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Re: QUERY: Declaration of Conformity in User Documentation
Subject:Re: QUERY: Declaration of Conformity in User Documentation From:"Jonathan West" <jwest -at- mvps -dot- org> To:"TECHWR-L Whirlers" <techwr-l -at- lists -dot- techwr-l -dot- com> Date:Mon, 1 Sep 2008 10:32:36 +0100
2008/8/31 Gene Kim-Eng <techwr -at- genek -dot- com>:
> Consult the regulation/s you're declaring conformity to.
> For European CE Mark and US FDA, signed declaration
> at the front of the document is SOP. Others most likely
> vary. If you are required to provide a DoC, the format
> will probably never be "company's choice."
For the CE mark, the form of the declaration depends entirely on which
particular regulation you claim conformity with. There are quite a few
regulations which don't require any particular form of declaration,
since placing the product on the market and applying the CE mark is in
itself a declaration of conformity with the relevant EU regulations.
If you want to be sure you have it right, there is no alternative but
to read the relevant regulations and find out what they require.
The whole thing rather reminds me of a Dilbert cartoon from many years ago.
Salesman: This product meets all international standards for telecommunications.
Dilbert: So, what you mean is that it doesn't work and it's not your fault.
Salesman: Is there someone less qualified I could speak to?
Dilbert: Have you tried my boss?
Regards
Jonathan West
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