The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
The Global Approach
Also refers to the Modular Approach to conformity, the Global Approach specifies certain "Conformity Assessment Modules" which Directives refer to. This assures a uniform conformity procedure. There are eight conformity assessment modules Module A to H and are in the increasing order of risk or hazards of the product. The Directive (s) in question decide as to which module the manufacturer shall apply depending upon product classification.
The "New Approach" to conformity enables manufacturers to use what is called as "SELF DECLARATION" where the manufacturer himself declares conformity by signing the "Declaration of Conformity (DOC)" and then affixes the CE Mark on his product.
The following simple steps are involved
STEP 1: Identify Applicable "DIRECTIVES"
STEP2 : Identify Applicable "Conformity Assessment Module"
Although CE Marking follows the Self Declaration principle, depending upon product complexity and risk to human life, various conformity assessment module are prescribed:-
Module 'A' (Internal Production control).
Applicable for products falling under EMC and Low Voltage Directives. Manufacturer tests the product from third party. After compliance with the tests, his production process ensures continued conformance. He maintains "Technical Documentation" as a proof of compliance. There is No mandatory involvement of European Lab (i.e. Notified Body).
Module 'B' to 'H'
Mandatory involvement of European Lab is required which issues "Type Examination Certificate", certifies documentation (called "Technical Construction File"(TCF) and carries out inspections.
STEP3 : Identify Applicable "Standard"
STEP4 : Test one sample of the product. Either yourself or from test lab.
STEP5 : Compile "Technical Documentation"
STEP 6 : Sign the EC "Declaration of Conformity"
STEP 7 : Affix "CE Mark" on the product.
Declaration of Conformity
The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE mark on a product the manufacturer must draw up a Declaration of Conformity (DoC) in which the manufacturer attests conformity with all relevant NADs and takes sole legal responsibility. In some instances a NAD may require a Notified Body to issue a Certificate of Conformity in order to verify performance of the product or constancy of the production process (Factory Production Control) for example.
The DoC must include: manufacturer's details (name and address etc); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.
Mutual recognition of conformity assessment
There are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel. Consequently the CE mark is now found on many products from these countries.
Turkey (which is not a member of the EEA) also requires products to show CE marking as affirmations of conformity.
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