scope:

The quality management system model described in this guideline can be developed for any healthcare organization or individual service unit (e.g., laboratory, pharmacy, respiratory, imaging). The quality system essentials are universal and thus can be applied to any service's operations, whether simple or complex. It is recommended that this guideline be used in conjunction with the NCCLS disciplinespecific companion documents to establish and maintain technical and managerial quality.

This guideline is intended for use by laboratory directors, managers, supervisors, the quality manager, and others responsible for implementing the policies, processes, procedures, activities, and records that support the quality management activities described h