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.
While there are many important quality management principles, this time we will look at continuous improvement. Perhaps the idea most commonly associated with quality, it means never being satisfied with the status quo.
Most people would agree that quality is essential to have but difficult to execute. Among the many tools available, a quality management system (QMS) can provide a roadmap toward better quality.
The requirements of ISO 9001:2015 are viewed and implemented very differently by organizations, depending upon such variables as their size, resources, business sector, maturity, and external requirements.
The importance of nondestructive testing training cannot be overstated. What nondestructive testing technicians do every day has a huge impact on the lives around them. Well trained and qualified technicians provide accurate results for prevention of failures in components or structures.
It’s intended to extend the benefits of a quality system.
April 2, 2018
Whether your business has a 50-year history or just opened last year, you need to make sure you have a system of sustained success. ISO Q9004: Quality Management Systems–Managing for the Sustained Success of an Organization “provides guidance to management for achieving sustained success of any organization in a complex, demanding, and ever-changing environment.”
More than ever before, plastics are being used to manufacture consumer and commercial goods across the world. From medical devices to automotive fasteners, plastics have made their way into nearly every industry.
In 2017, much of the ISO standards user community, as well as the supporting third party certification industry, was left with the same question. What standards/specifications aren’t changing right now?