This chapter explores the quality management system re-prioritization efforts employed by Rapid Acceleration of Diagnostics (RADx®)-supplied content experts to support rapid product development and commercialization of COVID-19 diagnostic tests. The chapter also explores the interplay between quality, development, manufacturing, and risk management. While the chapter is applicable to companies of all sizes, particular emphasis is placed on describing a roadmap for small businesses and start-ups without the mature quality management systems and teams in place that a larger company may have.

This chapter seeks to give an overview of the place of Quality Management (QM) in contemporary fertility practice. It provides the reader with an understanding of the terminology used in QM and explores the definition of quality and success in fertility care. An examination of process modelling in the organisation of services is outlined and an analysis in practical terms as to how QM is applied in practice is provided, covering key issues such as document control, organisational structure and the role of the quality manager. Audit as a tool for improving quality is a fundamental tool and its use within a clinical governance framework including risk management/assessment, and other key responsibilities is detailed. Measuring what we do, analysing performance and setting targets to improve should be fundamental to how we approach our work in contemporary clinical practice.