CFS ACHIEVES ISO 13485:2003 and ISO 9001:2000 CERTIFICATION

CHANHASSEN, MN (November 30, 2007) - Custom Fab Solutions, LLC (CFS), a contract manufacturer and custom plastic/metal fabricator serving technology industries has achieved ISO 9001:2000 and ISO 13485:2003 certification from BSI Management Systems, a leading and globally recognized quality management systems certification body.

The ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard and ISO 9001:2000 is an internationally recognized QMS standard, both developed by the International Organization for Standardization (ISO). To be certified to the 13485:2003 standard, companies must implement a Medical Device QMS ensuring steps have been taken to identify, manage and minimize risks involved with the manufacturing and sales of medical devices. The 9001:2000 standard complements the 13485:2003 standard and requires a well documented QMS that ensures consistency and improvement of working practices, including the products and services produced. 

“By earning ISO 9001:2000 and ISO 13485:2003 certification, CFS is further demonstrating its commitment to quality management,” said Gary Pearsons, President of BSI Management Systems. “By formalizing their management system and using ISO 9001:2000 and ISO 13485:2003 as an extra set of eyes, CFS will be able to monitor quality and continually assure customers that they are doing everything they can. The company’s employees are committed and use well organized processes – ISO 9001:2000 and ISO 13485:2003 certification can only serve to improve an already top-of-the-line business.” 

CFS began its registration process in December 2006.  As part of the ISO 13485:2003 and ISO 9001:2000 process, BSI performed on-site assessment, examined CFS’ documented procedures and audited its overall operations. To determine continued compliance with ISO 13485:2003 and ISO 9001:2000, BSI will periodically conduct routine surveillance audits of CFS’ business operations. 

Conformance to the ISO 13485:2003 and ISO 9001:2000 Quality Management System standards required the implementation of procedural changes, training, increased documentation, and adjustments to operating systems on every level of the manufacturing process at CFS. "Our success in achieving this goal is due to the tremendous dedication and teamwork of everyone in the company," said Larry Vortherms, Vice President and General Manager of CFS, "ISO registration supports our pursuit of continuous improvement and an on-going commitment to provide our customers assurance of product quality."  “The ISO 13485:2003 and ISO 9001:2000 certifications of CFS are expected to have a substantial positive impact on our future as a Quality and Customer oriented manufacturer” said Mike Elftmann, President of CFS.

About BSI Management Systems. BSI is the world’s leading management registrar. Founded in 1901, BSI has certified more than 60,000 locations in nearly 90 countries. Many ‘Global 500’ companies have chosen BSI as their preferred ISO 9001:2000, ISO/TS 16949:2002, ISO 14001:2004, ISO 13485:2003 or ISO/IEC 27001:2005 registrar. BSI’s registration experience covers virtually every industrial and commercial sector (i.e., automotive, aerospace, chemical and allied processes, IT/software, medical devices, and service). 

About Custom Fab Solutions. CFS is a Minneapolis-based contract manufacturer serving technology markets. The company is vertically integrated and specializes in Teflon®, PFA and thermoplastic fabrication. The company has expertise in metal fabrication, electro-polishing and other surface treatment services. The company combines its capabilities with customer needs to integrate instrumentation and controls into a ready-to-use product. CFS primarily serves the photovoltaic, medical, pharmaceutical, semiconductor, disk drive, aerospace, food and electronics industries, where precision and contaminant-free material/products are required. The company web site is located at: www.CustomFabSolutions.com.


Contact: Amber Mohlman
Phone: 952.227.6600
e-mail: TechnicalServices@CustomFabSolutions.com