Standards Update

ISO 9000 Certifications Up 151% in Nine Months

There's no letup in the corporate rush to embrace the popular ISO 9000 series of standards for quality management. So indicates the Mobil Survey, which tallies certificates around the world every nine months. In the first poll, taken January 1993, certifications numbered 27,824. In September '93, the total shot to 46,546. Last June it rose to 70,517. Britain accounted for 8,727 of the latest rise. The number was more than twice that of the nearest country, the United States. Mobil Europe Ltd. bases its survey on data its employees around the world gather. It concedes that actual totals are higher, but says the count is a good measure of growth.

Leading Testers Adopt Global Mark for EMC

A new mark of safety has begun appearing on electronic products in world trade. Called the "emc-Mark," it certifies that the product follows electromagnetic compatibility standards of Europe, Japan, and North America. The top line on the mark reads, "emc." Below that is a line reading, "EUR USA JPN." Three major organizations engaged in testing and certification joined arms to adopt the mark. They are TUV Product Service GmbH and VDE Testing and Certification Institute in Germany and Underwriters Laboratories in the United States. Each will recognize emc marks issued by the other two. Prompting the new mark: massive changes in standards for electromagnetic compatibility.

Clock Ticks in Europe for Medical Devices

Manufacturers of hundreds of thousands of medical devices sold in Europe are checking designs of their products. On January 1, a transition period began for them. Starting in 1998, the European Union (EU) will require that all medical devices-from wheelchairs to MRI machines-conform to its Medical Devices Directives. Meanwhile, manufacturers must make changes in quality systems, designs, manufacturing techniques, and testing. Also, they must pursue programs for quality assessment and certification. Manufacturers must follow the directives to prove their products are safe. According to the EU, "Medical devices should provide patients, users, and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer." The movement to promote safety of medical devices is spreading well beyond the EU. For example, the International Organization of Standardization last fall set up Technical Committee 210. Its provisional title is "General Aspects of Health Care Products." Meeting in Arlington, VA, the new group began tackling problems of risk analysis in standards for medical devices. It also intends to write guides to help device makers conform to ISO 9000 standards.

Panel Examines Gaging of Threaded Products

Have time-honored methods used to measure the threads of fasteners become threadbare? A panel of independent experts is studying the question. The Center for Research and Technology Development, part of the American Society for Mechanical Engineers (ASME), convened the group. Under scrutiny first is System 21, a simple "go/no-go" approach that has long been an ASME standard. If a bolt threads completely into a standard "go" nut but not into a standard "no-go" nut it passes inspection. Several industries, including aircraft manufacturing, nuclear power, and construction, use System 21. For more than a decade, however, critics have claimed that the procedure is outmoded. They say it fails to produce quantitative data needed to assess statistical conformance. The panel has 18 months to decide if another way would make a better standard for measuring threaded products.

ETSI Relaxes Policy on Patent Licenses

A European agency has altered its policy on patent licenses, bowing to strong objections from electronics firms in the United States. Among changes the European Telecommunications Standards Institute (ETSI) voted in: ETSI must first identify specific patented technologies needed to comply with a telecom standard. Patent owners then will have three months to decide whether to grant licenses on "fair, reasonable and non-discriminatory terms." Licensing provisions will not apply outside Europe, nor will ETSI require arbitration of disputes. Both had been requirements in the policy ETSI adopted in 1993. The agency dropped language that U.S. companies said would hobble their ability to negotiate with other firms for rights to its technology through "cross-licensing." Originally, ETSI ordered all members to sign an "undertaking" agreeing to grant licenses to other members for their inventions. Companies could refuse under the former policy, provided they did so within 180 days after announcement of a work program for a standard. U.S. firms claimed that was unreasonable.

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