ISO 9000 model ideally suited for quality plan at blood centers.

摘要

BACKGROUND: The development of a quality plan is essential for organizations involved in manufacturing, trade, and services. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade, and communications standards that are applicable worldwide and that provide the basis of a quality plan for institutions such as blood centers. STUDY DESIGN AND METHODS: The ISO 9002 conformance model and a registrar were selected to guide a core management team in establishing a superior quality plan for a blood center. The initial phase required that an analysis of the existing quality and document systems be performed, utilizing a 20-element "status of readiness" ISO assessment audit (gap analysis). Weaknesses in the quality systems were targeted and progress was evaluated by the registrar and an outside facilitator. RESULTS: Full implementation of ISO principles was achieved within the established timeline. Standard operating procedures were reviewed, supplemented, and expanded in every department, thereby ensuring consistent quality throughout the organization. Improvements in management, training, inspections, and statistical reporting were soon apparent during regular departmental audits. CONCLUSION: The ISO 9000 model is ideally suited for use by blood centers to establish a quality plan as required by the American Association of Blood Banks.