Lessons in Incremental Improvement of a Quality System for Developing Medical Image Management Systems
Abstract
Medical image management systems are fundamental to enterprise imaging in healthcare facilities and one of the building blocks in the establishment of an Electronic Medical Records system. MIMS are classified as medical devices by all major industrialized countries and come within the sphere of quality systems regulations in those countries.This presentation steps through the evolution of the Design Controls section of the McKesson Medical Imaging Group's quality system, from initial establishment through to compliance with the US FDA Quality Systems Regulation, ISO 9001:1994, Health Canada's CMDCAS system and ISO 13485:1996 and onto ISO 13485:2003 and CMMI L2. Insights are offered for meeting quality systems requirements in the face of common business constraints, software development challenges, and conflicting priorities.
About Robert MacNeil
Robert MacNeil P.Eng. is Manager of Quality and Regulatory Affairs for McKesson Medical Imaging Group. His entire working life has been in the medical devices industry, including over eighteen years experience in quality and regulatory affairs, primarily with software controlled medical and surgical devices. He has lead McKesson through two ISO quality system registrations, both of which were obtained on their first attempt.Past Meetings
