CLSI M50 P : 1ED 2008

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 General Responsibilities of the Manufacturer, Distributor,
  and User
  5.1 Manufacturer
  5.2 The Distributor
  5.3 The User
6 Process for QC of MISs
  6.1 Manufacturer's Responsibilities
  6.2 User's Responsibilities to Qualify for Streamlined QC
7 QC Procedures for MISs
  7.1 QC Organisms
  7.2 QC Testing Process
  7.3 QC Testing Frequency
  7.4 Interpretation of QC Test Results
  7.5 Corrective Action
References
Appendix A - Manufacturer's Requirements for Streamlined QC
             Section of Package Insert or Product Information
             for an MIS
Appendix B - User's Requirements to Qualify for Streamlined
             QC of an MIS
Appendix C - Documentation of Streamlined QC Results - Minimum
             Record Requirements
Appendix D - Troubleshooting Guide for MIS QC Failures
The Quality Management System Approach
Related CLSI Reference Materials

Provides guidance for quality control of commercial systems for microbial identification from culture, including information that pertains to manufacturers, distributors, and laboratory users.