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CLSI M50 A : 1ED 2008

Current
Current

The latest, up-to-date edition.

QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-08-2008

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.

DevelopmentNote
Supersedes NCCLS M50 P. (09/2008)
DocumentType
Standard
ISBN
1-56238-675-1
Pages
40
PublisherName
Clinical Laboratory Standards Institute
Status
Current
SupersededBy
Supersedes

CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
CLSI M52 : 1ED 2015 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition

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