SULM – Schweizerische Union für Labormedizin | Union Suisse de Médecine de Laboratoire | Swiss Union of Laboratory Medicine

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1University Hospital Merkur, Institute of Clinical Chemistry, Zagreb, Croatia, 2University Hospital Merkur, Department of Surgery, Zagreb, Croatia

Objective. There is increasing need in medical biochemical laboratories for control of complete laboratory process through implementation of total quality management system based on international quality requirements. This project was aimed to achive a coherent quality system able to document all laboratory activities including not only the internal quality control and external quality assessment schemes but also policy, procedures, laboratory methods, organisation structures, tasks and responsibilities.
Methods. The introduction of the quality management system in the Institute of Clinical Chemistry was based on the general standard for quality management EN ISO 9001:2000 and the Croatian national Guide for quality management in medical biochemical laboratories with corresponding quality manual issued by Croatian Chamber of Medical Biochemists.
Results. In 2003 the Institute of Clinical Chemistry, University Hospital Merkur, Zagreb was the first routine medical biochemical laboratory in Croatia which introduced Quality Management with certification of the laboratory Quality System according to ISO International standard 9001:2000. Implementation of this standard in the developing of quality management system has created the awareness of quality as a leading issue in the all aspects of laboratory activities as well as in the daily work routines. The next goal is to establish international criteria according to the new ISO 15189 standard specific to medical laboratories which harmonises the existing general standard ISO 9001:2000 and quality management for laboratories ISO/IEC 17025 and represents the basis for accreditation.
Conclusion. Certification according to ISO 9001:2000 standard in the development of quality management system approves the ability of the Institute of Clinical Chemistry to provide measurements which objectively reveal the functional status of the patient and offers the possibilities of recognizing its high professional competence.


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