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CLSI
CLSI EP18 A2 : 2ED 2009

CLSI EP18 A2 : 2ED 2009

Current

Current

The latest, up-to-date edition.

RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2009

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 User-Manufacture Quality Partnership
6 FMEA/FTA, and FRACAS
References
Explanation of the Appendixes
Appendix A - Example of a "System-Specific Sources of Failure"
             Matrix - an FMEA
Appendix B - An Example of a Manufacture's FMEA
Appendix C - Laboratory FMEA: Manufacturer-Completed Part and
             Clinical Laboratory-Completed Part
Appendix D - Example of a FRACAS
Appendix E - A Note on Unit-Use Devices
Summary of Comments an Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Specifies risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results.

DevelopmentNote
Supersedes NCCLS EP18 P3. (12/2009)
DocumentType
Standard
ISBN
1-56238-712-X
Pages
94
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

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Hardcopy - English
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