The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.

Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.

In his Quality Digest article published in February 2023, Michael Mills¹ reported that the next version of ISO 9001 will add to clause 4.1, “Understanding the organization and its context” the words, “the organization shall determine whether clima

As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”

When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance.

An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.

Reactive maintenance is a form of physical asset management in which maintenance is only performed on equipment or machinery when it malfunctions or fails entirely.

ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.

Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House.

In manufacturing industries, calculating overall equipment effectiveness (OEE) offers deep insights into the performance of production processes and enables data-driven impr