Introduction of new international requirements for medical laboratory through comparison of ISO 15189∶2012 and ISO 15189 ∶2007 / 中华检验医学杂志

ABSTRACT

ISO 15189:2012Medical 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.