This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.

Cross References:
ISO/IEC Guide 63:2012
IEC/ISO 31010:2009
ISO/IEC Guide 51:1999
ISO/TR 24971:2019
ISO 18113:2009
ISO/TS 22367:2008
ISO/IEC Guide 99:2007
ISO Guide 73:2009
IEC 62366-1:2015/COR1:2016
IEC 60601-1:2005/COR1:2006
ISO 13485:2016
ISO 31000:2009
ISO 20916:2019
IEC 60812:2006
ISO 15190:2003
IEC 60601-1:2005/COR2:2007
ISO 31000:2009 (F)
IEC 61025:2006
ISO 15189:2012
ISO 9000:2015 Advanced Access
IEC 60601-1:2005/AMD1:2012/COR1:2014
ISO 14971:2019
ISO 9000:2015


All current amendments available at time of purchase are included with the purchase of this document.