It shouldn’t come as a surprise, but even after all these years the ISO9001 quality management system (QMS) requirements still come under attack and mostly from those in the quality profession. I recently read another super critical appraisal of ISO9001 from someone who commented they were on the “front lines.” I’m not sure what front lines they’ve been on, but it’s obviously not the same ones I’ve been on.
We hear these words all the time, but what do they really mean?
November 1, 2016
Imagine this scenario for two potential hires. Looking to build his résumé and gain some credibility in the quality world, Candidate A takes a few courses on quality from an accredited university, and upon completion receives a certificate in quality systems.
Things not working together. We’ve most likely all experienced it or witnessed a friend, colleague or family member struggle with it. Recently, hearing a colleague’s frustration I approached his desk to see what was happening.
ISO 9001:2015 was created as a High Level System (HLS). By virtue of being a HLS, the design of the new standard is for other standards to align themselves accordingly by integrating the elements and changes within the context of the principles required in the elements for 9001.
New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.