CLSI I/LA33 P : 1ED 2009

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION

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Superseded date: 30-12-2009

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Published date: 12-01-2013

Publisher: Clinical Laboratory Standards Institute

Table of Contents - (Show below) - (Hide below)

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
The Quality Management System Approach
Related CLSI Reference Materials

Abstract - (Show below) - (Hide below)

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

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Document Type	Proposed Guideline
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Superseded
Superseded By	CLSI I/LA33 A : 1ED 2009

Standards Referenced By This Book - (Show below) - (Hide below)

BIS IS/ISO 15189 : 2012	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
I.S. EN ISO 15189:2012	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
PREN ISO 15189 : DRAFT 2011	MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
UNE-EN ISO 15189:2013	Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNI EN ISO 15189 : 2013	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
11/30173018 DC : 0	BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012	Medical laboratories. Requirements for quality and competence

Standards Referencing This Book - (Show below) - (Hide below)

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 EP18 P3 : 3ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
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

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