CLSI EP23 A : 1ED 2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Quality Control Toolbox
6 Information Gathering for Risk Assessment
7 Developing the Quality Control Plan
8 Postimplementation Monitoring of the
  Quality Control Plan
References
Appendix A - Quick Guide Checklist for Establishing a
             Quality Control Plan Based on Risk Management
Appendix B - The Laboratory Risk Assessment: Example
             Glucose Measurement Using an Automated
             Measuring System
Appendix C - Summary of Laboratory Risk Assessment Table -
             Example: Glucose Measurement on an Automated
             Measuring System
Appendix D - The Quality Control Plan Developed From the
             Individual Components of the Quality Control
             Strategies From Appendixes B and C - Example:
             Glucose Measurement on an Automated Measuring
             System
Appendix E - Example of Failure Investigation and Corrective
             Action for Glucose Measurement on an Automated
             Measuring System
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.