ISO/IEC 13485: 2003 represents the management system requirements for companies that want to maintain compliance with medical device regulations. 13485 could be implemented by companies that manufacture everything from cotton swabs to pacemakers, contraceptives to examination tables or companies that provide related services, such as sterilization, packaging or labeling.
The Dunlee division of Philips Healthcare has been manufacturing X-ray tubes since 1946. Acquired by Philips in 2001, the company’s Aurora, IL, manufacturing facility occupies 140,000 square feet, with more than 250 employees.
Like most other companies obsessed with quality, Six Sigma and other proven methodologies are essential at ITT’s Goulds Pumps Division, a pump manufacturer in business for more than 150 years. But when it comes to implementing new technologies, Robert Kilmer, product engineer with Goulds, sometimes veers off the beaten path.
The USS Exact Scan single camera system inspects the entire body side of a vehicle as it moves down an assembly line, inspecting for features such as badges, emblems, decals, door handles, running boards, wheels, lights, bumpers and body-side cladding.
In a previous column I railed against corporate cost cutting strategies where the only element taken into consideration was the money involved. The fallout from decisions made in such isolated circumstances will not be immediately evident, while the savings will be. But when the chickens come home to roost, the costs to put things right often exceed the savings many times over.
With 40% of Quality readers citing increased importance placed on quality, compared to three years ago, according to our 2009 Quality Capital Spending Survey-planning your strategy and long-term goals becomes even more important.
No matter whether you are interested in a machine tool, a metrology system or another precision device that relies on mechanical motion, what errors of mechanical motion are compensated for and how they are compensated directly impacts that system’s ability to operate at the highest level of capability.
In an effort to become more competitive, increase profitability and improve quality, and meet or exceed a customer’s schedule, companies are turning to automated processes that increase production throughput and profitability, while improving quality and work consistency.
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