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ISO 9000 model ideally suited for quality plan at blood centers
N D Kalmin1, L K Myers, M B Fisk
1South Texas Blood and Tissue Center, San Antonio 78201, USA.
Transfusion
|March 3, 1998
Summary
Implementing the International Organization for Standardization (ISO) 9002 model successfully established a superior quality plan for a blood center. This quality management system ensures consistent operations and meets regulatory requirements.
Area of Science:
- Quality Management Systems
- Biotechnology
- Healthcare Administration
Context:
- Organizations in manufacturing, trade, and services require robust quality plans.
- The International Organization for Standardization (ISO) provides global standards for quality management.
- Blood centers are critical institutions that necessitate structured quality assurance.
Purpose:
- To implement a superior quality plan for a blood center using the ISO 9002 conformance model.
- To guide a core management team through the process of establishing a comprehensive quality system.
- To address and rectify weaknesses in existing quality and document systems.
Summary:
- A gap analysis using a 20-element ISO assessment audit identified areas for improvement.
- The ISO 9002 model guided the development and implementation of enhanced standard operating procedures across all departments.
- Progress was monitored by a registrar and an outside facilitator, ensuring adherence to the quality plan.
Impact:
- Full implementation of ISO principles was achieved within the project timeline.
- Consistent quality was ensured throughout the blood center via updated procedures and improved management practices.
- The established quality plan meets the requirements set by the American Association of Blood Banks.