Essential elements include:

Leadership

• Management demonstrates commitment to quality
• Responsibility for quality is clearly assigned
• Resources are available
• There is an effective hospital transfusion committee or equivalent

Standards or specifications

• There are explicit statements of what a product should be or a process should achieve

Documentation

• There are written instructions for doing each job
• There are records to show whether the job has been done correctly

Change control

Changes in procedures are introduced in a controlled fashion and proper records are maintained

Evaluation or Audit

• Performance is independently assessed

Staff Training and Assessment

• Staff are taught what to do and why it is important
• Their knowledge and competence is assessed

Quality Improvement