[The Establishment and Reality of a Quality Management System--Chairmen's Introductory Remarks]

Compared with clinical test data, the main ditterence from other forms of medical information is the objectivity of clinical test data. The value of clinical testing is basically to offer objective and reliable clinical test data for clinical practice both timely and promptly. A quality management system supports those practices, and the mission of a clinical test department is to embody the principle of accuracy assurance and reflect it in routine clinical testing. Accuracy management was previously a system to maintain and manage accurate reading, but it has developed into a system to assure data quality. It is considered necessary to use knowledge and skills on accuracy assurance and actively ensure the reliability of data. We therefore suggest the need for "a shift from accuracy assurance to quality management".