Division 1

There must be a system in place that results in clearly defined and effective documentation, correct records and registers and authorised Standard Operating Procedures (SOPs), for the activities for which accreditation/designation/authorisation/licensing is sought. Documents must be regularly reviewed and must conform to the standards laid down in this Directive. The system must ensure that work performed is standardised, and that all steps are traceable; i.e. coding, donor eligibility, procurement, processing, preservation, storage, transport, distribution or disposal, including aspects relating to quality control and quality assurance.