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Health Canada has issued a directive to all CMDCAS-recognized registrars clarifying appropriate issuance of ISO 13458/13488 registration under the CMDCAS program to medical device manufacturers.

According to the directive, it’s inappropriate to issue registration under the CMDCAS program in the following cases:

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The Strategic Research Institute will hold its second annual Six Sigma Strategy for Health Care forum, April 28-29 at the Millennium Knickerbocker in Chicago.

Financial pressure, limited resources, workforce shortages and increased scrutiny on medical errors have hit the health care sector hard. Many organizations have begun implementing Six Sigma to remedy these issues. The forum will feature strategies, solutions and best practices for successfully deploying the methodology into the fabric of any health care organization.

According to the institute, participants will learn practical tips for introducing Six Sigma to their organization, ideas on how to sell Six Sigma internally and case studies to verify Six Sigma’s fit in a health care environment. Delegates will witness how Six Sigma changes an organization’s culture.

The event will feature Six Sigma industry leaders from institutions such as the University of Virginia School of Medicine, International Society of Six Sigma, Charleston Area Medical Center, Blood System Laboratories, Andell Associates, St. Joseph’s Community Hospital, The Standard Register Co., Creative Healthcare USA, Mediserve Information Systems Inc., North Shore Long Island Jewish Health System and Six Sigma Brokers.

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Twenty guidance modules on specific aspects of auditing ISO 9001:2000 quality management systems are now available from the International Organization for Standardization, and another three are being developed.

The guidance modules that compose the auditing kit adopt a practical approach toward examining quality management systems. They have been developed mainly for certification body personnel carrying out quality system audits for organizations seeking ISO 9001:2000 registration as independent confirmation of their implementation of the standard.

The kit may also be useful to staff carrying out in-house audits to provide assurance to managers about their quality management system’s performance, as well as to consultants, trainers and anyone interested in quality.

The modules are being developed by the ISO 9001:2000 Auditing Practices Group established by ISO and the International Accreditation Forum, the grouping of national accreditation bodies that verify the competence of certification bodies. The documents are available by clicking here.

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Powerway Inc., a provider of product development process solutions for manufacturers, has released its new Corrective Action and Quality Planner application.

The software is part of Powerway Suite 2000, an integrated collection of solutions designed to drive continuous improvement, reduce costs and increase speed to market while conforming to international business standards and regulations.

The corrective action module offers increased traceability, enhanced reporting and the ability to address job-specific nonconformances. Powerway’s Quality Planner automates critical labor-intensive activities to improve compliance management and continuous improvement programs.

"The Corrective Action and Quality Planner enhancements will make it easier for suppliers to comply with customer-specific requirements as well as conform to the new international standard ISO/TS 16949," says Powerway CEO Ted Wozniak. "By focusing on the needs of our expanding international customer base, we have developed solutions that incorporate both usability and flexibility improvements."

Powerway launched a Spanish version of its Quality Planner application simultaneously.

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Plastics and advanced materials, micro-machining technologies and lean manufacturing will be on tap at the EASTEC 2004 Advanced Productivity Exposition.

EASTEC is scheduled for May 25-27 at the Eastern States Exposition Grounds in West Springfield, Massachusetts. It’s the East Coast’s largest manufacturing event, and this year’s exposition will mark the 25th anniversary of the program.

EASTEC includes more than 2,000 manufacturing products and services in 150,000 square feet, featuring more than 600 exhibitors. Participants will display a host of products and services including machine tools and metalworking technologies, lean manufacturing, plastics and advanced materials and micro manufacturing. In celebration of its 25th Anniversary, EASTEC will be giving away a Segway scooter and many other prizes to those in attendance.

EASTEC also features a technical conference program developed by SME, its members and industry partners. The technical conferences will feature industry experts and experienced end-users who will explain their technologies and best practices.

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Intel Corp. has awarded 16 companies its most prestigious award for suppliers, the Supplier Continuous Quality Improvement Award.

