PACE / State of CA / State of FL

Interactive learning modules that employ a case-based approach to helping users implement a quality program in their laboratory or practice. Includes a review of the Quality System Essentials (QSEs).

Module 5

Customer Focus, Equipment, and Process Management


Released: February 8, 2021

Expires: February 9, 2025

Customer Focus, Equipment, and Process Management



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
  • Equipment
  • 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.