Standard Document
First Edition
Quality Management Systems

CLSI QMS29

Management Review

CLSI QMS29 breaks down and describes the purpose of the management review process. This guide explains the intent of management review, input, who should be involved in the process and resulting action once a review is complete

March 11, 2024
Laura McClannan, MT(ASCP)SBB, CQA(ASQ)

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Abstract

Clinical and Laboratory Standards Institute QMS29—Management Review describes the purpose and process for management review, including who should be involved, how it can be conducted, inputs, and the decisions and outcomes for action once the management review is completed

Scope

CLSI QMS29 helps laboratories develop, implement, and maintain a management review process. This guideline describes the purpose of management review and includes detailed descriptions of the development of a management review process, preparation of review materials, performance of the review, recording of decisions and outcomes, and follow-up actions taken. Ideas for how to present data and information in management review materials as well as templates for recording management reviews are also discussed. 

CLSI QMS29 is designed primarily for use in medical laboratories; however, the concepts are generic and can be applied to research, public health, environmental, and veterinary laboratories. Regulatory and accreditation organizations could also benefit from the guidance provided. 

CLSI QMS29 does not include QMS information, e.g., continual improvement (CI) that might provide data for management review (see CLSI QMS06).

Product Details
QMS29Ed1E
978-1-68440-215-1
58
Authors
Laura McClannan, MT(ASCP)SBB, CQA(ASQ)
Julie Coffey, MLT, ART, CMQ/OE(ASQ)CQA
Lucia M. Berte, MA, MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSSBB
Tara Eason, MT(AMT), MBA, CQA(ASQ)
Amanda Faber, MLS(ASCP)CM, MB(ASCP)CM
Joseph Ferreira, MBA-HCM, BS, LSSMBB
Nicole A. Gregoricus
Milly Keeler, BS, MLS(ASCP), CLC(AMT), CCCP
Kassandra Larson, MHA, MBA, HLT(ASCP)
Beth Luhowy, MLT
Abiola Lyons, BSc, CQIA(ASQ), RPT/MLT(AMT)
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Eric Nyirenda, MPH, BSc, CQM/OE(ASQ)CQA, CSSBB, PMP(PMI)
Jennifer Ord
E. Jayne Scoggin, BA, CT, CG, MB(ASCP), CQA(ASQ)
Jean Tenuta, MS, MBA, BA, MLS(ASCP)CM, DLM(ASCP), SLS(ASCP)
Arno Pieter Theron
Wren Williams
Supporting Resources
CLSI QMSGAP
Gap Analysis Tool
Subscription
Free
Abstract

Clinical and Laboratory Standards Institute QMS29—Management Review describes the purpose and process for management review, including who should be involved, how it can be conducted, inputs, and the decisions and outcomes for action once the management review is completed

Scope

CLSI QMS29 helps laboratories develop, implement, and maintain a management review process. This guideline describes the purpose of management review and includes detailed descriptions of the development of a management review process, preparation of review materials, performance of the review, recording of decisions and outcomes, and follow-up actions taken. Ideas for how to present data and information in management review materials as well as templates for recording management reviews are also discussed. 

CLSI QMS29 is designed primarily for use in medical laboratories; however, the concepts are generic and can be applied to research, public health, environmental, and veterinary laboratories. Regulatory and accreditation organizations could also benefit from the guidance provided. 

CLSI QMS29 does not include QMS information, e.g., continual improvement (CI) that might provide data for management review (see CLSI QMS06).

QMS29Ed1E
978-1-68440-215-1
58
Authors
Laura McClannan, MT(ASCP)SBB, CQA(ASQ)
Julie Coffey, MLT, ART, CMQ/OE(ASQ)CQA
Lucia M. Berte, MA, MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSSBB
Tara Eason, MT(AMT), MBA, CQA(ASQ)
Amanda Faber, MLS(ASCP)CM, MB(ASCP)CM
Joseph Ferreira, MBA-HCM, BS, LSSMBB
Nicole A. Gregoricus
Milly Keeler, BS, MLS(ASCP), CLC(AMT), CCCP
Kassandra Larson, MHA, MBA, HLT(ASCP)
Beth Luhowy, MLT
Abiola Lyons, BSc, CQIA(ASQ), RPT/MLT(AMT)
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Eric Nyirenda, MPH, BSc, CQM/OE(ASQ)CQA, CSSBB, PMP(PMI)
Jennifer Ord
E. Jayne Scoggin, BA, CT, CG, MB(ASCP), CQA(ASQ)
Jean Tenuta, MS, MBA, BA, MLS(ASCP)CM, DLM(ASCP), SLS(ASCP)
Arno Pieter Theron
Wren Williams
Supporting Resources
CLSI QMSGAP
Gap Analysis Tool
Subscription
Free