Part B: A description of the quality system, to include:

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.