# Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) (Text with EEA relevance) (2010/453/EU), Division 5.1: Different types of inspection may be carried out:

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

(a) general system-oriented inspections should be on-site and cover all processes and activities, including: organisational structure, policies, responsibilities, quality management, personnel, documentation, data quality, systems for ensuring data protection and confidentiality, facilities, equipment, contracts, complaints and recalls or audits, information communication (within and across borders) and traceability of tissues and cells;
(b) thematic inspections should be on-site and cover one or more specific themes, e.g. quality management systems, preparation process, vigilance systems, or donor testing laboratory conditions;
(c) desk based reviews do not take place on-site but at a remote location and may cover all processes and activities or focus on one or more specific themes;
(d) reinspections may be indicated as follow-up or reassessment to monitor the corrective actions required during a previous inspection.

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Source: https://www.legislation.gov.uk/eudn/2010/453/annex/division/5/division/5.1 (the official version)
Page: https://openlegislation.uk/eu-decision-2010-453/annex/division-5/division-5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.