Experience in Implementing ISO 15189:2012 Accreditation at Chimera Transplant Research Foundation: A Molecular Testing Laboratory

Abstract

ISO15189:2012 is a formal recognition by an authorized national accreditation body that a testing laboratory is competent to carry out specific tasks according to the standard. This article aims to share the experience of reaching ISO 15189:2012 accreditation at Chimera labs. A gap analysis was performed, followed by the preparation and implementation of policies and procedures for the effective implementation of QMS. After six months of intensive work, including mentoring activities, the laboratory was ISO 15189 accredited in the field of medical genetics and related HLA and immunogenetics by the National Accreditation Board for Testing and Calibration Laboratories, India. Our experience suggests that the implementation of a quality management system is possible even in small-sized laboratories with the help of skilled manpower and supportive management.