Development of a pan-European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood.
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Working Group 1
Working Group 2
Working Group 3
Working Group 4
Work Process
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Blood Manual Ordering
Members Area
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 2007)
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
EU-Q-Blood Survey