A quality management system (QMS) is a structure based on a set of key quality elements that must be in place in order for an organization’s operations to:

• Operate efficiently and effectively, meeting regulatory requirements
• Be managed with the interest of the patient
• Ensure that everyone understands who is responsible for doing what, when, why, where and how
• Continually strive for improvement

The LLSG QMS is modeled on the Clinical Laboratory Standard Institute’s (CLSI) guideline HS1. The QMS is structured on twelve Quality System Essentials (QSE’s) that are the foundational building blocks which apply to all operations across the path of workflow. Documented policies, processes and procedures address the activities related to each QSE.