CLSI I/LA33 A : 1ED 2009

Name: CLSI I/LA33 A : 1ED 2009
Brand: CLSI

Withdrawn

VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION

Withdrawn date

03-28-2016

Published date

01-12-2013

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Immunohematology Tests and Automated Systems
5 Validation Process
6 Materials (Reagents, Equipment, and Supplies)
7 Installation Qualification
8 Operational Qualification
9 Performance Qualification
References
Appendix - Sample Templates and Test Cases
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidance to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation.

DevelopmentNote	Supersedes NCCLS I/LA33 P. (04/2010)
DocumentType	Miscellaneous Product
PublisherName	Clinical Laboratory Standards Institute
Status	Withdrawn
Supersedes	CLSI I/LA33 P : 1ED 2009

DIN EN ISO 15189:2014-11

Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

CLSI EP14 A2 : 2ED 2005	EVALUATION OF MATRIX EFFECTS
CLSI H57 A : 1ED 2008	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
CLSI M29 A3 : 3ED 2005	ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI EP7 A2 : 2ED 2005	INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI AUTO8 A : 1ED 2006	MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
CLSI QMS03 A3 : 3ED 2009	TRAINING AND COMPETENCE ASSESSMENT
CLSI GP2 A5 : 5ED 2006	LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
CLSI EP18 A2 : 2ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES