Longstanding employee focus on process control is easing the way to ISO 13485 certification.
Connecticut Spring & Stamping (CSS; Farmington, CT), a family owned and managed company with over 380 employ- ees, is set on achieving certification under the ISO 13485 comprehensive management system for the design and manu- facture of medical device components. Te certification isn’t a requirement—rather, it serves as a commitment that CSS can match the stringent quality management requirements already followed by its medical device customers. CSS, which makes tight tolerance precision springs and metal stampings, prides itself on its process control, and was already certified to ISO 9001 quality management standards as well as the AS9100 aerospace quality management standards. So stepping up to the ISO 13485 medical device quality management standard did not involve massive changes. But the yearlong campaign to achieve the certification does require management support, careful planning and development of training plans and docu- mentation tools, as well as buy-in of the entire workforce.
The Path to Certification CSS had always done work for the medical device indus-
try, but began focusing on the sector in 2001, in response to the medical industry’s rapid growth. From about 8% of its work, the company aimed to grow its medical sales to about 50% of its total. To do that, CSS began developing its internal process capabilities to meet the requirements of the complex parts being manufactured and the complicated qualification processes required. Te company became adept at prepara- tion of medical part protocols to meet the needs of OEMs, who would be taking the parts into a clean room for assem- bly and sterilization. Over the past few years, this expanded medical focus
naturally progressed into the decision to pursue the ISO 13485 certification, as a way of opening up the company to pursue new business and develop new and more complex parts. “We decided to pursue the ISO 13485 medical quality certification
Michael C. Anderson Yearbook Editor
Autoloop Team Leader Dennis Palmieri inspects first-article parts at CSS. 86 Medical Manufacturing 2013