S.L. 483.1 Art. 11Quality management.

(1) Each tissue establishment shall put in place and update a quality system based on the principles of good practice.

(2) Such quality system shall include at least the following documentation:

(a) standard operating procedures,

(b) guidelines,

(c) training and reference manuals,

(d) reporting forms,

(e) donor records,

(f) information on the final destination of tissues or cells.

(3) The documentation referred to in sub-regualtion (2) shall be available for inspection by an authorised officer.

(4) Tissue establishments shall keep the data necessary to ensure traceability in accordance with regulation 4.