6 Must-Haves For A Quality Management System (QMS)

What is the true cost of quality? While many companies may struggle to put an exact dollar amount on it, they do recognize that a lack of quality can lead to costly rework, scrap, product recalls, and even legal consequences. A more positive way to frame this is to ask: how much value does quality bring? High quality not only lowers costs but also drives increased sales, strengthens brand reputation, and enhances productivity.

In regulated environments, such as those overseen by the U.S. Food and Drug Administration (FDA) or the International Organization for Standardization (ISO), maintaining quality is not merely a business advantage but a requirement. Compliance with these regulations and standards mandates the implementation of a strong quality management system (QMS).

The FDA cautions that testing alone is not enough to ensure product integrity. Similarly, the ISO 9000 series of standards underscores the need to integrate quality into every facet of manufacturing operations. Today, achieving this requires the use of automated manufacturing processes and digital systems.