CAJ | 학술논문

ISO 15189:2012《医学实验室质量和能力的要求》于2012年11月1日发布,替代ISO15189:2007《医学实验室质量和能力的专用要求》.研究新旧标准的变化,有利于医学实验室、监管机构、认可机构各方了解和理解新的国际要求,不断改进实验室的管理,以持续符合国际标准要求.本文深入分析新标准内容的重要变化,以帮助各方正确理解并更加有效地应用新标准,从而满足实验室建设、管理、认可等的新要求.
ISO 15189:2012《의학실험실질량화능력적요구》우2012년11월1일발포,체대ISO15189:2007《의학실험실질량화능력적전용요구》.연구신구표준적변화,유리우의학실험실、감관궤구、인가궤구각방료해화리해신적국제요구,불단개진실험실적관리,이지속부합국제표준요구.본문심입분석신표준내용적중요변화,이방조각방정학리해병경가유효지응용신표준,종이만족실험실건설、관리、인가등적신요구.
ISO 15189:2012 " Medical laboratories-Requirements for quality and competence" was issued on November 1,2012,which replaced the second edition (ISO 15189:2007 "Medical laboratoriesParticular requirements for quality and competence").A study on changes in new edition standard will facilitate medical laboratories,regulatory authorities,accreditation bodies to have a good understanding of requirements of this new edition.An implementation of new edition will assist medical laboratory to improve their management to continually meet requirements of international standards.To enable stakeholders mentioned above have a good understanding and application of this new edition,changes in new edition were discussed in depth in this article.