CLSI M50 A : 1ED 2008

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

This document provides quality control (QC) information for commercially available microbial identification systems (MISs), which are test systems that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeast-like algae (eg, Prototheca species) grown
from culture.