Plebani Mario
Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.
EJIFCC. 2004 Dec 28;15(4):136-140. eCollection 2004 Dec.
After a long-standing tradition of analytical quality and analytical quality control programs, most medical laboratories that are aware of the need for total quality management, are experiencing new systems designed to assure quality throughout the entire total testing process, from the pre-analytical to the post-analytical steps. The availability of a new International Standard, ISO 15189:2003, specifically developed and designed to satisfy the requirements for quality management and competence in medical laboratories, should promote the harmonization of accreditation programs at an international level, and implementation of an effective quality system at a local level. The importance of the pre- and post-analytical phases are well recognized in the new International Standard and, therefore, efforts to comply with this standard might assure an approach that safeguards and continuously improves total quality in medical laboratories.
在经历了长期的分析质量和分析质量控制程序传统之后，大多数意识到全面质量管理必要性的医学实验室，正在采用旨在确保从分析前到分析后整个总检测过程质量的新系统。专门为满足医学实验室质量管理和能力要求而制定的新国际标准ISO 15189:2003的出台，应能促进国际层面认可程序的协调统一，并推动地方层面有效质量体系的实施。新国际标准充分认识到分析前和分析后阶段的重要性，因此，努力遵守该标准可能确保一种保障并持续提高医学实验室全面质量的方法。
