Europe 92: Is Quality System Registration Enough?


Berg, Douglas L.; Harral, William M.   (1992, ASQC)   Powertrain Div. - General Motors, Ypsilanti, MI

Annual Quality Congress, Nashville TN    Vol. 46    No. 0
QICID: 9752    May 1992    pp. 2-8
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Member $5.00

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Article Abstract

In order to avoid loss of time, money, and market opportunities, companies interested in exporting to the European Community (EC) must understand how to comply with "essential requirements." These "essential requirements"-- based on health, safety, or environmental concerns--may include, but are not limited to, quality systems registration, such as the International Standards Organization (ISO) 9000 series of quality standards. Quality systems registration is often not sufficient or necessary to export a product or service to the EC. Companies need to understand the EC's organizational structure and its regulatory process. The EC allows companies from nonmember states to market and to sell in the Community if a particular member state's requirements or the general community requirements are met. At any time, companies can be challenged to demonstrate compliance to requirements through testing, certification, and registration. Verification of such testing may also be expected. The same approach is utilized for both regulated and nonregulated products, with the exception that the testing, certification, and registration of regulated products is restricted to "notified bodies" within the EC. It is not clear that all regulated products need to undergo quality systems registration. Older legislation already covers some products; others are to be governed by the EC's "global" approach, which features a modular conformance assessment ranging from simple manufacturer conformance declarations to "full quality assurance" covering design and production with notified bodies and third party registration. The article directs readers to several sources which offer information about specific products and markets, including the ISO and the EC itself.


Globalization,ISO 9000,Marketing,Q90 series,Quality assurance (QA)

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