Quality Glossary Definition: Conformitè Europëenne Mark (CE Mark)
European Union (EU) conformity mark for regulating the goods sold within its borders. The mark represents a manufacturer’s declaration that products comply with EU New Approach Directives. These directives apply to any country that sells products within the EU.
A CE mark is a symbol that must be affixed to many products before they can be sold on the European market. The mark indicates that a product …
- Fulfills the requirements of relevant European product directives.
- Meets all the requirements of the relevant recognized European harmonized performance and safety standards.
- Is fit for its purpose and will not endanger lives or property.
The presence of CE marking further indicates that appropriate technical documentation supporting the use of the mark is available and can be provided by the manufacturer, importer, or person responsible for placing the product on the EU market upon request.
Self-declaration vs. certification
CE marking does not provide any specific information to the consumer. It is not a quality assurance declaration, it does not show evidence of third-party testing, and it should not be confused with any independent certification mark of the type issued by international or European notified test bodies.
Certain directives include an option for the responsible organization to provide a declaration of conformity stating that a product fulfills the requirements of the applicable directives, but, if challenged, appropriate evidence must be supplied to support the self-declaration claim. Other directives, particularly those pertaining to products affecting health and/or safety, such as pressure vessels, will require a specific certificate from a notified body.
Meeting EU requirements and conforming to directives
Affixing a CE mark to a product is considered a means to certify for authorities within the EU member states that the product meets all appropriate EU requirements.
There is an EU requirement that products not in conformity with the provisions of the directives are not allowed to circulate in the territories of the member states; appropriate action should be taken to remove these products from sale and use within the specific state. One example is the recent import of toys from China to the UK which, when examined, were found to contain a high level of poisonous toxins that endanger life.
The importer and/or manufacturer must take steps to comply with safety provisions, produce the appropriate records, and decide on the necessary procedures to maintain production in conformity with directives. The CE marking must be affixed to demonstrate conformity with the provisions of the directives.
Specific directives have comprehensive safety objectives, but they leave the manufacturer to make decisions on how these may be achieved.
Where more than one CE marking directive pertains to a product and a transitional period allows the manufacturer a choice of which to apply, the marking indicates conformity only with those directives applied by the manufacturer. In this case the directives that have been applied must be identified in the documents or notices accompanying the product. Where the manufacturer does not list those directives that have been applied, the authorities will assume that a declaration of conformity is available for all applicable directives.
The bottom line in demonstrating conformity
Any organization manufacturing or selling products in the EU should be aware of its obligations when it comes to demonstrating conformity to requirements and directives:
The CE mark must be affixed to demonstrate conformity with the provisions of the directives.
- In the event of a challenge, a report from a notified body may be submitted showing conformity of the equipment. This allows the manufacturer working with a notified body to show conformity with the safety objectives.
References for further reading
Contributed by Adel Shakour, P. Eng, ASQ CQA, ASQ CQE
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