[Use of elements from the ISO 90000 system in Spanish hemotherapy]

To evaluate the prevalence of all twenty elements of ISO 9000 in the practice of the Blood Banks of Spain independently of being certified or not to ISO system.

By a survey sent in november 1996 to the Hospital-Based Blood Bank and Transfusional Services of 225 hospitals with more than 100 beds, and to 25 Community Blood Centers. The survey had 38 questions on the all elements of the ISO system and on other aspects of quality no directly related with it, as to be accredited by transfusional accreditation Committee, to have an hospital transfusion committee, informed consent of the transfusion and guidelines for using hemoderivatives.

The survey was answered by 53 (21%) of hospitals and Community Blood Centers. None of the participant were certified to ISO system. The elements more used were the documentation of adverse reactions, procedures manual, validation of blood components, control of nonconforming products, and product identification and traceability, all of them used for more than 80% of participants. On the contrary, the elements less used were to have a quality unit, equipment manual, to validate the computer system, internal quality audits, criteria on purchasing, training and quality manual, all of them used by less than 30% of the participants.

Generally speaking the elements of the ISO system more commonly used are those related to the basic ones of daily work and the least used are those related to the organisation aspects of quality. The Community Blood Centers score higher than hospital blood banks and among these, the best results are in the blood banks of hospitals more than 500 beds and the hospital accredited for teaching.