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.
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.
During my courses preparing quality professionals to successfully take certification exams offered by American Society for Quality (ASQ), one topic that constantly comes up is the challenge of getting organizational management to support quality initiatives.
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.