Quality Systems

Web pages (click on title to navigate)

• Understanding the "Cold Chain" requirements
• Good Manufacturing Practice
• Self Inspection / Quality Audits
• Traceability
• Useful websites
• What does it mean to YOU?

• SLA - Technical Agreement for the Provision of Blood and Blood Components (doc)
• Method Validation Procedure (pdf)
• Process Validation in Blood Transfusion (pdf)
• EU implementation - Local Survey (pdf)
• Data logger specification (pdf)
• Validation:
  • BB Electronic Issue validation (pdf)
  • BB AutoVue LIS link validation (pdf)
  • BB AutoVue LIS link validation results sheet (xls)
  • BB AutoVue Serology validation (pdf)
  • Validation (OCD user group) (pdf)
• Standard Operating Procedures (SOP)
• Calibration (pdf)
• Change control (pdf)
• Quality audit (pdf)
• Recall (pdf)
• Transfer of components (pdf)
• SLA for the transportation of blood/blood components by taxi/courier
• Appendix 1 to the SLA for transporting blood/blood components
• User Requirement Specification (URS)
• Blood Bank
• Temperature Monitoring System