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ISO 13485:2003 and Medical Devices Harmonize
Quality Digest
The European Commission has recognized EN ISO 13485:2003 as a harmonized standard for medical device manufacturing quality management systems for regulatory purposes under the three medical device directives, the Medical Device Directive, Active Implantable Medical Device Directive and In…
New X-Ray Systems Feature Beryllium-Free Targets
Quality Digest
In an effort to increase the safety of its products, phoenix|x-ray Systems + Services Inc. has created beryllium-free targets in all of its X-ray systems with open tubes. The new targets eliminate the potential harmful residual effects that can come from X-ray exposure to beryllium…
Lean Learning Center Offers Laboratory Program
Quality Digest
The Lean Learning Center has released its Lean Learning Laboratory methodology and training program. The program is designed to provide a framework for companies to learn, experiment and apply the rules, principles and tools of lean within a shop-floor environment. "The L3 concept is…
Six Sigma Qualtec Launches Telecom Practice
Quality Digest
Six Sigma Qualtec, a provider of performance improvement training, consulting and technology, has launched a telecommunications practice. SSQ’s practice is designed to help traditional telecommunications providers such as Regional Bell Operating Companies, wireless phone firms and…
PowerSteering to Drive Six Sigma and Lean for Tyco
Quality Digest
Tyco International Ltd. has selected PowerSteering Software’s enterprise program management solution to support Six Sigma and lean initiatives in all five of its business units. At full deployment, employees across the company will use PowerSteering to manage thousands of Six Sigma…
Automotive Industry Applauds New Lean Quality Methodology
Quality Digest
Lean Quality, a methodology developed by Attensity, is gaining acceptance among automotive industry analysts, research institutions and quality experts. The Lean Quality methodology promises to deliver increased insight into the quality chain, driving quality improvement, reducing warranty…
Instantis’ Executive Advisory Board Welcomes Renowned Six Sigma Experts
Quality Digest
Instantis, a provider of software solutions for managing enterprise performance initiatives has established a Six Sigma executive advisory board. Instantis created the board with hopes of bringing together key practitioners to define the company’s future direction and advise Instantis in…
White Paper Describes Methodologies to Optimize Working Capital
Quality Digest
Aceva Technologies Inc., a developer of working capital management solutions for global enterprises, has increased use of Six Sigma methods by its enterprise clients seeking to improve financial process work flow to optimize working capital management. To document its work, the company…
Leap Technologies Establishes New Training Programs
Quality Digest
Leap Technologies has released three new training programs for improving Six Sigma results. The latest additions to Leap’s repertoire come on the heels of more than three years of research and testing with Six Sigma organizations, including Cott Beverages, IMC Global, Standard Register…
Will The Real Six Sigma Experts Please Stand Up?
Greg Brue
From its inception, Six Sigma was considered revolutionary. The six original pioneers who implemented the methodology at Allied Signal--the only true Senior Master Black Belts--vowed that the system would unearth inefficiencies in business operations that lead to outrageous levels of…
Six Sigma in Health Care
Dave Wojczynski
The following article, the first of a two-part series, outlines the growing need for Six Sigma initiatives in the outpatient health care market. In part one, we’ll compare a series of health care-specific businesses with parallel enterprises from other industries in order to categorize…
Lean Manufacturing Certification Launched by Consulting Firm
Quality Digest
Lean manufacturing certification, which helps manufacturers achieve the benefits of lean principles, has been launched by R. Michael Donovan and Co. The certification program illustrates lean manufacturing principles and an action plan to achieve certification. It provides a numerical score…
Six Sigma for Financial Services Forum to Convene
Quality Digest
Following a wave of financial institutions implementing Six Sigma, WCBF will convene its Successfully Implementing Six Sigma in Financial Services summit on June 23 and 24 in New York. The forum, which will feature leaders in Six Sigma deployment and finance, also features preconference…
Tennessee to Host International Dimensional Workshop
Quality Digest
The sixth annual International Dimensional Workshop will be held May 10-14 at the Nashville Marriott Hotel in Nashville, Tennessee. The workshop will open on May 10 with the National Requirements Day for Dimensional Metrology, co-hosted by the Oak Ridge Metrology Center and NCSL…
Beta LaserMike Snares ISO 17025 Accreditation
Quality Digest
Beta LaserMike, a global manufacturer of precision measurement and control systems, has received accreditation under ISO 17025. ISO 17025 is an international standard that assesses the technical competency of calibration laboratories and ensures properly trained personnel, and controlled…
Webinar to Provide Overview of Risk Management Guideline
Quality Digest
In response to increased demand for information about ISO 14971:2000 and the concept of risk management for medical device manufacturing, BSI Management Systems has launched its Overview of ISO 14971 Webinar. The Webinar will cover the basic principles and concepts of risk management as…
Applicants Sought for John M. Eisenberg Patient Safety and Quality Awards
Quality Digest
The Joint Commission on Accreditation of Healthcare Organizations and the National Quality Forum are accepting applications for the John M. Eisenberg Patient Safety and Quality Awards. The Eisenberg awards recognize individuals and health care organizations that make significant…
ISO/TS 16949 and the IAOB-IATF Infrastructure
Under QS-9000, suppliers relied on the Supplier Quality Requirements Task Force for guidance and direction in dealing with questions related to the standard’s requirements. With the global application of ISO/TS 16949:2002, a globalized group was needed to offer the same direction that was given…
Health Canada Issues CMDCAS Directive
Quality Digest
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…
Automotive Executives and Suppliers to Meet at AutoMan Global 2004
Quality Digest
Executives from automakers and automotive suppliers will meet on June 8 and 9 at the Ritz-Carlton Hotel in Dearborn, Michigan, in the first global automotive manufacturing conference, AutoMan Global 2004. Organized by Automotive Manufacturing Solutions magazine, the AutoMan Global…
Companies Ally to Offer GMP Compliance Seminars
Quality Digest
Blue Mountain Quality Resources Inc. has partnered with eCalibration Inc. to offer three training seminars for GMP compliance. The training sessions will provide an opportunity for attendees to meet colleagues dealing with the same issues in a variety of situations and surroundings. They’re…
Lack of Advancement Opportunities Chief Reason for Employee Turnover
Quality Digest
According to a recent survey, 39 percent of executives say that good employees are most likely to quit their jobs due to a lack of advancement opportunities. The survey, developed by Robert Half International Inc., shows that unhappiness with management is the second most common…
APICS Conference to Explore Supply Chain Networks
Quality Digest
The 2004 APICS International Conference and Exposition, slated for Oct. 10-13 in San Diego, will feature a three-session interactive educational event focused on supply chain network competition. The sessions will focus on five principles that govern the success of a company’s supply…
ISO Offers Free ISO 9001:2000 Auditing Kit
Quality Digest
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…
Forum to Reveal Trends in Six Sigma for Health Care
Quality Digest
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…

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