Abstract

ALVAREZ GUERRA, Sandra. Quality standards in clinical tests. ISO 9001: Good Clinical Practice. Rev Cubana Farm [online]. 2005, vol.39, n.3. ISSN 0034-7515.

The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were assessed. By means of these aspects, both standards contribute to the quality of clinical assays for a better protection of patients, reliable results, both external and domestic users´ satisfaction, ongoing improvement and setting of contingency plans and preventive measures. It was concluded that both standards are not opposite and may be used as a way of assuring excellence in rendered service.

Keywords : Good Clinical Practice; ISO 9001:2000.

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