To prepare the French Accreditation Committee (COFRAC) visit for initial certification of our medical laboratory, our direction evaluated its quality management system (QMS) and all its technical activities. This evaluation was performed owing an internal audit. This audit was outsourced. Auditors had an expertise in audit, a whole knowledge of biological standards and were independent. Several nonconformities were identified at that time, including a lack of control of several steps of the internal audit process. Hence, necessary corrective actions were taken in order to meet the requirements of standards, in particular, the formalization of all stages, from the audit program, to the implementation, review and follow-up of the corrective actions taken, and also the implementation of the resources needed to carry out audits in a pre-established timing. To ensure an optimum control of each step, the main concepts of risk management were applied: process approach, root cause analysis, effects and criticality analysis (FMECA). After a critical analysis of our practices, this methodology allowed us to define our "internal audit" process, then to formalize it and to follow it up, with a whole documentary system.
Keywords: ISO 15189 standard; corrective actions; process approach; quality management; risk analysis.