Quality management system of regional and general hospital medical laboratory in relation to ISO 15189:2007, Thailand
The objectives of this study were to assess the quality management system of 95 medical laboratories at regional and general hospitals under the jurisdiction of the office of the permanent secretary, Ministry of Public Health, Thailand, in relation to ISO 15189:2007 and determine the relationships between role perception, leadership and organization climate with medical laboratory quality management. This study was a cross-sectional study. Data were collected by self-assessment questionnaire distributed to 95 medical laboratory unit chiefs from August 2008 to January 2009. The response rate was 100%. Statistical analysis used were Pearsons product moment correlation coefficient and stepwise multiple regression. Results revealed that role perception, leadership and organization climate were significantly related to overall quality management of ISO 15189:2007 (p<0.001). Leadership of the medical laboratory unit chiefs and organization climate were the variables that could explain the quality management of ISO 15189:2007 at 17.1% (R2adj 0.171). It is recommended that medical laboratory unit chiefs should enhance their leadership and be responsible for design, implementation, maintenance and improvement of the quality management. Top management should ensure that the organization structure, organization policy, surrounding and technology which contribute to a quality management system have been made in relation to requirements of ISO 15189:2007.