CLSI MM14 A2 : 2ED 2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Survey of Regulatory and Guidance Documents
   Regarding Proficiency Testing
6 Design
7 Material Sourcing/Collection
8 Production/Manufacture
9 Transportation of Samples for Proficiency
   Testing Programs
10 Documentation to Exchange Information
11 Provider Results Review and Evaluation
12 Complementary and Supplementary Approaches to
   Proficiency Testing/External Quality Assessment Programs
References
Appendix A - Globally Influential Documents Addressing
             Proficiency Testing: Relevance to and impact
             on Stakeholders
Appendix B - Process Checklist Example
Appendix C - Useful Websites for Information in Shipping
             Proficiency Testing/External Quality
             Assessment Samples
Appendix D - Example Registration Form for Proficiency
             Testing/External Quality Assessment
             Challenge/Scheme
Appendix E - Example Instructions Manual
Appendix F - Example of Clinical Information Related to
             the Proficiency Testing/External Quality
             Assessment Sample
Appendix G - Example sections From a Proficiency
             Testing/External Quality Assessment Result
             Reporting Form
Appendix H - Example Confidentiality Form
Appendix I - Example Data From a Participant Summary Report
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.