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.
Undoubtedly, you have heard—perhaps spoke—the first two statements. You are in the business of process improvement, after all. You want to be sure you have an effective quality management system (QMS).
When people use the word “Quality,” it’s usually as a synonym for “good.” Many brands tout their products as “high quality” or “superior quality” in just this way without really defining what the characteristics of “Quality” are, and we’re more likely to see it in marketing material than in integral business process or policy documents.