CLSI QMS25—Handbook for Developing a Laboratory Quality Manual is a useful tool for laboratories beginning to implement a QMS or those looking for a new perspective on laboratory quality management. CLSI QMS25 contains answers to commonly asked questions about quality manuals, suggestions for elements to include, useful appendixes, and templates for preparing quality management policies. Information in CLSI QMS25 aligns with the QMS approach published in CLSI QMS01.

CLSI QMS25-Ed2 replaces CLSI QMS25-Ed1, published in 2017. Several changes were made in this edition, including:

• Revising the Foreword and terminology subchapter to align with the current template
• Removing definitions that are now maintained in the CLSI Harmonized Terminology Database Quality Glossary
• Updating references to existing CLSI documents and inserting references to new CLSI documents
• Updating content to align with CLSI QMS011

CLSI QMS25 provides a structured means for laboratory management and personnel to develop a quality manual for the first time or to restructure and revise a quality manual from a laboratory’s existing administrative and quality documents. CLSI QMS25 can be used by: 

• New and current laboratory management personnel to learn about the QMS policies, processes, and procedures in their laboratory
• Laboratory quality managers for developing needed quality processes, procedures, and forms and for ensuring effective implementation of the QMS
• Medical laboratories
• Blood gas laboratories
• Blood donor and pretransfusion testing laboratories
• Clinical research laboratories
• Veterinary laboratories

Applicable portions of CLSI QMS25 can also assist public health and environmental laboratories meet international and national requirements for a quality manual.