scope:

This guideline is intended for use by laboratory leaders, such as directors, managers, and supervisors, as well as other laboratorians who perform laboratory testing. This guideline focuses on using an internal audit program to actualize the laboratory's commitment to quality, good professional practice, and continual improvement by identifying problematic processes. The audit program described in this guideline can be used in laboratories worldwide. This guideline is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Research laboratories

The examples provided are applicable to laboratories of any size and functional complexity. This guideline is not intended for use by laboratories involved in examinations for clinical trials, because the requirements applied to those laboratories are more stringent. This guideline does not include audit program details available in published materials on auditing.