ISO 9000 case study: the role of the external consultant

BACKGROUND: Increasingly, blood centers worldwide are turning toward the ISO (International Organization for Standardization) 9000 Quality System Standards to meet regulatory demands of public authorities, competitive demands within their industry, and cost requirements from their customers. CASE REPORT: The South Texas Blood and Tissue Center is the first blood center in North America to achieve registration to the ISO 9002 Quality System Standards. The role of the external consultant in initiating the process and as a facilitator during the implementation process is examined. CONCLUSION: To ensure the long‐term success and viability of any quality system, it is necessary for an organization to develop and implement its own program. External consultants can assist in many ways, but it is important that their role be a supporting one rather than one of direct implementation.