CLSI I/LA33 P : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION
30-12-2009
12-01-2013
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
Specifies guidance to the end user and laboratory for validation of automated systems used in immunohematologic testing prior to implementation.
| DocumentType |
Proposed Guideline
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| 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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