CLSI M50 P : 1ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
08-29-2008
01-12-2013
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
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