Articles by Steve Wichelecki

Understanding ISO 13485

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.


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Updating ISO/IEC 17025

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?

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

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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Karen Spencer, Clinkenbeard's quality manager, discusses what makes the plant stand out, advice for other plants, and looks to the future.
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2015 May

The May 2015 edition of Quality Magazine includes articles on cloud technologies, depth gages, ISO 9001, digital inspection and cool new products.

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