scope:

The quality management system (QMS) model described in this guideline can be used in laboratories around the world including, but not limited to:

• Medical laboratories

• Public health laboratories

• Research laboratories

• Veterinary laboratories

• Food laboratories

• Environmental laboratories

The 12 quality system essentials (QSEs) described in this guideline are universal and applicable to any size laboratory, whether simple or complex, in any laboratory discipline. This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, and others responsible for implementing, maintaining, and evaluating the laboratory's QMS.