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CE stands for Conformite Europeenne, CE Marking confirms that product is sold with in the European Economic Area comply on safety, health & environmental standards. manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA. CE marking is an integral element of the EU’s legislation, which is mainly control by Directorate-General for Internal market, Industry, Entrepreneurship and SMEs. The CE marking for Restriction of Hazardous Substances.
CE marking is not for all product they have some scope regarding the product which must be assessed on CE marking protocols. There is no comprehensive list of the products that require CE marking. Therefore, it is the manufacturer’s responsibility to determine if a product requires CE marking. The “New Approach Directives” are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU. In some cases Europe based importers, distributors and customers demands from their global supply chain for the CE Marking.
During the Covid-19 pandemic, mostly companies are manufacturing the PPEs (Surgical gowns, Surgical mask, Surgical gloves, Hand Sanitizer, Surface Cleaners) in all over the world to meet market demand and export their products to Europe. The companies in Europe are demanding the products with CE marking certification to meet their regulatory requirements.
The first step is to identify whether intended product can be CE marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives. There are two ways of CE Marking one through notified body and other is unnotified body and it also depends of customer’s requirements according to the intended use of product.
When all the requirements have been established then you need evidence that the product meet the important requirements of the directives. it usually involves some assessment / testing to ensuring the requirements of applicable standards. Technical documentation relating to the product or range of products need to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.
Charges of CE Marking can not be flat or same for every organization, please contact us in this regard.
Quality Systems is working with the team of qualified and experienced consultants and trainers having vast industrial experience, most of our consultants are also lead auditors who are aware to the expectations of auditors from your management system during the audit. Quality systems is assisting across the world to implement and achieve the CE Marking outstanding results. Our consultation methodology is highly professional, time bound and effective and we always add value to the business process of the client’s organization.
Our CE Marking complete package comprised on following segments such as consultation, gap analysis, documentation, and development of technical file. We provide the most recognized CE Marking certificate by unnotified bodies or notified bodies depending on the requirement.