Standards for quality management on Clinical analysis laboratories

摘要

Clinical analysis laboratories in Brazil, due to a new regulation, are required to implement indicators from the Qualiss Program - a quality management system regulated by the government. Interviews with experts in the field suggest that standards as ISO 9001, ISO 17025 and ISO 15189 must be followed in these processes of quality system implementation. A literature review did not find a study that provides a critical analysis of these standards. The contribution of this paper is to provide the main differences and similarities among these standards. The objective is to understand how they complement themselves and find out how much as one overlaps each other. Results show that a company with ISO 9001 certification do not attend requirements for the ISO 17025 and ISO 15189 certifications. According to the interviewed experts, ISO 9001 is the favorite one for implementation is this type of companies in Brazil and its requirements also attend the Qualiss Program standards.