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Manuals for equipment that must conform to CE requirements to be sold in
the EU must contain a Declaration of Conformity. The DoC is a separate
document that lists the equipment, the standards that apply to the type
of equipment, and the certifying body. It must be signed by the person
in charge of ensuring that the equipment does comply, typically the
manager of the product development group.
Our company designs and sells many types of equipment for which we must
obtain DoCs. We often must send the equipment and drawings to a
certifying body that tests it to ensure that it meets all the
requirements. These tests can be expensive and time-consuming. For other
less critical equipment we can self-certify, but the self-certification
can be challenged and if it is then the equipment must be tested.
A typical DoC contains the following information:
XX Corporation
declare under our sole responsibility that the products XX
to which this declaration relates complies with the following
Directives:
The conformity is under observance of the following standards or
standards documents:
EN12100 (1998)
EN1953 (1998)
EN60204 (2006)
EN60079-0 (2006)
EN50050 (2006)
EN61000-6-3 (2007)
EN61000-6-2 (2005)
EN55011 (2007)
FM7260 (1996)
Type of protection:
- Ambient temperature: +15_C to +40_C
- Ex tD A21 IP6X T 65_C / Ex II 2D (Applicator)
- Ex tD A22 IP6X T 60_C / Ex II 3 (2)D (Controllers)
No of EC type Certificate:
- SIRA08ATEX5010X (Eccleston, Chester, UK)
No of notified body (ATEX surveillance)
- 1180 (Baseefa) (Buxton, Derbyshire, UK)
ISO9000 certificate
DNV
Signature and Date
The above is the content of the DoC for a product which had to undergo
extensive testing before the DoC could be issued.
Peter Neilson stated:
"As a side issue, these certifications are generally set forth as part
of a "quality" effort, but actually have little or nothing to do with
quality. Instead they claim (but not not ensure) conformance to a
standard that could even *decrease* the level of quality of
documentation, for instance by requiring the material to be presented
badly. The ambiguity of location for the declaration might stem directly
from bad standards.
My wife the quality engineer says that yes, I am correct in my
understanding of this weird issue.
I wonder if people who design these standards (to which stuff is
supposed to conform) ever actually test the standards themselves, as
opposed to testing conformation to them? I'm thinking especially of
standards that do not scale well, so that a test on a minuscule document
(or perhaps on a pilot plant) looks ok, but on the full document set (or
the huge factory) the standards are invasively destructive."
This is NOT our experience. In the world of industrial equipment, the
standards typically deal with safety issues and try to ensure that the
equipment can be used safely. For instance, making sure that an
enclosure for electrical switches, relays, and PLCs is dust- or
liquid-tight and safe for use in a hazardous or explosive environment.
Granted, some of the tests required by the EU are way overboard, like
subjecting a plastic part to -40 C for 24 hours and then expecting it to
survive a drop test, when the equipment will never be used in such a
manner. However, I've been writing manuals and other documentation for
industrial equipment and mining equipment for 28 years and have never
had standards "decrease" the quality of documentation, other than the
occasional poorly written warning required by a certifying body. The
location of the DoC is not an issue, we normally include it as the last
page of the document.
Nick Klasovsky
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