CLSI M52 : 1ED 2015

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Requirements for Implementation of
            Commercial Test System
Chapter 3 - The Microbial Identification System and
            Antimicrobial Susceptibility Testing System
            Verification Process
Chapter 4 - Post verification Quality Assurance for Microbial
            Identification and Antimicrobial Susceptibility
            Testing System
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Appendix A - Regulatory Requirements for US Food
             and Drug Administration Clearance of
             Commercial Devices and International Organization
             for Standardization Certification of Device
             Manufactures
Appendix B - Verification Testing of Revised CLSI
             Breakpoints
Appendix C - Examples of Verification Protocols
Appendix D - Verification Data Example for Microbial
             Identification Systems
Appendix E - CLSI Quality Control Strains That May Be
             Considered for Verification of Antimicrobial
             Susceptibility Testing System
Appendix F - Antimicrobial Susceptibility Testing System
             Verification Worksheets and Data Summary
             Examples
The Quality Management System Approach
Related CLSI References Materials

This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)–cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use in diagnostic testing.