# Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, Part B:: A description of the quality system, to include:

Extent: E+W+S+N.I.

documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships
documentation such as site master file or quality manual describing the quality system in accordance with Article 11(1)
number and qualifications of personnel
hygiene provisions
premises and equipment
list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood and blood components and for the reporting and recording of serious adverse reactions and events.

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Source: https://www.legislation.gov.uk/eudr/2002/98/annex/I/part/B (the official version)
Page: https://openlegislation.uk/eu-directive-2002-98/annex-I/part-B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.