AccuSpec Electronics, LLC Awarded ISO 13485 Certification for Manufacture of Medical Devices
November 27, 2007 – Erie, PA
AccuSpec Electronics, LLC, an Electronics Manufacturing Service provider in McKean/Erie, PA, recently received ISO 13485:2003 certification for its medical electronics-related manufacturing operations. The certification provides AccuSpec's customers the assurance of stringent control of business practices, and manufacturing processes used to produce medical electronics devices as their electronic manufacturing service provider.
Adherence to international standards is of utmost importance for manufacturers who’s core belief is based on being the best in quality. AccuSpec has maintained ISO 9000 certification continuously since 2003 and is currently certified to ISO 9001:2000. ISO 13485 supplements the ISO 9001 standard with an emphasis on systems that are specific to the medical device industry. Some of the additional requirements of ISO13485 relate to design controls, record retention, regulatory actions, process controls, special processes and traceability, which are considered more critical for the medical device industry. AccuSpec’s future goals include obtaining full FDA and military certifications.