The award recognizes Intel suppliers that exhibited outstanding commitment to quality and performance excellence during 2003. The group of winning companies was honored at a ceremony in Burlingame, California, on March 23.

The SCQI winners are: Asymtek, A Nordson Co.; Disco Corp.; Fujimi Corp.; George Fischer Piping Systems Ltd.; IBM Corp.; Ibiden Co. Ltd.; Kelly Services Inc.; Kester; Nidec Corp.; Sanyo Denki Co. Ltd.; Senju Metal Industry Co. Ltd.; Shinko Electric Industries Co. Ltd.; Sumitomo Mitsubishi Silicon Corp.; TDK Corp.; Tokyo Electron Limited; and Tokyo Ohka Kogyo Co. Ltd.

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When Allen Witherspoon, general manager of GASCO Manufacturing, needed to write a quality manual to satisfy the requirements of one of his top customers, he had no idea where to start.

"I knew I couldn’t simply sit down and do it," says Witherspoon. "I didn’t have the time or the knowledge and I wasn’t sure where to begin."

Witherspoon turned to the New Mexico Manufacturing Extension Partnership. "We’re not a complex company, but I gave the MEP project manager a tour of the entire GASCO facility to see exactly how we operate," explains Witherspoon.

The MEP project manager assessed GASCO’s entire process--sales, receiving raw materials, manufacturing and warehousing--before beginning work on the manual. "As a result of the new quality control manual, the company’s processes are now formally defined and documented, and we satisfied our customer’s requirements," says Witherspoon. "We have also hired a new employee to inspect received raw material and the final product. This new hire was a direct result of the now detailed and defined inspection activities documented in our new quality control manual."

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The largest missile manufacturing facility in the world, an appliance manufacturer and 10 automotive suppliers are 2004 recipients of the 2004 Shingo Prize for Excellence in Manufacturing.

Dubbed the "Nobel Prize of Manufacturing" by Business Week, the Shingo Prize focuses on lean manufacturing practices. The prize is named after Shigeo Shingo, who helped create the Toyota Production System and other manufacturing processes. Nine state-level awards and a public-sector category, primarily for military depots doing remanufacturing, have been implemented in recent months.

Three notable achievements of the 2004 recipients include:

  • Seven of the 12 achieved product quality of less than 10 returned parts per million opportunities from the customer.
  • Seven of the 12 have inventory turns of more than 25 per year (compared to a U.S. average of 8).
  • Premium freight as a percent of production costs averaged 0.12 percent.


These data cover the full-year of 2003 and all are clear indicators of world-class manufacturing achievements.

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Agilent Technologies Inc. has signed an agreement with eBay, allowing sellers to offer pre-owned test equipment that has been assured through the new Agilent Advantage Assurance program.

The program gives customers the option to purchase on eBay Agilent test equipment that has been evaluated and fully calibrated by Agilent to meet performance specifications. The program also provides one year of free technical support from Agilent.

"This is the first time a test and measurement manufacturer has offered customers such a comprehensive program for pre-owned equipment," says Bill Highstreet, vice president and general manager of Agilent’s Financial Solutions Unit. "Customers are looking for value-priced pre-owned equipment but are concerned about unknown quality. The Agilent Advantage Assurance program instills confidence in customers who purchase pre-owned test equipment on eBay."

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Three of the world’s leading measurement laboratories, including the U.S. Commerce Department’s National Institute of Standards and Technology’ have lined up the hash marks from four of the world’s best optical frequency rulers and declared that they match.

The experiments, reported in the March 19 issue of the journal Science 1, are a significant step toward next-generation atomic clocks based on optical rather than microwave frequencies. Such clocks are expected to be as much as 100 times more accurate than today’s best timekeeping systems.

Although the new technology won’t affect average wristwatch wearers, it will provide the ultra-precise timekeeping necessary for navigation, telecommunications and basic scientific research.