Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives and manufacturing personnel understand the benefits of a QMS, patient outcomes improve, the quality of life is enhanced, and manufacturers prosper.
In the medical devices field, where I’ve practiced for 30 years, I have seen a fair amount of ignorance about the benefits of quality management. Inevitably, I’ve also witnessed the results of inadequate quality management—device recalls, lawsuits and unfortunately, injury, even death.