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The International Standard, ISO 15189 which specifies requirements for quality and competence in medical laboratories was written by medical laboratory professionals. Since its first publication in 2003, it has raised awareness of the importance of medical laboratories with governments throughout the world and provided a tool with which laboratories may develop their quality management systems and assess their own competence. This paper examines the use of the Standard in the context of self-assessment, accreditation and regulation of medical laboratories.

ISO standards for pathology – a step too far?