CAJ | 학술논문

质量管理系统最初广泛用于临床检测实验室，近10年来才被逐步引入体外受精（IVF）实验室，对其实验方法及工作人员职责进行质量管理。作为辅助生殖技术中重要组成部分的IVF实验室，其环境会对胚胎的发育潜能产生影响，因此通过全面的质量管理系统为胚胎提供稳定的发育环境对IVF结局至关重要。实验室的质量控制手册应明确地告知工作人员哪些“必须做”、哪些“禁止做”，而且手册应不断更新，使操作程序内容更易于理解，实验操作方法更为灵活实用。因此，建立一个强有力的质量管理机制是拥有一个稳定IVF实验室的基础，是获得理想妊娠率的基础，是保证胚胎正常发育的基础。
질량관리계통최초엄범용우림상검측실험실，근10년래재피축보인입체외수정（IVF）실험실，대기실험방법급공작인원직책진행질량관리。작위보조생식기술중중요조성부분적IVF실험실，기배경회대배태적발육잠능산생영향，인차통과전면적질량관리계통위배태제공은정적발육배경대IVF결국지관중요。실험실적질량공제수책응명학지고지공작인원나사“필수주”、나사“금지주”，이차수책응불단경신，사조작정서내용경역우리해，실험조작방법경위령활실용。인차，건립일개강유력적질량관리궤제시옹유일개은정IVF실험실적기출，시획득이상임신솔적기출，시보증배태정상발육적기출。
The quality control (QC) system was initially been applied in the clinical testing laboratories. It has been introduced into in vitro fertilization (IVF) laboratory step by step in ten years. This system is helpful for QC of IVF methods and staff duties. IVF laboratory is important part of assisted reproduction technique (ART), because its environment is related to embryonic quality. It is therefore very important to provide embryo the stable culture environment in IVF laboratory by the QC system. The guideline of QC should declare what must be done and what must be prohibited. The Standard Operating Procedures(SOP) of QC system should be updated,so that it can be used smoothly in practice. It is necessary to develop the elaborated QC system for a steady IVF laboratory, which is also fundamental for the normal embryonic development and good clinical outcomes of ART.