Work Process and Deliverables

EU-Q-Blood Survey

EU-Q-Blood Survey on Quality Management Systems implemented in the participating EU member, Applicant and EFTA countries Definition of areas of particular interest and risk in blood transfusion

EU-Q-SOP Framework Document

Framework document structure for Standard Operating Procedures (SOPs) following the EU legislative requirements set out by the Directive 2002/98/EC and its technical annexes

SOP Test

Writing of SOPs by participants of the working groups following selected topics defined in the area of interest and risk in order to test the framework document structure for Standard Operating Procedures (SOPs)

EU-Q-Blood-SOP Manual (Publication date 2008) advanced ordering form

EU-Q-Blood-SOP Manual to assist blood establishments to develop and implement their own SOPs containing

Background and Objectives
Requirements defined by 2002/98/EC

Overview of quality principles
linked to the Directive 2005/62/EC

SOP framework document structure
guidelines for document change control
guidelines for SOP training matrix concept

SOP Examples (WG1-4) covering the critical quality activities in the samples taken from the areas of interest and risk

References and Definition of
  • key quality terms linked to the Directive 2005/62/EC
  • GMP/GLP best practice terms used in the manual