SMTEK International, Inc. awarded ISO 13485 certification
Jun 18, 2004
Moorpark facility achieves medical device quality standard, other facilities slated
SMTEK International, Inc. (Nasdaq:SMTI) announced its Moorpark production facility achieved ISO 13485 certification as a high-quality medical devices developer and manufacturer with technical and administrative controls to assure safety and reliability under all regulatory and customer requirements. It is anticipated that SMTEK's other facilities, including its Asian facility, will complete the same certification by calendar year end.
ISO 13485 is the standard specific to medical devices and requires higher levels of quality in all areas of development, production and servicing, and also requires more stringent detail and record-retention of technical data, complaints and follow-up, environment monitoring, risk identification and analysis, and accountability/traceability. Although SMTEK is already compliant with the FDA's revised Quality System Regulation which is based on ISO 9001 and ISO 13485 quality system standards, SMTEK is pursuing ISO 13485 certification for all of its production facilities to ensure the superiority of its quality and business management systems. ISO 13485 is globally recognized as the most stringent standard of quality control for medical devices.
SMTEK President and Chief Executive Officer Edward Smith commented: "We are committed to delivering the highest quality capabilities possible to our customers. Although we believe that we have been performing to this kind of quality standard for some time, it is gratifying to receive third party independent validation of it. Additionally, this accomplishment is another step in the implementation of the Company's strategic plan to further penetrate the medical market that already plays an important role in our current business.
"We consider this certification an important distinguishing factor and a competitive advantage for the Company," Smith added. "Early compliance with this certification provides SMTEK a new opportunity to increase market share."