ISO-9000 MODEL IDEALLY SUITED FOR QUALITY PLAN AT BLOOD CENTERS

BACKGROUND: The development of a quality plan is essential for organiz ations involved in manufacturing, trade, and services. The Internation al Organization for Standardization (ISO) has established a common set of manufacturing, trade, and communications standards that are applic able worldwide and that provide the basis of a quality plan for instit utions such as blood centers. STUDY DESIGN AND METHODS: The ISO 9002 c onformance model and a registrar were selected to guide a core managem ent team in establishing a superior quality plan for a blood center. T he initial phase required that an analysis of the existing quality and document systems be performed, utilizing a 20-element ''status of rea diness'' ISO assessment audit (gap analysis). Weaknesses in the qualit y systems were targeted and progress was evaluated by the registrar an d an outside facilitator. RESULTS: Full implementation of ISO principl es was achieved within the established timeline. Standard operating pr ocedures were reviewed, supplemented, and expanded in every department , thereby ensuring consistent quality throughout the organization. Imp rovements in management, training, inspections, and statistical report ing were soon apparent during regular departmental audits. CONCLUSION: The ISO 9000 model is ideally suited for use by blood centers to esta blish a quality plan as required by the American Association of Blood Banks.