Articles by Steve Wichelecki

Understanding ISO 13485

January 2, 2008
ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes.
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Tech Showcase: X-Ray Inspection Today

October 3, 2007
The use of X-ray-based nondestructive test methods dates back more than a hundred years, with the advent of film-based radiography. This article describes a number of X-ray-based offerings for today’s nondestructive testing applications.
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Updating ISO/IEC 17025

September 28, 2007
This summer marked the deadline for implementation of ISO/IEC 17025: 2005 General Requirements for the Competence of Calibration and Testing Laboratories. This came after a two-year transitional period in which accreditation bodies recognized by the International Laboratory Accreditation Cooperation (ILAC) had been assessing laboratories to the requirements of the superseding standard, which replaces ISO 17025: 1999.
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Tech Showcase: Which Hardness Test Works?

July 31, 2007
Used to check material uniformity or processing treatment, most hardness tests employed in quality control applications yield numerical values based on a material’s resistance to indentation under the conditions imposed by the particular test. Resistance to scratching and the measurement of the amount of energy absorbed by a material when struck by a falling object also are measures of hardness.
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Tech Showcase: The Right Borescope

June 1, 2007
Industrial borescopes generally fall into two categories: rigid borescopes and flexibleborescopes, also known as fiberscopes. The type of borescope employed is contingenton the application. These devices are used in a number of industries to attainquality assurance, enabling inspection for manufacturing defects withoutnecessitating part destruction. They also are used in equipment maintenance programs,eliminating the need for teardowns when checking for defects.
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 In honor of World Quality Month, we spoke to James Rooney, ASQ Past Chairman of the Board of Directors 2013, for his take on quality around the world.
For more information, read the ASQ Speaking of Quality column.
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