Table of Contents

Preface<br>Introduction<br>1 Scope<br>2 Reference publications<br>3 Definitions and abbreviations<br>4 Quality management system<br>5 Pre-validation - Determination of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;test requirements<br>6 Validation experiments<br>7 Post-validation<br>Annex A (informative) - Recommended resources<br>Annex B (informative) - Process overview

Abstract

Defines the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN