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European Quality Standards: A Brief Overview |
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Many of the European standards can be by Elizabeth R. Larson |
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In order to conduct business internationally, companies and organizations must have a knowledge of the vast number of standards now present on the world scene. Some are globally implemented and others nationally; ignoring them can cause trade hang-ups and cost businesses time and money. Many European standards can be confusing and intimidating to U.S. companies that must implement them. But there's no getting around them; as large corporations extend their business overseas, they will be required to comply with these norms. Those companies in search of a place in the European marketplace must be prepared to meet any necessary requirement thoroughly. This article lists the various standards and requirements currently administered in Europe and offers a brief overview of each. They include AVSQ, BS 7799, the European CE Mark directives, EAQF, EN 46000, TickIT and VDA 6.1. AVSQ ANFIA, Italy's National Association of Car-Building Industries, created AVSQ (translated as the Association of Quality System Evaluators) in 1994 to serve as the country's automotive quality requirement, a status it achieved in 1996. Italy's Fiat S.p.A.--a multinational holding company that owns all the major Italian original equipment manufacturers, including Alfa Romeo, Innocenti, Lancia, Maserati and Ferrari--uses the document as the basis for its quality process. Fiat requires all service and parts suppliers to be AVSQ-compliant, including those located in the United States. Fiat also accepts EAQF and VDA 6.1 from French and German suppliers, respectively, as well as QS-9000 from U.S. suppliers; however, it gives preference to AVSQ:1994 registration due to its additional, industry-specific requirements. AVSQ closely resembles QS-9000. It also overlaps other European automotive requirements, including EAQF and VDA, although it has specific differences. Along with EAQF, QS-9000 and VDA 6.1, AVSQ was used as a source document in creating TR (ISO) 16949, the new international automotive requirement. AVSQ relies on ISO 9001/9002 registration, with additional conformance to automotive requirements verified by an accredited registrar. Although AVSQ is consistent with QS-9000 and EAQF, the standards are not identical. In particular, AVSQ concentrates on two areas of importance to the Italian automotive industry: checking the manufacturing process's stability, and developing products from design through the completion stage. AVSQ differs from QS-9000 in five ways: customers must establish quality system qualifications for supplier processes, products and control plans; suppliers must keep customers informed of the quality levels of products provided by subcontractors; suppliers must communicate proposed changes to processes and products to its customers in advance of making those changes; suppliers must define procedures for presenting and testing prototypes and preproduction samples to its customers; control reports indicating specifications and changes in product specifications must accompany all product samples. Poland and Turkey, which do not have national automotive quality systems of their own, currently use AVSQ for supplier registration. China also is evaluating the requirements for possible future implementation. Contact: ANFIA, Via Galileo Ferraris, 64, Torino, Italy; telephone 39-0-11-561-3661; fax 39-0-11-545986 or Carwin Continuous Ltd., Publication Dept. Unit 1, Trade Link, Western Ave., West Turrock, Grays, Essex, RM20 3FJ, United Kingdom; telephone 44-170-886-1333, ext. 202; fax 44-170-886-7941
BS 7799 British industry, government and commerce stakeholders wrote BS 7799 to address information security management issues, including physical disaster, industrial espionage and fraud. BS 7799 describes about 100 individual security controls under 10 major security headings. The standard sets out information security problems and offers solutions to them. The standard consists of two parts: BS 7799: Part 1: 1995: The Code of Practice and BS 7799: Part 2: 1998: Specification for Information Security Management Systems. Part 1 provides companies with the guidance material to implement an information security management system. This part of the standard also makes best practices recommendations for supporting BS 7799's requirements. Part 2 offers organizations a basis against which to assess their own information security management systems. This part of the standard may also be used as a formal certification scheme. In April 1998, the British Department of Trade and Industry, in cooperation with the United Kingdom Accreditation Service and industry liaisons, released c:cure, BS 7799's accredited certification scheme. c:cure helps organizations safeguard their information assets and allows businesses to demonstrate their compliance with BS 7799. There is ongoing discussion about making BS 7799 an ISO standard. Contact: c:cure Scheme Manager, DISC British Standards Institution, 389 Chiswick High Road, London W4 4AL, United Kingdom; telephone 44-181-995-7799; fax 44-181-996-6411; e-mail c_cure@bsi.org.uk; Web www.c-cure.org
CE Mark The European Union created the CE Mark to regulate the goods sold within its borders. The mark represents a manufacturer's declaration that products comply with the EU's New Approach Directives. These directives apply to any country that sells products within the EU. Though not a quality standard, the CE Mark indicates that the product bearing the mark has met the EU's minimum legal requirements for health and safety. The mark must be affixed either to the product or product packaging, and must also be present on all corresponding product literature. Currently, 24 New Approach Direc-tives exist, covering 14 product lines including everything from toys to hot water boilers to recreational crafts. The directives' implementation dates range from 1993 to 2007. Of all the directives, the two getting the most attention are also two of the newest: the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Device Directive (98/79/EEC).
The IVDD divides in vitro diagnostic devices into four classes based on factors including potential risk and intended use. These categories include: devices for self-testing, used primarily in a home environment by laypersons; blood grouping systems, reagents and reagent products; materials for determining toxoplasmosis, rubella or irregular antibody conditions; and devices not listed in Annex II or intended for self testing. IVDD certification will be possible by June 7, 2000, and will become mandatory by December 2003. Contact: Global Engineering Documents, 15 Inverness Way E., Englewood, CO 80112; telephone: (800) 854-7179; fax: (303) 397-2740; Web: global.ihs.com
EAQF Published in 1994, EAQF is an ISO 9001-based French automotive requirement that, when translated into English, stands for evaluation, aptitude, quality and supplier. EAQF is used by Citroën, Fiat, Peugeot S.A. and Renault, and administered by the Groupe d'Etude Sur la Certification Automobile (GECA). GECA's "Practical Automobile Rules" clarifies the wording of certain parts of EAQF:1994, harmonizes the judgments of auditors and certifying bodies, specifies the rules for assessing automotive quality systems according to EAQF and provides information regarding grading against the requirements. Manufacturers already certified to ISO 9000 must go through a separate procedure in order to receive EAQF:1994 approval. French automobile manufacturers recognize EAQF assessments when they are conducted by approved certifying bodies, including AFAQ, UTAC and AENOR. These certifications may also be recognized under two mutual-recognition agreements for supplier system audits formed between French automakers, and their German and Italian counterparts. Because of their similarity, EAQF:1994, VDA 6.1 and AVSQ:1994 give similar results to their users. Each has a different grading method, however, and the differences in the way the separate requirements are organized prevent direct conversion from one to another. Contact: GECA, Web: www.eaqf-geca.org
EN 46000 EN 46000, the Medical Device Quality Management Systems Standard, addresses the particular concerns of the medical devices industry in interpreting and implementing ISO 9000. Published in 1994, the standard provides medical device manufacturers, distributors, importers, assemblers, component manufacturers and service organizations with an industry-specific quality management system. EN 46000 must be used in combination with ISO 9001. EN 46000 embraces the principles of good manufacturing practice, commonly used in medical device manufacture. It offers its users an auditing process similar to a quality management systems audit. The standard also helps users market their products throughout the EU because its conformity assessment process under the Medical Device Directive 93/42/EEC permits CE marking. Conversely, if a company wants to be CE compliant, it must also comply with EN 46000. EN 46000 is technically equivalent to ISO 13485:1996, an international medical device standard. So few differences exist between the two that if an organization is prepared to comply with one, it may easily comply with the other as well. Contact: BSI Standards Dept., UK Desk, 389 Chiswick High Road, London, W4 4AL, United Kingdom; telephone 44-181-996-9001; fax 44-181-996-7001; e-mail info@bsi.org.uk; Web www.bsi.org.uk
TickIT The British Department of Trade and Industry launched the TickIT initiative in the late 1980s to formulate a scheme for applying ISO 9000 to the software industry. Rather than a manufacturing standard extended to software, TickIT offers the software industry its own specific scheme. TickIT does not impose rules on software developers; instead, it places new accreditation requirements on certification bodies. The scheme's guidelines relate to requirements outlined in ISO 9001:1994; ISO 9002:1992; ISO 9003, "Guidelines for the application of ISO 9001 to the development, supply and maintenance of software"; and ISO/IEC 12207 "Information technology--software lifecycle processes." One of TickIT's central purposes involves encouraging software system developers to consider how to achieve quality in the context of their industry. TickIT strives to improve the professional practices of the software sectors' quality management systems auditors and improve market confidence in third-party quality management systems certification through industry-specific certification bodies. It publishes The TickIT Guide as guidance material for all stakeholders. As of Aug. 1, 1998, the United Kingdom Accreditation Service changed TickIT from mandatory to voluntary for bodies providing certification relating to software. TickIT now will be addressed under UKAS's normal procedures for ensuring that competence matches clients' software activities. All British government departments and major purchasers recognize TickIT, which is compatible with European requirements for accredited quality system certification. Contact: The DISC TickIT Project Office, 389 Chiswick High Road, London W4 4AL, telephone: 44-181-966-7427, fax: 44-181-996-7429, e-mail: tickit@bsi.org.uk
VDA 6.1 VDA 6.1 is the German automotive industry's quality requirement. Published by the Association of the German Automobile Industry (Verband der Automobilindustrie), VDA 6.1's fourth edition was released in 1998, becoming valid Jan. 1, 1999. The document was written by a group of 27 major stakeholders, including DaimlerChrysler, Audi, BMW and Volkswagen, which created VDA 6.1 to exceed ISO 9001:1994's requirements and integrate other supplier quality standards (including EAQF, AVSQ and QS-9000:1995) into a cohesive quality system specific to the German automobile industry. As of Sept. 30, 1997, Volkswagen, BMW and DaimlerChrysler required their European original equipment manufacturer suppliers to be VDA 6.1-certified. VDA 6.1 consists of two essential parts: management responsibilities and business strategy, and product and process requirements. These two main parts encompass 23 elements. The management section discusses issues such as internal quality audits, training and personnel, product safety and corporate strategy. Product and process describe the requirements for items including design control, process planning, purchasing, process control, corrective and preventive action, control of quality records and statistical techniques. Contact: Verband der Automobilindustrie e.V., Quality Management Center, Lindenstrasse 5, Frankfurt 60325 Germany; telephone 49-69-97-507-332; fax 49-69-97-507-331; e-mail: bestellung@vda-qmc.de; Web: www.vda-qmc.de About the author Elizabeth R. Larson is Quality Digest's news editor. |
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The Medical Device Directive. The MDD, which went into effect last summer, has 23 articles, 12 annexes and 18 classification rules intended to harmonize the standards--including design, testing and marketing--for all medical devices sold within the EU. The MDD works in tandem with ISO 9000 and EN 46000 with regard to certain medical devices.