Laboratory accreditation standards

Abstract

The role of a medical molecular microbiology laboratory is to consistently produce reliable and meaningful clinical data, essential for both health assessment and disease control. This role defines the standard for quality. Quality is the result of planned and monitored activity. It requires the setting of goals and the monitoring and analysis of processes and procedures to ensure the required outcome is reliably and repeatedly attained. This includes the need to consider how quality is attained when the laboratory produces its assays in-house. The importance of activities to ensure ongoing quality must be acknowledged and supported appropriately from the highest levels of management. For Australian medical molecular microbiology laboratories, the decision to achieve and maintain quality is not optional, it is mandated. © 2010 Springer Science+Business Media B.V.