Our publication has described the method, courses and practical application of the quality management system according to standard ISO 9001:2000 at the Department of Clinical Biochemistry and Hematology, University Hospital Brno. Individual phases of implementation of all elements of the quality system are described. 1. Comparison of the existing management system, its effectivness, level of documentation, records and methods of internal as well as external communication with requirements of each element of the standard. 2. Determination of the time programme of establishment, review, authorization and implementation of documents of the IIIrd level (standard operating analytical, technical, logistic procedure), the IInd level (directives), the Ist level (quality manual). The promulgation of quality policy and quality objectives. 3. Documentation of quality management system 4. Nomination of key persons for the implementation of quality management system, determination of their responsibilities and authorities (quality manager, administrator of documentation, metrologist), nomination of a quality council of the department. 5. Nomination and special training of internal auditors. 6. Idenitification of specificities of a department for the possibility of effective introduction of quality management system with respect to: – securing the optimal course of the fundamental process, – creating the environment enabling the fundamental process, – method of visualizing the fundamental and supporting processe the enable to realize the quality system project, – realizing the activities for continual improvement. 7. Documents of quality management system in clinical biochemistry and their link-up to individual items of standard ISO 9001:2000. 8. Development diagram of reciprocal relationship and action of elements and processe of quality management system.

        Key words: quality management system, control of documents, clinical biochemistry, ISO 9001:2000.