The following documents support TML’s in developing their internal audit program under the Blood Regulations.
Registered – Internal audits are required to be performed every two years at minimum, on all regulated activities under the Blood Regulations. The audit intervals should be specified in hospital operating procedures.
Non-Registered – Internal audits are a component of TML’s quality management system, which include assessments of activities and processes it performs. Non-registered TML’s should conduct risk assessments to determine the frequency that audits to the processes which relate to regulated activities under the Blood Regulations.