The future of enterprise quality management software is changing. Quality professionals across the globe are dealing with an astounding number of changes that correspond with new international standards and regulatory requirements, including the transition to ISO 13485:2016, ISO 9001:2015, IATF 16949:2016, as well as the upcoming transition to the new EU Medical Device Regulation (MDR). Additionally, FDA, in the recent Spring Unified Agenda, made it clear that the future goal is to harmonize and modernize regulation of Medical Device Quality Systems. The primary objective is to “reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements”.
The noted changes in the international regulatory landscape will have a direct impact on quality management system (QMS) design and implementation. Thus, this is an appropriate time to reveal a new approach to QMS thinking and analysis that will undoubtedly pave the way to the future of QMS architecture. With that said, the purpose of this white paper is to introduce some new and innovative concepts that are aimed at taking our current thinking into the future. And yes, this includes incorporating Artificial Intelligence into the design and architecture of a QMS.
In this paper, we will discuss: