Introduction to CE
Kingsmen ConsultancyServices is one of the largest and leading CE consultants in India. We are transnational ISO certification consultants with clients in Saudi Arabia, Kuwait, Middle East, Europe, Africa, UAE, Qatar, Oman, Dubai, Abu Dhabi, Sharjah etc.. We provide quick, result oriented and easy to implement consultation and training for CE certificate.
The initials “CE” stand for Conformity Europeans, which is French for “European Conformity”. The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive.
Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries.
For the exporter, therefore, Europe, as a whole, has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all of that.
Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.
The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive; referring to Communauté Européen. This literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market, if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.
The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.
How Do You Acquire CE Marking
There is a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.
• Determine if any of the directives apply to your product. If more than one applies, you will have to comply with all of them.
• Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
• Choose the conformity assessment procedure from the options called out by the directive for your product. The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called “Conformity Assessment Procedures”. The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking. Options for products with minimal risk include self-certification, where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product. Options for products with greater risks can require tests, audits or additional certificates from a notified body.
• Select the applicable product standard and test methods for your product and select an independent lab if the product testing is to be done externally.
• Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate, in Europe, a representative to produce technical documentation in a timely fashion when called upon to do so. The directives require, for many products, that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
• Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer’s name, address and signature. The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
• Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.
List of Products needing CE Marking:-
ISO 9001:2000 Quality management systems — Requirements include a document of approximately 30 pages which is available at the national standards organization in each country. Outline contents are as follows:
1. Appliances Burning Gaseous Fuels (AppliGas)
2. Cableway Installations to Carry Persons
3. Low Voltage Electrical Equipment.
4. Construction Products
5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
6. Explosives for Civil Uses
7. Hot Water Boilers
10. Measuring Instruments
11. Medical Devices
12. Active Implantable Medical Devices
13. In Vitro Diagnostic Medical Devices
14. Non-automatic Weighing Instruments
15. Radio Equipment & Telecommunications Terminal Equipment (R & TTE)
16. Personal Protective Equipment (PPE)
17. Simple Pressure Vessels
18. Pressure Equipment
19. Recreational Craft
Here at KCS, we offer a full range of Self Certification for CE Mark compliance and CE management services, for any industry, across the globe. Expert CE Mark Advisers can guide you through the CE compliance maze, assisting you to correctly CE Label your Machinery. Give us a call to see how we can help you.
Delivering safety approvals, CE Mark Compliance, CE Consultancy and Self CE Certification solutions to industry and commerce. Applying the appropriate CE Standards such as EN 12100, EN 60204 and EN 14121 to successfully deploy CE Marking, European Machine Safety Regulations, Machine Guarding advice, risk assessment, hazard analysis and Technical Files, under any type of European CE approvals and CE compliance management systems.
We help many machine manufacturers, distributors and importers of all types of machinery from around the world to CE Mark their machines, products, processes and systems to ensure CE Compliance to the Essential Health & Safety Requirements of the Machinery Directive, Low Voltage Directive, EMC Directive, Pressure Equipment Directive and ATEX Directive and many more areas of European Safety Legislation.
European Machine Safety Regulations
The European Machine Safety Regulations make it an offence to supply machinery or safety component UNLESS IT IS SAFE. At CE Mark Consultancy we can undertake the work to create your Technical Files, or assist you to sell your product in compliance with the appropriate European Machine Safety legislation.
CE Mark Advisory Service
Here at CE Mark Consultancy, we provide a full advisory service and apply our CE Mark Scheme for CE Marking, CE Mark Certification, Machinery, Low Voltage, EMC and Pressure Equipment Directives. Our advisory service provides impartial advice for free and we can guide you through all aspects of CE Compliance. If you have any questions relating to CE Marking, Quality, Environmental or Occupational Health & Safety Systems, give us a call and we will be glad to advise you.
CE Mark Advisors
We have a dedicated team of advisors with a wealth of experience spanning all industry sectors, having considerable knowledge of all aspects of CE Marking, Machine Safety, Risk and Hazard Analysis. Our engineering expertise covers every aspect of safety for all types of machinery.
Typical industry sectors include agriculture, automotive, building trades, ceramics, bottling plants, compression presses (1000 tonne), effluent control, electrical consumer products, food cooking, processing and testing, forestry, ground care (mowing machines), horticultural, machine tools, mechanical handling, medical, packaging, plastic moulding, pressure vessels, testing machinery, printing, specialized press tools, spraying equipment, snow clearing equipment, waste disposal and many more.
What do we offer for CE Certification for your organization?
With a team of highly qualified consultants and trainers having vast industrial experience, KCS assists organizations across the world to implement and achieve CE certification. Our consultation approach is highly professional, time bound and effective, resulting in the ease of implementation and adds value to the business processes of the client’s organization.
We offer CE training, implementation, consultation, gap analysis, documentation, internal audits, pre-assessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization to get the best out of CE management system. Our services are globally accepted, authoritative and benchmarked in the field of CE :
Contact us at email@example.com to get your organization CE certified.