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November/December 2009
Feature

Understanding Conformity Assessment: Four Principles

Intertek, Underwriters Laboratories, the Canadian Standards Association and the American Council of Independent Laboratories collaborated on a statement in which they outline four principles of conformity assessment.

Conformity assessment is defined by ISO/IEC 17000, Conformity Assessment — Vocabulary and General Principles, as “any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.”

The statement principles are outlined and discussed as follows.

Principle Number One: Any basic conformity assessment “activity,” or combination of conformity assessment “activities,” must deliver confidence that relevant requirements are fulfilled.

For example a consumer must have confidence that the software he purchased will operate reliably on his computer. The Food and Drug Administration must have confidence that a medical device will operate reliably and will not cause harm to the patient.

Principle Number Two: The “parties” to the conformity assessment transaction determine the confidence level required for a specific product or service.

The three basic “parties” to the transaction are defined as first, second or third party. ... Each has a responsibility in the types of conformity assessment activities necessary for a particular product or service. However, when there are safety, health, and environmental risks and/or performance requirements for a particular product, second party ... demands take precedence.

Principle Number Three: Non-regulatory government agencies should be “method-neutral” in their approach to the conformity of products.

In the United States, and around the world, government agencies come in two basic types: regulatory and non-regulatory. Examples of regulatory agencies in the U.S. are the Federal Communications Commission, the Food and Drug Administration and the Occupational Safety and Health Administration. All of these agencies have a regulatory responsibility in determining the particular types of conformity assessment activities that apply to a particular product based on their fundamental mission, which in this regard, is to protect the public from nonconforming products.

Non-regulatory agencies, such as the [U.S.] Department of Commerce, have a very different mission. In this case, it is facilitation of trade, but it has no regulatory authority to protect the public from non-conforming products. We believe that the current DOC “standards-neutral” approach should be applied to conformity assessment. In other words, non-regulatory federal agencies should not favor one conformity assessment approach over another. Their position regarding conformity assessment should be “method-neutral.” They should defer to the marketplace and appropriate regulatory agencies in determining the rigor and independence of conformity assessment needed for a particular product or service.

Principle Number Four: The rigor and independence needed in the conformity assessment activity is directly proportional to the risk associated to the use of a particular product.

No one would argue that third party certification and quality systems registration are necessarily needed for a product such as a lead pencil. However, the risks associated with a machine tool would dictate the need for greater rigor and independence.

The “method-neutral” principle, combined with the other three principles, and applied consistently around the world, will help eliminate artificial non-tariff trade barriers that prevent market access for products that improve economic growth and performance.

 

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