ISO 9000 and marketing in Europe: should U.S. manufacturers be concerned? - European quality system standards

Business America, April 20, 1992 by Mary Saunders

Many myths have been perpetuated about the role of quality system registration and U.S. manufacturer access to the European market after 1992. The following discussion is reprinted from Europe Now, a quarterly Commerce Department newsletter that tracks developments in the European Community and describes for U.S. firms the opportunities and challenges in the market.

Myth No. 1

If my company is not registere as complying with ISO 9000 quality system standards we will not be able to sell our products in the EC after 1992.

ISO 9000 registration is not a legal requirement for access to the EC market. In EC product safety legislation, registration to one of the European standards equivalent to the ISO 9000 series - EN 290013-3 - is cited as component of the product certification process for gas appliances, construction product, commercial scales, telecommunications terminal equipment, and certain classes of personal protective equipment and medical devices. Planned EC legislation for pressure equipment, recreational craft, cable ways, and lifting equipment for persons also references EN 29000 compliance. For most of these regulated products, ISO 9000 registration is an alternative for product certification, not an absolute requirement. In fact, as cited in most EC legislation, quality system registration is neither mandatory - there are other paths to product certification - nor is it a stand-alone procedure. Manufacturer compliance with either EN 29002 or 29003 is usually combined with product-type testing at the design stage for full certification to EC legal requirements. Manufacturers need to review relevant EC product safety directives for specific applicable to their product area.

Outside of regulated product areas, the importance of ISO 9000 registration as a competitive market tool in the EC varies from sector to sector. In some sectors, European companies may require suppliers to attest that they have an approved quality system in place as a condition for purchase. This could be specified in any business contract. ISO 9000 registration may also serve as a means of differentiating different "classes" of suppliers, particularly in high-tech areas, where high product reliability is crucial. In other words, if two suppliers are competing for the same contract, the one with ISO 9000 registration may have a competitive edge with some buyers. Sector and product areas where purchasers are more likely to generate pressure for ISO 9000 registration include aerospace, autos, electronic components, measuring and testing instruments, and so on. ISO 9000 registration may also be a competitive factor in product areas where safety or liability are concerns.

Myth No. 2

I must certify my product as being in compliance with ISO 9000 standards.

The ISO 9000 standards do not apply to specific products. They are generic system standards that enable a comply, through a mix of internal and external audits, to provide assurance that it has a quality system in place that will enable it to meet its published quality standard. What is produced is essentially immaterial to the audit process. ISO 9000 registration is, in effect, a certification of the product process only. Therefore, registration to ISO 9000 is not indicated on the product itself, but can only appear on the product literature or advertising.

Manufacturers should be aware that ISO 9000 does apply to purchasing, assessment of subcontractors, and inspection and testing of purchased components. Procedures must be in place for verification and maintenance of purchased components, and for tracking lost or damaged components. Also, in some areas, European standards organizations are developing additional guidelines for the application of the ISO 9000 standards to specific product sectors, such as medical devices (EN 46000) and aerospace products (EN 2000 and EN 3042).

Myth No. 3

ISO 9000 registration can only be ontained by opening my manufacturing facility to an audit by a third-party entity authorized to perform this function by an EC member stat government.

This is only true if you are undertaking ISO 9000 registration as a means of fulfilling regulated product certification requirements as specified in EC legislation. In this case, final approval and registration of your quality system must come from an organization authorized by an EC member state government to perform quality systems audits pursuant to the relevant legislation - a "notified body," in EC parlance. This does not preclude having the actual audit or audits performed by a U.S. entity that operates as a subcontractor to an EC notified body. Subcontracting rules have recently been agreed to among the EC Commission and member states, under which notified bodies can subcontract ISO 9000 audit activities as long as the notified bodies retain responsibility for audit assessment. Certification of a regulated product by a notified body automatically yields EC-wide acceptance.

In nonregulated areas, any audit and registration acceptable to your customer is appropriate, whether performed by a European or non-European entity. Manufacturers interested in obtaining ISO 9000 registration should always first make sure that the registration they receive is both necessary and acceptable to the customer. A registration obtained in one EC member state may or may not currently accepted in other countries on a bilateral basis. However, there is a move in Europe to facilitate mutual recognition of quality system certificates. EC and EFTA representatives have already established a European Committee on Quality Assessment and Certification (EQS), which is intended to harmonize rules in this area and support mutual recognition of certificates. The European Organization for Testing and Certification (EOTC), created by the EC to encourage and coordinate the development of regional testing and certification arrangements in nonregulated areas, will also cover the quality area.