Re: QUERY: Declaration of Conformity in User Documentation

["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."

Gene Kim-Eng


----- Original Message ----- 
From: "SB" <sylvia -dot- braunstein -at- gmail -dot- com>
To: "TECHWR-L Whirlers" <techwr-l -at- lists -dot- techwr-l -dot- com>; 
<COPYEDITING-L -at- listserv -dot- indiana -dot- edu>
Sent: Sunday, August 31, 2008 10:06 AM
Subject: QUERY: Declaration of Conformity in User Documentation


> In our User Documentation, as part of the declarations and certifications
> section, our declaration of conformity is a sentence saying that we comply
> to the required standards.
>
> However, I was told that this was wrong and that we needed to be move it to
> the very beginning of the manual, using a formal document with the address
> and the signature of the person in charge.
>
> I have looked through various documents and I find that indeed, some do have
> a short version at the beginning of the document but without signature, and
> some like us have it as part of the declarations and certifications section.
> Is this really not correct?
>
> I only saw one single company that actually signed that document and
> included it in their documentation. Is this customary and is this actually a
> requirement or best practice or is it the company's choice?

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