Re: CE documentation (long)

[Geoff Lane <geoff -at- GJCTECH -dot- FORCE9 -dot- NET>]

Rebecca Siegel wrote:

>I've checked the archives and haven't found much discussion on this
>topic, so I'm writing to the list in hopes that some of you have
>experience in this area.
>
>The company I work for develops hardware and software. We're just now
>moving into the international market with our newest hardware product
>(we're located in the U.S.) and need to have CE approval. The product
>developers tell me we can't get CE approval without the proper
>documentation. They gave me the official requirements document, which
>lists a lot of requirements but shows no examples.
>
>Since this is new to me, I'd really like to see a sample of how someone
>else has done this. Can anyone tell me how to tackle this, or does
>anyone have a sample set of CE doc pages they can send me?
---

Hopefully, this is on-topic because one client required me (as a tech
writer) to produce technical files for the company's product range.  To do
this, I researched the legal requirements, attended numerous seminars, and
discussed the client's particular problems with the UK enforcers.  I
summarise below.  However, this is the 'tip-of-the-iceberg'.

Numerous CE Marking Directives exist, each covering a specific product
range.  When you CE mark a product, you are declaring that the product meets
with the requirements of *all* applicable CE marking legislation.  For
example, mark a motor-driven guillotine and you declare that it meets both
the Machinery Directive and the Electromagnetic Compatibility Directive.

You don't "get approval" -- you (the manufacture or manufacturer's agent)
*declares* that the product conforms to requirements.  Unfortunately, the
manufacturer or manufacturer's agent *must* be established within the EEC.
If you are not established and do not have an agent, the burden of declaring
conformity lies with the importer.  The minimum that you need do to legally
sell a product within the EEC is:

1. Be established within the EEC.
2. Declare that your product conforms to all applicable CE marking
legislation for the European country in which you are established.
3. Apply the CE mark to the product.

Declaring Conformity
====================
You only need reasonable grounds to *presume* conformity before making your
declaration.

If you manufacture your product to a European Normalised Standard (.. EN ..)
that is specific to that product type then you can presume conformity to all
applicable directives.  In such cases, your technical file should consist of
(as minimum):
* a list of applied product-specific EN standards.
* all the documents that the EN standard requires.
* a copy of any manual(s) that accompany the product.
* your declaration of conformity.

If you manufacuture to one or more generic EN standards, that is, not
specific to your product type, then you need to show that the standard(s)
cover all essential requirements of all applicable directives.  For example,
you can produce a report that compares each directive's requirements with
those of the standard.  Generic standards usually exceed the
product-specific ones.  However, you may find instances where the standard
does not meet the directive's requirements.  In such cases, you should
gather evidence that your product does meet the uncovered requirements.  For
such products, your technical file should consist of:
* a list of applied EN standards.
* all the documents that the standards require.
* evidence that your product meets any requirements not covered by the
  standards.
* a copy of any manual(s) that accompany the product.
* your declaration of conformity.

If you do not manufacture to any EN standards then you may apply
international, national, regional, or company standards.  However, you
should show that the combination of standards that you have chosen meet or
exceed the directives' requirements.  In such cases, your technical file
should consist of:
* a list of applied standards.
* evidence that the standards meet or exceed the requirement of all
  applicable directives.
* evidence that your product meets any requirements not covered by the
  standards.
* a copy of any manual(s) that accompany the product.
* your declaration of conformity.

If you do not manufacture to any standards then you can still declare
conformity by direct application of the essential requirements of all
applicable directives.  The easiest way to do this is to create check-off
lists from the stated requirements.  For each list item, include the
regulation and paragraph that the item represents.  You assess the product
against this list, making comments that will support your claim of
conformity.  For such products, your technical file should consist of:
* The list of essential requirements.
* Evidence (e.g. your comments and test results) that the product meets each
  requirement.
* a copy of any manual(s) that accompany the product.
* your declaration of conformity.

In addition to the above, some products (for example, wireless telegraphy
and medical equipment) require certification (type-approval) by EEC-approved
testers (notified bodies).

Manuals
=======
Within Europe, and particulary for machinery, "instructions" are now legally
part of the product.

The Machinery Directive (and possibly others) explicitly require that
manuals accompany the product.  The manuals must also be translated into a
major language of end-customer's country.  The manuals *must* include
certain information.  For example, you must include shock and vibration
figures for hand tools.  You must include sound level figures for all
machinery.

Finally, a simple check-off list:
1. Identify all directives (there are over forty of them) and decide which
   apply to your product.
2. Identify all the standards to which you manufacture.
3. Establish reasonable grounds to presume conformity with all applicable
   legislation.
4. Prepare a technical file.  In this file, store actual documents (and/or
   links to documents) that support your presumption.
5. Declare conformity to all applicable standards.  Your declaration must be
   on hard copy and be signed by a responsible officer of the company.
6. Apply the CE mark to your product.

HTH,

Geoff Lane
Cornwall, UK
geoff -at- gjctech -dot- force9 -dot- net