scope:

This guideline is intended to assist laboratories in meeting the leadership-based requirements for their QMS, as represented by quality system essential (QSE) Organization. A conceptual framework comprising three organizational dimensions (ie, cultural, structural, and functional) is presented, and content is provided to illustrate relevance to managing laboratory quality. This guideline's content was developed with the aim of enhancing leadership's effectiveness at shaping these dimensions, and thereby supports leaders in the fulfillment of their roles and QMS responsibilities.

This guideline is intended for use by all organizations and individuals involved in the management or operation of preexamination, examination, and postexamination phases of the medical laboratory. This document may be applicable to other types of laboratories, as well as nonlaboratory settings.

This guideline does not address, in detail, topics and content covered in other CLSI documents. In addition, this document does not reference requirements specific to any regulation or accrediting body. It is not meant to be prescriptive, but rather suggestive in approach. It is not a comprehensive instructional manual for application of the concepts discussed, and does not include detailed instructions or plans for how to design an organizational structure, implement a QMS, allocate resources (eg, budgeting, staffing), or create a quality manual.