Recent development of the medical laboratory accreditation in China and the related international standards

Medical laboratory accreditation with ISO 15189 has brought up concerns from various interest parties in China. It is a common concern for both Accreditation Body (AB) and Medical Laboratory (ML) on how to ensure and improve the accreditation work scientifically and effectively. It will help us to find a way to solve the problem and to find the right way for the development of the medical laboratory accreditation if we study the drafting, implementation and apphcation of the international standards which found the basis of the accreditation scheme. This article will give the reader a brief introduction of the ISO/ TC212, which is the technical committee of international standard organization responsible for drafting and revising ISO 15189, medical laboratory accreditation related international standard documents, and the recent status and the future development of the medical laboratory accreditation in China. We hope this article can give some information for the medical laboratory stuffs and the professionals in laboratory medicine on their research work of the technique and the trend of development in medical laboratory management and medical laboratory accreditation. Key words: Clinical laboratory techniques; Reference standards; Total quality management