Able Electropolishing has been ISO 13485:2003 certified for medical equipment components and renewed its ISO 9001:2008 certification for quality management systems.
Based in Chicago, Ill., Able provides metal electropolishing, passivation, and titanium anodizing services. The company sought the new ISO certification to better serve medical and other high-precision industries.
As set forth by the International Office for Standards, certification in ISO 13485:2003 acknowledges that Able has demonstrated its ability to produce medical equipment parts that meet both consumer and regulatory requirements. Moreover, the certification details Able’s ability to provide medical equipment manufacturers with metal parts of ISO-standard safety and quality.
“Able has participated in the medical device market for many years,” said Scott Potter, Able Electropolishing sales manager. “Our current customers include nationwide OEMs [original equipment manufacturers] and contract manufacturers for medical devices.”
The certification was granted following a thorough review of Able’s equipment, facilities, staff and other factors indicative of the company’s quality control and production capabilities. The certification is valid for two years.
Able’s Chicago plant offers electropolishing of nearly any metal including stainless steel, aluminum, copper, nickel, titanium and nitinol.
Photo of electropolished Nitinol components courtesy of Able Electropolishing.
Able Electropolishing Adds ISO for Medical Equipment
Published October 10, 2012
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