Which is more important to you: complying with industry and federal regulations, or improving the efficiency and profitability of your operations?

I was recently retaught a lesson that, ironically, I teach for a living. The consulting firm I work in covers not only lean, but also consults and guides clients along with building and improving their quality management systems.

Quality 4.0 must be a significant contributor to the Industry 4.0 revolution happening in manufacturing, however, right now there is a significant gap between the two. 

A focus on customers should help any organization improve. Satisfy the customer and success will follow, or so the thinking goes. And it makes sense. Without customers, the best product or service is irrelevant.

Many times, in the world of quality, there are resources available that are unknown to many of our colleagues. One of these resources is the standard ISO 10012: 2003, “Measurement management—Requirements for measurement processes and measuring equipment.”

For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.

ISO 9001:2015 Quality Management System certification makes companies demonstrate their commitment to meeting the highest standards of quality and customer satisfaction. It provides support in continuously improving your quality management systems as a competitive advantage.

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 these highly competitive times, it may seem as though improving productivity is the key to market share. Manufacturers often focus on improving productivity and managing, controlling and reducing costs. 

FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.