[Usefulness of the authorized acquisition of ISO 15189 in registered clinical laboratories].

More than 10 years have passed since the ISO 15189 international standardization program on the quality and competence of the medical laboratories was introduced in 2003. Currently, the number of facilities that have committed themselves to providing a higher level of medical service by incorporating a quality management system (QMS) and acquiring accreditation has grown to over 70. QMS is defined as "setting up a policy and goals pertaining to quality, and adopting an appropriate system," and is a scheme that includes all factors both managerial and technical that can affect test results. A number of registered clinical laboratories have received the aforementioned accreditation, but, in the process of implementing the QMS, some problems have been identified. Here, we report on the change (transition) of Quality Control to Quality Management System, the usefulness of external audits by the official inspection body for accreditation, and the problems that I have encountered over the last ten years.