CLSI QMS14

Quality Management System: Leadership and Management Roles and Responsibilities, 1st Edition

This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory’s organization that are critical to managing and sustaining quality.

An executive summary of QMS14 is included with this guideline.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2017. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE and Tania Motschman, MS, MT(ASCPSBB; CQA(ASQ)

Date of Publication: January 25, 2013

Order Code PDF: CLSI QMS14AE
ISBN Number: 1-56238-861-4

Order Code Print: CLSI QMS14A
ISBN Number: 1-56238-861-4

Edition: First

Pages: 170

CLSI QMS14 Additional Details

This document was formerly sold under the code GP37.

CLSI QMS14 Abstract

Clinical and Laboratory Standards Institute document QMS14-A—Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline is intended to assist laboratories in meeting the leadership-based requirements for a QMS, as represented by quality system essential (QSE) Organization. It presents a conceptual framework comprising three organizational dimensions (ie, cultural, structural, and functional) and provides content relevant to the management of laboratory quality in the form of descriptions, examples, and sample templates. 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.