ISO Committee Drafting "Stand-Alone" Device Quality Standard
This article was originally published in The Gray Sheet
Executive Summary
The International Standards Organization (ISO) technical committee charged with revising ISO 13485 is crafting the medical device quality systems standard to be a "stand-alone" document separate from the widely used ISO 9001.
You may also be interested in...
ISO 9001:1994 Certification Recommended Prior To 2000 Update
Manufacturers lacking International Standards Organization (ISO) certification should work to gain compliance with the 1994 edition of ISO 9001 by the end of the year if they want to delay incurring higher costs associated with ISO 9001:2000 certification, CRO Group Senior Analyst Glen Emelock advised.
ISO 9001:1994 Certification Recommended Prior To 2000 Update
Manufacturers lacking International Standards Organization (ISO) certification should work to gain compliance with the 1994 edition of ISO 9001 by the end of the year if they want to delay incurring higher costs associated with ISO 9001:2000 certification, CRO Group Senior Analyst Glen Emelock advised.
ISO Customer, Quality Standards Should Not Apply To Medical Devices - SG3
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.