Clinical and Laboratory Standards Institute document QMS06-A3—Quality Management System: Continual Improvement; Approved Guideline—Third Edition includes written and graphic descriptions of fundamental processes and common supporting elements in a continual improvement program. It provides the user with definitions, concepts, models, and tools for implementing an effective program. The fundamental processes include identifying opportunities for improvement (OFIs); selecting an opportunity; generating solution(s); implementing solution(s); evaluating the effect of solution(s); and integrating and sustaining improvement(s). These processes are supported by common elements of management review; teamwork; improvement models and tools; documents and records; change management; risk management; and communication.

This document replaces the second edition of the approved guideline GP22-A2, which was published in 2004. Several changes were made in this edition, including the following:

- Expansion of the five key quality system components to a CI program that includes discussion on CI fundamental processes and CI common supporting elements

- Alignment with new or changed international, national, and accreditation requirements for laboratories since the last version of this guideline

- Additional examples of documents and forms that can be used or modified as needed for implementing a CI program

This guideline includes written and graphic descriptions of the fundamental processes and common supporting elements in a continual improvement (CI) program. It provides the user with definitions, concepts, methods, and tools for implementing an effective program and meeting applicable requirements. The CI fundamental processes include the following:

- Identifying opportunities for improvement (OFIs)

- Selecting an opportunity

- Generating solution(s)

- Implementing solution(s)

- Evaluating effect of solution(s)

- Integrating and sustaining improvement(s)

The CI common supporting elements include, but are not limited to:

- Management review

- Teamwork

- Improvement models and tools

- Documents and records

- Change management

- Risk management

- Communication

This guideline is intended for use by all organizations and individuals involved in the management or execution of preexamination, examination, and postexamination phases of the medical laboratory. This document may be applicable to other laboratories and nonlaboratory settings.

This guideline is not meant to be prescriptive nor a comprehensive instructional manual for using the tools described. It does not address content and detail covered in other CLSI documents nor requirements specific to any regulatory or accrediting organization.