European Communities (Quality System for Blood Establishments) Regulations 2006
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Communities (Quality System for Blood Establishments) Regulations 2006.
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paragraphs: These Regulations shall come into operation on 9 November, 2006.
Interpretation
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paragraphs: (1) In these Regulations-
‘computerised system’ means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation;
‘good practice’ means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations;
‘mobile site’ means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment;
‘processing’ means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component;
‘qualification’, as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results;
‘quality assurance’ means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use;
‘quality control’ means part of a quality system focused on fulfilling quality requirements;
‘quality management’ means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment;
‘quality system’ means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management;
‘quarantine’ means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents;
‘specification’ means a description of the criteria that must be fulfilled in order to achieve the required quality standard;
‘standard’ means the requirements that serve as the basis for comparison;
‘trace-back’ means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor;
‘validation’ means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled;
‘written procedures’ means controlled documents that describe how specified operations are to be carried out.
(2) A word or expression that is used in these Regulations and is also used in the Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 has, unless the contrary intention appears, the same meaning in these Regulations as it has in Directive 2002/98/EC.
Quality system standards and specifications
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paragraphs: Each blood establishment shall have a quality system in place which complies with the Community standards and specifications set out in the Schedule to these Regulations.
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paragraphs: Each blood establishment shall ensure that for blood and blood components imported from outside the European Community and intended for use or distribution in the Community, there is a quality system for blood establishments in the stages preceding importation equivalent to the quality system provided for in Regulation 4 hereof.
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paragraphs: The European Communities (Quality System for Blood Establishments) Regulations 2006 ( S.I. No. 552 of 2006 ) are revoked.