Customer Focus, Equipment, and Process Management
Released: February 8, 2021
Expires: February 9, 2025
This module will explore the elements of a quality management system (QMS) based on the Clinical and Laboratory Standards Institute (CLSI) guidance document: CLSI QMS01-ED5:2019. This module will use a case study format to explore components within the following quality system essentials (QSEs):
- Customer Focus
- Process Management
- Describe the value of completing a stakeholder analysis when implementing a new or significantly modified test.
- Identify key steps to take when bringing in a new piece of equipment.
- Explain why a structured plan for controlling changes in the laboratory is important.
- Assess strengths and limitations of your organization’s current practices related to the key components outlined in this module.