Upgrading from 9001 to 13485 can be costly in implementation and maintenance. If you are only making raw materials, is it necessary to do this?...
Daliane, This should help you. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm Regards.
Off-site, or virtual, or remote, or in a fancier way e-, auditing is not a new concept. With emails, videoteleconf, software that allows screen...
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