, recording and closing out non-conformities, and preventing recurrence.

4. 04

   Quality indicators and measurement

   Choosing indicators that matter, collecting the data, and using it to drive improvement.

5. 05

   Internal audit

   Planning, conducting and reporting an internal audit against a standard.

6. 06

   Continual improvement

   Management review, corrective and preventive action, and embedding improvement in daily work.

Entry requirements

• A degree or diploma in a health, laboratory or life sciences discipline, or equivalent professional experience