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Product Certifications :: |
OVERVIEW |
The
CE Mark ('Trade Passport to Europe') is a visible declaration by the
manufacturer (or his representative, importer, etc.) that the
equipment, which is marked, complies with all the requirements of all
the applicable directives. This mark allows manufacturers and exporters
to circulate products freely within the 15 European Union (EU) members.
Having ensured that the equipment does indeed meet all these
requirements (including all the administrative requirements involved in
being able to demonstrate compliance), the CE Mark may then be affixed
and the product released. The letters, "CE", indicate that the
manufacturer has undertaken all assessment procedures required for the
product. The CE mark is not a quality mark and does not indicate
conformity to a standard; rather, it indicates conformity to the legal
requirements of the EU Directives
The
"CE" mark is now mandatory for regulated products sold in the European
Union. This applies to prototypes and commercial freebies. One of the
objectives of the EU is the realization of a single European market in
which products can be traded freely without any trade restrictions. The
adoption of the CE Marking offers manufacturers and exporters
advantages by eliminating differing national product regulations among
members of the EU and the signatory states of the European Economic
Area Agreement. |
Who is it relevant to? |
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you manufacture or import a product which falls within the scope of one
or more of the New Approach Directives and wish to place your product
on the market in any of the members states of the European Economic
Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives. |
STEPS TO CE COMPLIANCE |
The
New Approach Directives will provide a range of compliance routes for
your product and show you, usually in a modular format, the available
routes to compliance. IQS helps to decide you which is the best
fit for your company set up and follow the suitable route. In many
cases the compliance route will require you to use a Notified Body to
assist with your certification. The essential requirements of the New
Approach Directives differ from directive to directive and product to
product.
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Identify the Directive(s) that are applicable to your product |
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Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing,
inspection or quality system assessment from a Notified Body or a
combination of these. The conformity assessment procedure will differ
depending on your product and the Directive in respect of which you
will be CE marking. IQS helps to make choice about which procedure to take, |
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Identify if there are any Harmonised European Standards applicable to your product.
These are not always mandatory for manufacturers although there is a
presumption that conformity to these standards will give conformity
with the relevant part of the Directive. Whenever possible or
appropriate, manufacturers should follow harmonised standards. |
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Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports. |
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Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. |
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Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. |
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Prepare the Declaration of Conformity and the required supporting evidence.
The Declaration of Conformity along with the Technical Documentation
should be available to Competent Authorities (EU Members) upon request. |
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Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements. |
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Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive. |
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List of New Approach directives for CE Marking
Directive |
Subject (short title of directive) |
2006/95/EEC |
Low Voltage Equipment (LVD) |
87/404/EEC |
Simple Pressure Vessels |
88/378/EEC |
Toys Safety |
89/106/EEC |
Construction Products |
89/336/EEC |
Electromagnetic Compatibility (EMC) |
89/686/EEC |
Personal Protective Equipment (PPE) |
90/384/EEC |
Non-Automatic Weighing Instruments |
90/385/EEC |
Medical Devices - Active Implantable |
90/396/EEC |
Appliances Burning Gaseous Fuels |
92/42/EEC |
New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements) |
93/15/EEC |
Explosives for Civil Uses |
93/42/EEC |
Medical Devices - General (MDD) |
94/9/EC |
Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX) |
94/25/EC |
Recreational Craft |
94/62/EC |
Packaging and Packaging Waste |
95/16/EC |
Lifts |
97/23/EC |
Pressure Equipment (PED) |
98/37/EC |
Machinery Safety |
98/79/EC |
Medical Devices - In Vitro Diagnostic (IVD) |
99/5/EC |
Radio Equipment and Telecommunications Terminal Equipment |
00/9/EC |
Cableway Installations designed to Carry Persons |
04/22/EC |
Measuring Instruments |
BIS/ISI Marking
Certification for ISI mark is given by the Bureau of Indian Standards (BIS), the National Standards Body of India, involved in the development of technical standards (popularly known as Indian Standards), product quality and management system certifications and consumer affairs. It resolves to be the leader in all matters concerning Standardization, Certification and Quality.
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The applicant has the option to choose any of the following two procedures for grant of BIS licence:
i)Normal Procedure – In the normal procedure, the applicant is required to submit the filled in application along with required documents and requisite fee to the nearest BIS branch office. Subsequently, after recording of the application, a preliminary factory evaluation is carried out by BIS officer to ascertain the capability of the applicant/manufacturer to produce goods according to the relevant Indian Standard and to verify the availability of complete testing facility and competent technical personnel. Samples are tested in the factory and also drawn for independent testing. Grant of licence is considered by BIS provided the samples pass during independent testing, preliminary evaluation is satisfactory and the applicant agrees to operate the defined Scheme of Testing & Inspection and pay the prescribed marking fee.
ii) Simplified Procedure – In the simplified procedure, applicant is required to furnish the test report(s) of the sample(s) got tested by him in the BIS approved laboratories, along with the application. If the test report(s) and other documents are found satisfactory, a verification visit is carried out by BIS. The licence is granted thereafter if the verification report is found satisfactory. The applicant also has the option to get the documents and other details as specified in the application, certified by a Chartered Engineer and submit the same to BIS.
Note 1: Simplified procedure is available for all products except certain items under mandatory certification like gas cylinders, valves, regulators, cement, etc.
Note 2: If any licence granted as per simplified procedure is cancelled in the event of failure of verification samples, the fresh application shall only be considered as per normal procedure.
Note 3: All India first licence for any product shall be granted as per normal procedure only.
Note 4: There is a separate scheme for Foreign Manufacturers and Indian Importers
How IQS can help?
Our technical experts offer one of the best services as to all the companies irrespective of their sizes and nature.
IQS understand that each organization or person is unique. Our Solutions are comprehensive and will be customized to meet your specific needs.
We provide with ISI certification services in which we help you achieve ISI certificate by improving your management system and thereby your quality standards. |
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