“The certification to this very specific, medically focused ISO standard will provide additional momentum to our effort to expand our presence in the medical assembly marketplace.”
Wauregan, CT (PRWEB) April 28, 2012
C&M Corporation, a vertically integrated manufacturer of bulk cable, coil cords, and cable assemblies has announced ISO 13485:2003 certification for C&M de Mexico, their assembly facility located in Guaymas, Empalme, Sonora, Mexico.
C&M de Mexico manufactures for a global customer base and features 18,000 feet of manufacturing space and more than 125 employees. Product offerings include coil cords and assemblies, both molded and mechanical. The facility features a LEAN manufacturing focus and cellular manufacturing concepts.
The primary objective of ISO 13485:2003 is to synchronize medical device regulatory requirements with those of quality management systems. ISO 13485 includes some requirements for medical devices and excludes some of the requirements of ISO 9001 that are not relevant as regulatory requirements.
Jesus Gamez, C&M de Mexico’s Manufacturing Manager, commented, “ISO 13485 is based on ISO 9001 but places emphasis in an organization’s ability to meet both regulatory and customer requirements, as well as effective risk management and the ability to maintain the effectiveness of their processes. ISO 13485 certification serves as a framework for compliance to the demands of regulatory agencies and the customer base.”
Kate Houghton, C&M’s Vice President of Marketing, added, “The certification to this very specific, medically focused ISO standard will provide additional momentum to our effort to expand our presence in the medical assembly marketplace.”
In addition to receiving ISO 13485:2003 certification, C&M de Mexico has also been certified to ISO 9001:2008 by QMI-SAI Global, the registrar who performed the audits.
C&M Corporation, headquartered in Wauregan, CT, is an integrated manufacturer of bulk cable, coil cords, and cable assemblies (both molded and mechanical). C&M offers manufacturing options in the US, Mexico, and China and produces a wide range of cable interconnect solutions for the Industrial, Multi-media, Renewable Energy, Military, Medical, Data Collection, and Datacom/Telecom marketplaces. C&M is a leader in providing engineered interconnect solutions through reliable customer service, world class quality systems, and a wide breadth of manufacturing capabilities that include bulk cable production, internal mold tool fabrication, and innovative assembly constructions.
Please contact C&M at 860-774-4812 for more information or visit C&M at http://www.cmcorporation.com.