Abstract
Committee Membership
Foreword
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 An Overview of a Manufacturer's Risk Management and Control
6 Risk Mitigations and the Type of Error Conditions Being
Monitored or Controlled
7 Risk Information Summary: Information Regarding Risk
Mitigations and Recommended User Interventions Intended to
Prevent Production or Release of Incorrect Test Results
8 Postmarket Monitoring
References
Additional References
Appendix A - A Manufacturer's Risk Mitigation Information
Provided to Users: An Illustrative Example of a
Glucose Measurement on an Automated Analyzer
Appendix B - A Manufacturer's Risk Mitigation Information
Provided to the Users: Illustrative Example of
a Molecular Diagnostic Unit-Use Device
The Quality Management System Approach
Related CLSI Reference Materials