Clinical and Laboratory Standards Institute product QMS25—Handbook for Developing a Laboratory Quality Manual is a useful tool for laboratories just beginning to implement a QMS or those looking for a new perspective on laboratory quality management. This handbook 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 this handbook aligns with the QMS approach previously published in CLSI document QMS01 and CLSI product The Key to Quality™.

This handbook 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. 

This handbook 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 and public health laboratories 

- Blood gas laboratories 

- Research laboratories 

- Veterinary laboratories 

Applicable portions of this handbook can also assist public health and environmental laboratories meet international requirements for quality manuals.