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.
Spires succeeds Peter Unger, who served as A2LA’s president and CEO for 20 years and continues to support the association in his position as president emeritus.
Advances in camera, sensor, and video interface technologies have helped power the continuing development of machine vision solutions for manufacturing and quality inspection that far surpass the abilities of any human.
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.
“The true measure of a successful NDT training program lies in the student’s ability to demonstrate that the body of knowledge was thoroughly comprehended and that the skills to effectively perform the nondestructive tests have been achieved. This should be the goal of all NDT courses.”