title: [Challenges and solutions for laboratory operation and maintenance].
abstract: There are several kinds of medical laboratory accreditation scheme in Japan, such as ISO 15189, CAP, and JCI. The purpose of receiving a laboratory accreditation is not merely to receive the accreditation. It ensures Quality Management System (QMS) with technical competence as assessed by a third party. The most important point to establish and maintain QMS is not that it is driven by the accreditation scheme requirements, but that it advances them. The laboratory shall understand the philosophy of each requirement. These requirements are not cutting-edge; they are just ordinary for laboratory work. ISO 15189 was revised in 2012. Depending on this revision, ISO 15189 requirements may become more user-friendly. This is a chance to review and make up for the lack of QMS, and for the improvement of laboratory practices.
authors.forename: Masako
authors.initials: M
authors.lastname: Koguchi
mesh_terms: D064790:Clinical Laboratory Services / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000592:standards; D007564:Japan; D011785:Quality Assurance, Health Care; D017749:Total Quality Management