C&J Industries Receives Coveted Medical Certification

Thursday, January 7, 2010

C&J Industries announced today that the company has achieved ISO 13485 certification from Underwriters Laboratories. The scope of the certification includes Contract Assembly, Subassembly of Mechanical Medical Devices and Molded Components for Medical Devices. In addition, C&J has also received verification that its Quality Management System is certified to the updated ISO 9001: 2008 standard.

"These certifications are part of an ongoing strategic business plan to meet or exceed the requirements of our Medical and Pharmaceutical customers," stated Dennis Frampton, President of C&J Industries. "The ISO 13485 registration is very significant as we expand our Contract Medical Device services," he added.

Many companies are familiar with the ISO 9001 quality standard. ISO 13485 is a much more comprehensive quality system with significantly more stringent requirements. For example, there are roughly 1 million companies worldwide that are registered to the ISO 9001 quality standard. There are less than 2,600 companies in the United States that have achieved ISO 13485 certification.

"The ISO 13485 quality management system will result in more proactive involvement with our customers from every department at C&J Industries," stated Dave Lennox, VP of Operations. "Risk assessment and problem avoidance will take on even greater importance than they already do," he added.

Risk assessment has been moved to the beginning of any product fulfillment project: Sales & Estimating. "As a result of ISO 13485, C&J has revamped our Quotation and Project release systems," stated Mark Fuhrman, Director of Sales & Marketing. He added, "Our Engineering and Estimating departments have created entirely paperless systems that have reduced internal lead-times by nearly a week."

"The ISO 13485 Quality Management System encompasses every aspect of our business," said Eric Sharman, Director of Engineering. He further added, "It impacts everything from product review to assembly procedures and sterilization validation. There's not a department or process that hasn't been affected"

C&J Industries is a full-service Medical Contract Manufacturer specializing in Plastic Product Design & Development, Contract Medical Device Assembly and Medical Injection Molded Components.

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