6.1 Introduction to Quality Management Systems
Learning Objectives
By the end of this chapter, you should be able to
- Describe the components of a quality management system
- Describe responsibilities within a quality management system
- Describe the purpose of policies, procedures, and standards
- Describe documentation and record-keeping responsibilities related to sterile reprocessing
Chapter Overview
In the Medical Device Reprocessing Area (MDRA), quality and effective practice is integral to patient outcomes, personal safety, and adherence to organizational policies. This chapter will discuss quality management systems (QMS), which are used to ensure that all processes are performed the same way each time, providing consistent outcomes. This results in a quality product that meets the needs and expectations of the user, as well as the requirements of governing standards, guidelines, and laws. Anyone working in the MDRA needs an understanding not just of this system, but also why the system is so important. This chapter will explain the concept of the QMS, key performance indicators (KPIs), and the role leadership plays in the QMS.
