CLSI EP18

Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition

This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes.

This document is available in electronic format only.

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Chairholder: Jan S. Krouwer, PhD

Date of Publication: November 30, 2009

Order Code PDF: CLSI EP18A2E
ISBN Number: 1-56238-712-X

Order Code Print: print not available

Edition: Second

Pages: 94

CLSI EP18 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of August 2020. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI EP18 Abstract

Clinical and Laboratory Standards Institute document EP18-A2—Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved 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 failure (potential failure modes) are identified, understood, and managed. This system will assist device manufacturers, regulators, accrediting agencies, and laboratory directors in ensuring correct results. It addresses regulatory considerations (eg, principles and accountability), recommends the development of a partnership between users and manufacturers, provides a source-of-failures matrix, and suggests approaches to quality monitoring/identification of the problems.