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.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical 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.
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
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
Free
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.
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
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.