Sparton Corporation Receives Certification for Medical Device Standards EN 46001 and ISO 13485
(JACKSON, MICHIGAN)-October 8, 2002-Electronics Design and Manufacturing Services (EMS) provider Sparton Corporation (NYSE:SPA) announced it has received certification for European Standard EN 46001 and ISO 13485.
In July of this year, Sparton Corporation’s DeLeon Springs, Florida facility passed the medical device quality audit. Official certification for EN 46001 and ISO 13485 followed the completion of the audit.
Both certifications are based upon Sparton Corporation’s procedures and processes, as applicable to medical product engineering and manufacturing. The Norwegian Notified Body, DET NORSKE VERITAS (DNV), performed the quality audit to ensure Sparton procedures met the medical directives described by ISO 13485 standard.
“Sparton’s successful completion of this audit will provide an additional level of service for our customers by demonstrating that Sparton’s internal systems meet industry recognized standards. In addition, Sparton’s engineering and manufacturing documentation systems will be in alignment with our customers’ systems, since all are based on a common medical standard." stated Robert Kundinger, Director of Medical Business Development.