scope:

This Technical Report provides guidance to medical laboratories describing how a medical laboratory can implement a quality system to meet the specific technical and management requirements for quality and competence in ISO 15189:2003. Bodies engaged in the recognition of the competence of medical laboratories may also be able to use this Technical Report as a basis to assist laboratories in establishing a quality system to meet national requirements, while at the same time conforming to appropriate International Standards. This guidance applies both to newly established and existing laboratories and encompasses both the management and technical requirements of ISO 15189:2003.