CLSI M50 A : 1ED 2008
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
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
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