CSA Z316.8-18 (R2023)

This is the first edition of CSA Z316.8, Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions.

This Standard specifies 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.

It does not provide specific details on how to achieve these requirements since they are provided in many other sources which are considered current best practice. References to these resources will be provided in this Standard.