CLSI QMS06

Quality Management System: Continual Improvement, 3rd Edition

This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline.

This document is available in electronic format only.

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

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Chairholder: Anne T. Daley, MS, CMQOE(ASQ)CSSBB, CLC(AMT), MT(ASCP)DLM

Date of Publication: June 30, 2011

Order Code PDF: CLSI QMS06A3E
ISBN Number: 1-56238-760-X

Order Code Print: print not available

Edition: Third

Pages: 128

CLSI QMS06 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document was formerly sold under the code GP22.

CLSI QMS06 Abstract

Clinical and Laboratory Standards Institute document QMS06-A3—Quality Management System: Continual Improvement; Approved Guideline—Third Edition includes written and graphic descriptions of fundamental processes and common supporting elements in a continual improvement program. It provides the user with definitions, concepts, models, and tools for implementing an effective program. The fundamental processes include identifying opportunities for improvement (OFIs); selecting an opportunity; generating solution(s); implementing solution(s); evaluating the effect of solution(s); and integrating and sustaining improvement(s). These processes are supported by common elements of management review; teamwork; improvement models and tools; documents and records; change management; risk management; and communication.