shop now
clinical laboratory standards institute logo


News & Events

CLSI Publishes a New Version of The Key to Quality™, a Fundamental Resource for Implementing a Quality Management System

Wayne, Pennsylvania, USA—August 2013—The Clinical and Laboratory Standards Institute (CLSI) has published an updated version of its popular resource for implementing a quality management system (QMS)—The Key to Quality. The Key to Quality is a workbook designed to provide laboratories with the tools and understanding to develop a QMS. It is intended to help laboratories meet accreditation quality requirements, encourage greater efficiency and productivity, and provide the highest quality test results.

A QMS directs and controls an organization with regard to quality. It uses a systematic and process-oriented approach that is essential to meet quality goals and objectives. The Key to Quality includes the fundamental information needed to implement, manage, and sustain a QMS.

The new version of The Key to Quality features ready-to-use templates that allow laboratories to implement their own customized QMS. This version of the workbook includes updated examples, as well as a QMS slide presentation that can be used to introduce laboratory workers to the CLSI QMS.

“The Key to Quality workbook provides a simple approach, guidance, and examples for implementing or improving upon an existing quality management system, along with assessment tools to identify the gap between existing laboratory processes and those needed in a quality management system,” stated Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), Chairholder of the Working Group on The Key to Quality, and Quality Director at Lab Corp of America, Burlington, North Carolina, USA.

The Key to Quality introduces users to a technique called “gap analysis,” which identifies what aspects of a QMS a laboratory already has in place and what is needed. The workbook includes gap analysis tools specific to each quality system essential (QSE), as well as an electronic application to assist laboratories in calculating their own gap analysis score. These tools help laboratories analyze their own situation to gain the necessary information to create a customized implementation plan. The Key to Quality also has the vital tools to monitor the progress of this unique QMS implementation.

CLSI also offers learning opportunities for QMS implementation through its new Laboratory Quality Management System (LQMS) Certificate Program. The online, self-paced distance learning course provides the comprehensive education needed to meet accreditation quality requirements and features case studies for each QSE. Paired with The Key to Quality, the LQMS Certificate Program is an invaluable resource for any laboratory to meet its QMS needs.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call 610.688.0100.



6 × = six

Register | Lost your password?