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Quality system based on the standard SFS-EN ISO 9002 in Kuopio University Hospital
1Kuopio University Hospital, Kuopio, Finland.
Summary
Kuopio University Hospital implemented the ISO 9002 quality standard, detailing the process, challenges with medical equipment calibration and staffing, and overall service impact. This case study shares valuable lessons for large hospital quality system adoption.
Area of Science:
- Healthcare Management
- Quality Management Systems
Background:
- Kuopio University Hospital in Finland adopted the ISO 9002 standard for its quality system.
- Formal certification was achieved in March 1999.
Purpose of the Study:
- To outline the rationale and key elements of adopting the ISO 9002 standard.
- To share experiences, including advantages and disadvantages, encountered during implementation.
- To provide learning insights from the ISO 9002 implementation in a large hospital setting.
Main Methods:
- Adoption of the ISO 9002 quality system standard.
- Detailed documentation processes.
- Control and calibration of approximately 4,000 medical equipment units.
- Assessment of impact on staffing levels for internal audits.
Main Results:
- Successful formal certification achieved in March 1999.
- Identified challenges in documentation, medical equipment management, and staffing.
- Observed both benefits and drawbacks in service impact.
- Some implemented techniques were less successful than others.
Conclusions:
- The implementation of ISO 9002 in a large hospital presents unique challenges and benefits.
- Sharing practical experiences, including unsuccessful methods, is crucial for future quality system implementations.
- The hospital gained valuable learning from the ISO 9002 journey.