Conformity Assessment: What it is and How it Works in Practice
The European Commission is determined to help ensure that unsafe or otherwise non-compliant products and services are not sold or offered on the EU market. As a manufacturer, you’re only required to place your product on the EU market after it has satisfied all the applicable requirements. Standards establish requirements, and there should be efficient communication between the supplier and the consumer that the product or service at hand conforms to a standard. Read on to learn more about what conformity assessment is, why it’s important, and how it works in practice.
What is the Conformity Assessment?
According to the International Electrotechnical Commission, Conformity Assessment (CA) refers to any activity that results in examining a product or other object with the aim to determine whether it corresponds to the requirements contained in a particular specification. A specification is a technical description that outlines the characteristics that must be fulfilled by an object, in this case, products, bodies, processes, people, or systems. This assessment doesn’t limit or classify the activity in any way.
Why Carry Out Conformity Assessment?
The main objectives of carrying out conformity assessment procedure include:
● To ensure and enhance the confidence of consumers, manufacturers, and public authorities concerning the conformity of products.
● To demonstrate that a product or service being introduced on the market fully complies with all the relevant legislative requirements.
How it Works in Practice
CA encompasses the areas of inspection, surveillance, testing, auditing, registration, certification, and accreditation. There are two main approaches to CA; manufacturer’s self-declaration and third-party certification. Self-declaration is the most common approach where the manufacturer tests their product and declare that it meets the standards, either by labelling or marking, as per the standards. The manufacturer should produce a written declaration of conformity (more details on this below).
Where self-declaration will not satisfy the regulatory requirements or market demand, the manufacturer will have to seek third-party certification. This involves an independent organisation conducting ongoing tests on a product, to determine whether it meets all the performance requirements of the relevant standard. This body may also assess the quality systems of the manufacturer to ensure efficient design and operation of the internal production controls, which will guarantee the production of products that meet the standard’s requirements.
Once the testing is done and all conditions are met, whether via self-declaration or third-party certification, the manufacturer can then use the recognised EU certification mark, the CE mark. Therefore, when shopping for products for different tasks, ensure to go for CE marked fabrications, because they have been designed and manufactured to meet the conditions of products on the EU market.
Declaration of Conformity
The manufacturer or authorised representative is required to come up with a declaration of conformity (DoC) as part of the conformity assessment. The DoC should contain all information regarding:
● The product,
● The manufacturer or authorised representative,
● The notified body if applicable,
● The legislation according to which it’s issued, and
● A reference to the harmonised standards and any normative documents, where applicable.