NIST SP 951
A Guide to EU Standards and Conformity Assessment

Technical Harmonization: Conformity Assessment

Conformity assessment is defined by the International Organization for Standardization/International Electrotechnical Commission Guide 2: 1996 as:

"any activity concerned with determining directly or indirectly that relevant requirements are fulfilled."

Typical examples of conformity assessment activities are sampling, testing and inspection, evaluation, verification and assurance of conformity (supplier's declaration), certification, registration, accreditation, and approval as well as their combinations.

Conformity assessment may also be the process by which it is determined that a product's design meets a specification or standard.

Conformity assessment may vary in levels of difficulty and complexity, depending on the level of risk associated with the product. If a Harmonized Standard is used to meet an essential requirement of a New Approach Directive, and if the risk of injury is low (See Risk Assessment), no third party conformity assessment procedure is required. (This is true regardless of the nationality of the manufacturer.) A manufacturer or supplier may declare, after performing the necessary product evaluations (through a Declaration of Conformity), that the product meets the essential requirements of a directive. As the risk of injury increases, the level of complexity of the conformity assessment process (and the cost) increases with it. The applicable directive will be the guide to the level of risk involved and the methods of conformity assessment that may be employed.

Harmonization: The Global Approach

In Europe, the point of the New Approach Directives was to eliminate differences between national laws, thereby eliminating barriers to trade between the Member States. But differences in national standards and testing and certification procedures were the root causes of barriers to trade, and it followed that a new, integrated scheme for technical harmonization had to be implemented as well. The new scheme was embodied in two Decisions: (1) the Module Decision, and (2) the regulation on CE Marking. The policy was called the Global Approach. It incorporated conformity assessment procedures directly into the New Approach Directives.

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Technology Services, Standards Services Division, Global Standards and Information Group Contact: maureen.breitenberg@nist.gov A Guide to EU Standards and Conformity Assessment, NIST SP 951

Date Created: 05/31/00 Last Modified: 05/31/00