Page 17 - CE Marking

PART 4 CE-Marking
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I n Parts 1, 2 and 3 of this series, we looked at the first three steps
you have to take as a manufacturer to obtain the CE-mark for
your product(s). We started with the first two steps: determining
the product’s application and establishing which EU directives apply to
it. Then came step 3: the technical aspects of the so called conformity
assessment procedure. This means finding out and deciding how
to meet the requirements and carrying out a risk analysis. In this
article we’ll look at the next three steps in the conformity assessment
procedure: the administrative requirements.
Each New Approach directive describes the range and contents of
the conformity assessment procedure. If you do what it says, you
may assume your product and production process are safe. Because
different products involve different risks, the conformity assessment
is divided into modules that cover all possible procedures and risk
levels. Please note that each directive has its own specific elements.
For example, certain directives provide modules based on quality
assurance techniques derived from the EN ISO 9000 (2001) series
of standards. If you’re aware of this, you can fulfil the directives’
requirements and your clients’ wishes at the same time. Also, it allows
you to benefit from your investment in quality systems. However, it
goes beyond the scope of this article to include all these issues.
For more specific information on each directive, we advise you to
consult the CBI’s online AccessGuide database. According to the
New Approach directives, then, you have certain administrative
obligations as a manufacturer seeking to obtain CE-marking for your
products. Basically, there are three administrative steps to be taken:
1) drawing up technical documentation; 2) composing a user manual;
and 3) composing an EC declaration of conformity. Each directive may
stipulate slightly different requirements. But let’s take a general look
at these three steps.
PART 4 : KEEPING UP THE ADMIN