EC testing and certification procedures: how will they work? - European Community - European Community '92 Update

Business America, Feb 25, 1991 by Mary Saunders

EC Testing and Certification Procedures: How Will They Work?

The harmonization of product safety certification requirements in the European Community is an important development for U.S. manufacturers. Harmonized procedures can reduce the need for design and production changes, reduce costs, and expand market opportunities. Manufacturers need to become familiar with how product certification procedures will work in the new EC market, and with the specific procedures that are relevant to their product area, so that they can take full advantage of new market opportunities in the EC market after 1992.

The EC's Global Approach to testing and certification for product safety is intended to provide producers with one set of procedures for certifying product compliance with EC health, safety, and environmental requirements for products ranging from toys to machinery to medical devices (see box on next page). EC legislation specifies various means by which manufacturers can certify product conformance. Options include manufacturer self-declaration of conformity, third-party testing, quality assurance audit, and/or full type approval by a body authorized by an EC member state and recognized by the EC Commission. A "CE" mark on the product signifies that all legal requirements have been met.

Many manufacturers will have to meet the requirements of more than one directive in certifying product conformity. Take the situation for a manufacturer of commercial air-conditioning equipment, for example. Safety requirements for this equipment are covered under three separate directives--machine safety, pressure vessels, and construction products (which covers equipment installed in buildings as well as building materials themselves). Product certification would involve some combination of in-house safety testing, audit of the manufacturer's production quality assurance system, and type examination by a third-party certifier (for any pressure vessel component).

Reference to harmonized European standards relevant to EC legal safety requirements provides manufacturers the simplest route to product certification. These standards are now being developed by regional standards organizations, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI). Manufacturers are free to refer to other standards in certifying compliance, but the certification process will be more complicated. The Community views European standards as critical to the effectiveness of their planned testing and certification system; so much so that implementation of at least one directive (pressure vessels) has been postponed for two years because standards have not yet been completed.

Quality System Registration--A Requirement?

U.S. manufacturers have heard reports about the need to go beyond product certification to documentation that they operate an approved in-house quality assurance system in order to be able to place their products on the market in the EC. This is not a blanket requirement for all products. However, for producers of medical devices, construction products, industrial safety equipment, telecommunications terminal equipment, gas appliances, and commercial scales, approval of a manufacturers' quality assurance (QA) system is a key component of EC legal requirements for safety certification.

General guidelines for establishing a QA system are found in the European equivalent of International Standards Organization (ISO) 9000 standards (the EN 29000 series). In some areas, European standards organizations are developing additional guidelines for the application of these generic standards to specific product sectors, such as medical devices. With the implementation of EC directives, only listed approval bodies will be able to register QA systems established to meet regulatory requirements. U.S. quality systems auditors may be qualified to perform these registrations in the future, but their status is unclear at the present time.

Who Can Certify?

All EC product safety directives provide for some third-party role in testing or certification. For six directives already adopted this is mandatory. EC member states are responsible for determining the competence of test labs and certification bodies that apply for recognition under the EC system. Approval is at the member state level, according to recognized accreditation procedures based on the EN 45000 series of standards. Member states notify their selections--thus the term "notified" bodies--by task and by directive to the EC Commission, which has the right to request information from member states on the competence of bodies and can require verification of qualifications.

On their own responsibility, notified bodies in the EC can subcontract specific activities to extend their ability to perform. Subcontractors can be located outside of the EC. Conditions and limits have not been fully specified yet, but subcontracting of testing activities has been specifically permitted by the EC Council of Ministers. The general guidelines for subcontracting indicated by the EC Commission are that notified bodies will need to hold subcontractors to EN 45000 standards, including: that subcontractors must comply with all requirements to maintain records; that subcontractors must test to the same standards as the notified body; and that notified bodies remain responsible for any certification activity. Still up in the air are important issues such as whether any or all aspects of QA system audits can be subcontracted, how widely EC notified bodies will exercise their subcontracting capabilities, and whether subcontracting arrangements will give U.S.-based manufacturers sufficient low-cost access to the EC market.