scope:

The QMS model 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

• Clinical research laboratories

However, the QMS model is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

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