ISO Customer, Quality Standards Should Not Apply To Medical Devices - SG3
This article was originally published in The Gray Sheet
Executive Summary
Language mandating customer satisfaction and continuous improvement in the revised ISO Draft International Standard (DIS) 9001:2000, should not be included in quality development standards for medical devices the Global Harmonization Task Force Study Group 3 maintains in comments to ISO Technical Committee 176 and Technical Committee 210 Working Group 1.