In order to reduce the risk and maximize the benefits of the transplantation of human tissues, it is necessary to operate, an effective quality system. The key elements of a quality system could be the following:

a) Personnel and organization;

b) Premises, equipment and materials;

c) Documentation and its control;

d) Selection, procurement, testing and processing/handling;

e) Quality control and proficiency testing;

f) Traceability;

g) Complaints, errors and accidents, adverse events and recalls;

h) Self-assessment and internal and external audits;

i) Tissues and storage conditions;

j) Distribution;

k)Final labeling for distribution;

l) External labelling of the shipping container.

Do we need to add any new element to the above list?