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Product Certification

CE

Introduction to CE

Qualitas is one of the largest and leading CE consultants in India. As a transnational ISO certification consultancy, we serve clients in India, the USA, the UK, Saudi Arabia, Kuwait, the Middle East, Europe, Africa, Australia, Singapore, Hong Kong, the UAE, Qatar, Oman, Russia, and beyond. We offer quick, result-oriented, and easy-to-implement consultation and training services for CE certification

The initials “CE” stand for Conformité Européenne, French for "European Conformity." The CE Mark, affixed to a product or its packaging, serves as proof that the product meets the requirements of harmonized European standards or directives.

Europe presents a highly competitive yet lucrative market that is more accessible than ever. However, many Indian exporters, particularly small and medium enterprises, shy away due to the seemingly complex and technical entry requirements. Indian manufacturers who have successfully entered the European market understand the significant value in investing the time and effort to comprehend its systems. With approximately 450 million affluent consumers across more than 25 countries, the European market is one of the largest globally.

For exporters, Europe has become a more straightforward market thanks to harmonized technical requirements. Before the European Union was established, individual countries enforced their own standards and conformity assessment procedures, creating barriers for exporters. The unification of these nations into the European Union, along with the harmonization of laws, standards, and conformity procedures, eliminated many of these challenges

ISO 9001 Certification is extensively utilized in Europe as a benchmark for product acceptance and manufacturer credibility. However, manufacturers must not assume that having a quality system such as ISO 9001 automatically ensures CE compliance. The relevant New Approach Directive(s) will specify the correct conformity assessment process required

The CE Mark, affixed to a product or its packaging, signifies that the product complies with essential health and safety requirements under applicable directives. It acts as a "passport" for products to be sold freely within the European internal market. While not a quality mark or consumer label, it serves as a visible confirmation of compliance for regulatory authorities

Steps to Acquire CE Marking

To obtain CE marking, manufacturers must follow these steps:

  • Identify applicable directives for the product. If multiple directives apply, all must be followed.
  • Ensure the product design and manufacturing comply with essential requirements under the relevant directives.
  • Choose the appropriate conformity assessment procedure based on the directive's classification of product risk. This may range from self-certification for low-risk products to requiring third-party testing or certification for higher-risk products.
  • Determine the applicable product standards and test methods, and select an independent lab if external testing is required.
  • Establish an authorized representative in the European Union to handle regulatory affairs and maintain technical documentation, as required by certain directives.
  • Prepare a Declaration of Conformity listing the applicable directives, standards, product details, manufacturer information, and authorized signatures.
  • Affix the CE Mark to the product following specific rules regarding its size, placement, and accompanying documentation..
Products Requiring CE Marking:

Some products requiring CE Marking include:

  • Appliances burning gaseous fuels
  • Medical devices (including active implantable and in vitro devices)
  • Personal protective equipment (PPE)
  • Machinery.
  • Pressure equipment
  • Low-voltage electrical equipment
  • Toys
  • Recreational craft
  • And more
CE Certification with Qualitas Elit

At Qualitas Elit, we provide comprehensive CE certification services globally. Our expert CE consultants simplify the certification process, guiding you through compliance requirements, technical documentation, and CE labeling.

Our CE services include:

  • Training and implementation
  • Gap analysis and documentation
  • Internal and pre-assessment audits
  • Certification audit facilitation with leading certification bodies
  • Post-certification support to ensure continued compliance

Our highly qualified team of consultants and trainers, with vast industry experience, ensures a smooth certification process while adding value to your organization’s business operations.

Contact us at [email protected] to learn how we can assist your organization in achieving CE certification.