Declaration of conformity important document with CE marked products

The declaration of conformity, granted by the manufacturer of a CE marked product, is one of the cornerstones on which the legitimatly of the applied CE marking rests. Therefore there is a standard available in which requirements about these declarations are set.  This norm, the ISO 17050-1: Conformity assessment-supplier’s declaration of conformity, Part 1: general requirement, goes into this matter extensively.

It is important that the conformity of the product, with one or more specific requirements such as a European guideline, should be stated unambiguously. The purpose of this statement is to give assurance about the conformity regarding the specific requirements of the product and to make clear who is responsible for this declaration of conformity and who could make a statement about it when necessary.

The declaration of conformity must be based upon the results of an apposite type of research and it must use relevant product standards, guidelines and other normative documents.

What are the elements of a declaration of conformity?

The originator of a declaration of conformity has to ensure that the declaration contains sufficient information to inform the recipient about the editor (which is the manufacturer), about the subject (the product or object) of the declaration, about the used guidelines, standards or other specific requirements which are used to declare the conformity and the responsible official (on behalf of the manufacturer) has to sign the statement.

At least the following information must be given:

1. Unique identification of the declaration of conformity;

2. Name and address of the publisher of the declaration;

3. Identification of the subject of the declaration (e.g. the model or product number, lot or batch number);

4. The statement that there is conformity;

5. A complete list of guidelines, standards and other specific requirements;

6. Place and date when issued;

7. Name and signature of an authorized person, acting on the behalf of the publisher;

8. Applicable restrictions on the validity of the declaration of conformity;

9. Necessary additional information such as the name and address of the compliance assessment body, including an indication of report or certificate number and date of issuance.

Incorrect declaration of conformity is in conflict with the law

Furthermore, the publisher of the declaration of conformity has to use specific procedures to apply to the conformity of the product to guarantee the declaration.  Also in cases where the design of the product is modified, the production methods are changed, or the product specifications or other requirements are altered or when the issuing organization gets a new owner or management team.

This means that the declaration of conformity is not a paper tiger but a legal statement. And it is clear that when this declaration is not based upon reality it is conflict with the law. Customers, regulators or other stakeholders can address manufactures. Recipients of CE marked products do well to always retrieve and store their declarations of conformity. While manufacturers must ensure that the claims contained in the declaration are correct, also with modifications of the product or within the production or organization.