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ISO 9000 case study: the role of the external consultant
1Abbott Quality Institute, Abbott Laboratories, Abbott Park, Illinois 60064, USA.
Transfusion
|March 3, 1998
Summary
Blood centers are adopting International Organization for Standardization (ISO) 9000 standards for quality management. This case study highlights the importance of internal program development for sustained success, with consultants playing a supporting role.
Area of Science:
- Quality Management Systems
- Healthcare Administration
- Blood Banking Operations
Background:
- Global blood centers increasingly adopt International Organization for Standardization (ISO) 9000 Quality System Standards.
- Drivers include regulatory compliance, industry competition, and customer cost demands.
Purpose of the Study:
- To examine the implementation of ISO 9002 Quality System Standards at a North American blood center.
- To evaluate the role of external consultants in the quality system registration process.
Main Methods:
- Case study of the South Texas Blood and Tissue Center's ISO 9002 registration.
- Analysis of the initiation and facilitation roles of an external consultant.
Main Results:
- The South Texas Blood and Tissue Center became the first in North America to achieve ISO 9002 registration.
- External consultants were instrumental in initiating and facilitating the quality system implementation.
Conclusions:
- Organizations must develop and implement their own quality systems for long-term success.
- External consultants should provide support, not direct implementation, for sustained viability.