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A CoC or EC Certificate of Conformity is equal to a declaration of the conformity with the type approval of EC. It is produced to ensure the free movement of equipment within the European Union, specifically for equipment that is subject to homologation or registration.
The Declaration of Conformity contains a description of the product, the directive(s) and regulation(s) applied, the product category for each directive or regulation, the module chosen, and the name and registration number of the notified body involved in certification procedures (models).
An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [ 7 ] European ‘Blue Guide" [ 8 ] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.
Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined regulations, but also to provide an official certification mark or a declaration of conformity. [4] [5]
an agreed system of attestation of conformity for each product family; a framework of notified bodies; the CE marking of products. [4] The Directive did not aim to harmonise regulations. Member States and public and private sector procurers were free to set their own requirements on the performance of works and therefore products.
Following type approval, a vehicle is issued with a Certificate of Conformity which includes a COC number. This number may look like: e13*2001/116*0260 where e13 is the UNECE state number (in this case Luxembourg), 2001/116 is the EC/EU directive name.
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
Records must be kept for all equipment. All equipment manufactured should be given a “birth certificate”. This should prove that when first made, it complied with any requirement. In Europe today, this document would normally be an EC Declaration of conformity plus a manufacturers certificate if called for by the standard worked to.