Development of a model for integrate risk management into the quality management system in a public laboratory

Abstract

The integration of risk management into quality management, a major challenge for public laboratories, will bring even more reliability to the results issued, enhancing opportunities and minimizing risks to public health. The proposed systematics was applied as a case study to the trial to determine the potency of the hepatitis B vaccine, carried out at INCQS, which has ABNT NBR ISO/IEC 17025 as the basis of its quality management system and follows follows the Management guidelines of the Federal Accounting Court (TCU) and Office of the Federal Controller General (CGU), the Fiocruz Risk Management Guide and ABNT NBR ISO 31000. The main result was the elaboration of a work process with a description of steps and techniques, which allow risk management to be integrated with quality management, adding benefits to ensure the reliability of analytical results bringing benefits to the citizens.