CSS Pursues ISO 13485 Medical Certification for Quality Management

Officials from Connecticut Spring & Stamping (CSS), announce that the company is on schedule to be certified in 2013 to the ISO 13485 standard for quality management for design and manufacturing of medical devices.

CSS is currently certified to AS 9100, the standardized quality management system for the aerospace industry. Achieving the ISO 13485 standard demonstrates CSS’s commitment to its existing medical customers, and signals its desire to expand its growing medical customer base and further enhance its capabilities with Tier 1 suppliers. 

CSS contracted with CONNSTEP, a non-profit business consulting organization that specializes in assisting manufacturing firms implementing ISO quality management systems. A gap analysis was performed and changes are currently being implemented to prepare for the 2013 certification. 

The ISO 13485 registration audit process will include a thorough documentation review, followed by an on-site visit to review and assess CSS’s day-to-day operations. CSS will receive ISO 13485 certification upon successful completion of the audit, expected in 2013.