Quality management in European eye banks.

Background: The European Directive on setting standards of quality and safety for human tissues and cells obliges tissue establishments to implement a quality management system (QMS), based on the principles of good practice, in order to assure a high level of protection with regard to the health of recipients of human tissues.

Methods: A systematic approach to quality management should be used and sustained. Although a number of quality systems can be employed, a recommended reference model is the ISO 9001:2000 standard which is particularly relevant to eye banking as it can be implemented to cover the entire donation-transplantation process to ensure that the tissues distributed, and services offered, by eye banks show uniform safety and quality.

Results: The adoption and correct management of a QMS is essential to maximise the benefits and minimise the risks for all those involved in the process. The performance and results of this system must be monitored and measured by appropriate parameters/indicators (positive and negative) which pertain to the structure (personnel, facilities, instruments), the process (the sequence of activities), the outcome (recipient health status or client satisfaction), the efficiency (the costs incurred to produce a certain outcome) and the effectiveness (frequency that the required results are attained).

Conclusion: Careful attention must be paid to all aspects of the quality of donor tissues in order to maintain confidence in their safety and effectiveness. A well-managed QMS is a valuable and effective instrument to guarantee the required high standards for the donation, procurement, testing, processing, storage, distribution and traceability of ocular tissues as well as to facilitate the continuous improvement and the attainment of the objectives of an eye bank.