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CE Marking

 
CE Marking
 
CE Mark is required for certain exports to the European Market. These are made mandatory by Directives released by the European Union. The products requiring CE mark are: (this is not an exhaustive list)
 

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.

CE Marking Procedure

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.

 
DIRECTIVE No. DIRECTIVE NAME
73/23/EEC Low Voltage Equipment (LVD)
87/404/EEC Simple Pressure Vessels
88/378/EEC Toys
89/106/EEC Construction Products (CPD)
89/336/EEC
92/31/EEC
Electromagnetic Compatibility (EMC)
89/392/EEC
REPEALED BY
98/37/EC
Machinery
89/686/EEC
93/95/EEC
96/58/EC
Personal Protective Equipment (PPE)
90/384/EEC Non-automatic Weighing Instruments
90/385/EEC Active Implantable Medical Devices (AIMD)
90/396/EEC Gas Appliances
92/42/EEC Efficiency of Liquid or Gaseous Fuelled Hot Water Boilers
93/15/EEC Explosives for Civil uses
93/42/EEC Medical Devices (MDD)
93/97/EEC
REPEALED BY
98/13/EC
Satellite Earth Station Equipment
94/9/EC Equipment in Potentially Explosive Atmospheres -"ATEX"
94/25/EC Recreational Craft
94/62/EC Packaging and Packaging Waste
95/16/EC Lifts
96/57/EC Energy Efficiency: Household Refrigerators & Freezers
98/79/EC In Vitro Diagnostic Medical Devices
97/23/EC Pressure Equipment (PED)
98/37/EC Machinery
1999/5/EC Radio & Telecom Terminal Equipment
2000/9/EC Cableway Installations for Passengers
2000/14/EC Noise Emission in the environment by equipment for use outdoors
 
Process of CE Marking ( self-certification mode )

1. Study which directive/s is applicable

2. Determine which standard/s are applicable

3. Test your product to ascertain if it complies

4. Make a test report

5. Make Technical Construction File:

Technical documentation - The manufacturer must draw up a technical Construction file (TCF). The technical documentation is intended to provide information on the design, manufacture and operation of the product. 

6. Prepare a technical file documenting compliance with the applicable requirements.

7. Prepare and sign a manufacturer’s self-declaration of conformity.

8. Apply the CE Mark to the product.

9. Ship the product to the European Union with a copy of the signed

declaration of conformity, Instruction booklet for safe use and maintenance.

 
Process of CE Marking ( third party-certification mode )

The steps essentially remain the same.

In this case, the test must be witnessed by a Notified Body.

The test report will be made by the Testing Laboratory, and declaration will be made by the Notified Body.

The CE Mark will carry a number linking to the Notified Body.
 
How to reproduce the CE Mark ?

The CE mark is covered by Council Decision 93/465/EC. Annex B(d) gives these guidelines:

1. The CE conformity marking must consist of the initials 'CE' taking the following form:

CE Mark

If the CE conformity marking is reduced or enlarged the proportions given in the above
graduated drawing must be respected.

2. Where the directive concerned does not impose specific dimensions, the CE marking
must have a height of at least 5 mm.

3. The CE marking must be affixed to the product or to its data plate. However, where
this is not possible or not warranted on account of the nature of the product, it  must
be affixed to the packaging, if any, and to the accompanying  documents,  where  the
directive concerned provides for such documents.

4. The CE marking must be affixed visibly, legibly and indelibly.
 
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