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.
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.
It is said that “necessity is the mother of invention.” It is an idiom that has been adopted from the more specific insight of Greek philosopher Plato. In Republic, Plato writes, “A need or problem encourages creative efforts to meet the need or solve the problem.”
In September, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated high-level system (HLS) quality management system standard that includes some fundamental changes in how organizations are expected to operate to remain in conformance.
Quality management professionals focused their eyes on the big update to ISO 9001 in September, and changes in the standard will require top leadership to do the same moving into the new year and beyond.
RISK IS GIVEN A FRONT-AND-CENTER PRESENCE IN SECTION 6 OF THE STANDARD.
October 2, 2015
Years in the making, the ISO 9001:2015 revision has been published. Prior to the release date, auditors, inspectors, quality managers, and many others studied the initial drafts in an attempt to understand the changes.