CLSI EP18-P2

Risk Management Techniques to Identify and Control Laboratory Error Sources; Proposed Guideline - Second Edition

Clinical and Laboratory Standards Institute document EP18-P2 - Risk Management Techniques to Identify and Control Laboratory Error Sources; Proposed Guideline - Second Edition recommends a quality management system for in vitro diagnostic test systems that is based on expert opinion, is practical to implement, and is applicable to various devices and settings, so sources of error (potential failure modes) are identified, understood, and managed. This system will assist device manufacturers, users, regulators, and accrediting agencies in assuring correct results. It addresses regulatory considerations (eg, principles and accountability), recommends the development of a partnership between users and manufacturers, provides a source-of-errors matrix, and suggests approaches to quality monitoring/identification of the problems.