Quality system based on the standard SFS-EN ISO 9002 in Kuopio University Hospital.

Kuopio University Hospital, situated within middle-east Finland, adopted the ISO 9002 standard as its quality system and gained formal certification in March 1999. The rationale behind the decision to adopt ISO 9002 is given, along with the main elements of the journey. The experiences of the hospital, including the advantages and disadvantages, are explained. In particular, issues regarding the documentation process, control and calibration of 4,000 pieces of medical equipment and the impact on staffing levels for in-house trained personnel to undertake the audits are described. The impact on the service to date, including benefits and drawbacks, is covered, along with aspirations for the future. Kuopio Hospitals adopted some techniques during the implementation process which did not work as successfully as others. The article therefore includes these in an effort to pass on the learning acquired from implementing ISO 9002 within such a large hospital as Kuopio University Hospital.