In message
<bn3pr0801mb097985bfe1773ece195b9c5285...@bn3pr0801mb0979.namprd08.prod.o
utlook.com>, dated Tue, 17 Mar 2015, "Nyffenegger, Dave"
<[email protected]> writes:
Annex VII states the technical file shall include ?a copy of the EC
declaration of conformity;? Don?t know if this implies a copy of every
unique original with signature and/or serial number needs to be kept or
only the original that is then signed for each unit or batch or
whatever a manufacturer decides to do.
I think it can be simplified to 'Save every unique DoC'. If a single DoC
covers hundreds or thousands of units produced over some years (so not
an MD Doc), just save one. If a serial number must be on the DoC, or
each DoC is unique in some other way, then save every one.
In any case, we know the technical file must be kept for 10 years as
well as the DoC, it seems to me filing as many copies of DoCs as one
might have with the technical file (either electronically or hard copy)
would logical.
Yes, that is the wisest course of action. Electronic storage, of course.
You can't be criticized by Market Surveillance for preserving too much
information.
--
OOO - Own Opinions Only. With best wishes. See www.jmwa.demon.co.uk
When I turn my back on the sun, it's to look for a rainbow
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc discussion
list. To post a message to the list, send your e-mail to <[email protected]>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used
formats), large files, etc.
Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <[email protected]>
Mike Cantwell <[email protected]>
For policy questions, send mail to:
Jim Bacher: <[email protected]>
David Heald: <[email protected]>
