| The quality of blood products is crucial to the survival and health of the transfusion recipient. Therefore, it is imperative that blood centers use a quality system that is effective in producing safe, quality blood products.;There are three quality systems in use in the blood banking industry. The Food and Drug Administration (FDA) quality system is required by law. The others systems, American Association of Blood Banks (AABB) and International Organization for Standardization (ISO 9000) quality systems, are voluntary. This paper compares these quality systems to each other and to the needs of the blood banking industry.;The analysis shows that the FDA quality system is inadequate to ensure that only safe, quality products are distributed. The AABB and ISO 9000 quality systems provide a superior level of quality management. Of these voluntary quality systems, ISO 9000 provides a more complete and effective quality system than the AABB. |
