Standard Document
Fifth Edition
Quality Management Systems

CLSI QMS01

A Quality Management System Model for Laboratory Services

CLSI QMS01 Ed5 provides guidance to help your lab reduce and prevent nonconformances to ensure it stays in regulatory compliance while fitting your labs unique needs. Learn how to keep your lab safe and functional with the proper development and implementation of quality management systems that translate the top patient care and outcomes.

June 19, 2019
Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSBB, CLC(AMT) and Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE

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Abstract

Clinical and Laboratory Standards Institute guideline QMS01—A Quality Management System Model for Laboratory Services provides the necessary background information and infrastructure to develop a quality management system that meets the laboratory’s quality objectives and is consistent with the quality objectives of health care services. This guideline provides a structure for a comprehensive, systematic approach to building quality into the laboratory’s processes, assessing the laboratory’s performance, implementing quality improvements, and assisting in preparing for or maintaining accreditation.

Overview of Changes

This guideline replaces the previous edition of the approved guideline, QMS01-A4, published in 2011. Several changes were made in this edition, including: 

• Shifted focus from process and procedural details for implementing the CLSI QMS model to an overview of specific required processes in the QMS, with referral to the library of QMS guidelines listed in the Related CLSI Reference Materials section for process and procedure details 

• Described the patient’s relationship to the QMS 

• Aligned guidance with any new or changed international, regulatory, and accreditation requirements for laboratories since the last edition 

• Added suggestions for providing a rationale to laboratory leadership for implementing and maintaining a QMS 

• Described a practical strategy for implementing a laboratory QMS

Scope

The QMS model described in this guideline can be used in laboratories worldwide. This guideline is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Clinical research laboratories

However, the QMS model is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

The 12 quality system essentials (QSEs) described in this guideline are universal and applicable to any size laboratory, whether simple or complex, and any laboratory discipline. This guideline is intended for laboratory directors, managers, supervisors, quality managers, and others responsible for implementing, evaluating, and maintaining the laboratory’s QMS.

Product Details
QMS01Ed5E
978-1-68440-044-7
214
Additional Details

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

Authors
Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSBB, CLC(AMT)
David Kimes
Elizabeth McBride, MLT, BSc, MLS, LQM, CQA(ASQ)
Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Laura McClannan, MS, MT(ASCP)SBB, CQA(ASQ)
Kris R. Arney, MT(ASCP)
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Connie Lien Adams
Tania Motschman, MS, MT(ASCP)SBB
Jenny Bazov, MSc, CQA(ASQ)
Amy Pennock, MS, CQE(ASQ)
Michael B. Cohen, MD
Tiea Theurer, MT(ASCP), MQ/OL(ASQ), MPA, PMP, CQE(ASQ)
Kenra Ford, LSSGB, MBA, MT(ASCP)
Janette Wassung
Mary Galloway, MS
Supporting Resources
CLSI QMS01CL
Gap Analysis Checklists, 1st Edition
Companion
Quality Management Systems
Free
Abstract

Clinical and Laboratory Standards Institute guideline QMS01—A Quality Management System Model for Laboratory Services provides the necessary background information and infrastructure to develop a quality management system that meets the laboratory’s quality objectives and is consistent with the quality objectives of health care services. This guideline provides a structure for a comprehensive, systematic approach to building quality into the laboratory’s processes, assessing the laboratory’s performance, implementing quality improvements, and assisting in preparing for or maintaining accreditation.

Overview of Changes

This guideline replaces the previous edition of the approved guideline, QMS01-A4, published in 2011. Several changes were made in this edition, including: 

• Shifted focus from process and procedural details for implementing the CLSI QMS model to an overview of specific required processes in the QMS, with referral to the library of QMS guidelines listed in the Related CLSI Reference Materials section for process and procedure details 

• Described the patient’s relationship to the QMS 

• Aligned guidance with any new or changed international, regulatory, and accreditation requirements for laboratories since the last edition 

• Added suggestions for providing a rationale to laboratory leadership for implementing and maintaining a QMS 

• Described a practical strategy for implementing a laboratory QMS

Scope

The QMS model described in this guideline can be used in laboratories worldwide. This guideline is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Clinical research laboratories

However, the QMS model is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

The 12 quality system essentials (QSEs) described in this guideline are universal and applicable to any size laboratory, whether simple or complex, and any laboratory discipline. This guideline is intended for laboratory directors, managers, supervisors, quality managers, and others responsible for implementing, evaluating, and maintaining the laboratory’s QMS.

QMS01Ed5E
978-1-68440-044-7
214
Additional Details

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

Authors
Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSBB, CLC(AMT)
David Kimes
Elizabeth McBride, MLT, BSc, MLS, LQM, CQA(ASQ)
Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Laura McClannan, MS, MT(ASCP)SBB, CQA(ASQ)
Kris R. Arney, MT(ASCP)
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Connie Lien Adams
Tania Motschman, MS, MT(ASCP)SBB
Jenny Bazov, MSc, CQA(ASQ)
Amy Pennock, MS, CQE(ASQ)
Michael B. Cohen, MD
Tiea Theurer, MT(ASCP), MQ/OL(ASQ), MPA, PMP, CQE(ASQ)
Kenra Ford, LSSGB, MBA, MT(ASCP)
Janette Wassung
Mary Galloway, MS
Supporting Resources
CLSI QMS01CL
Gap Analysis Checklists, 1st Edition
Companion
Quality Management Systems
Free