MENTOR, OH ― January 2018 ― Libra Industries, a privately held electronics manufacturing services (EMS) provider, s pleased to announce that its Mentor facility has passed the recertification audits for its ISO 9001:2008 and ISO 13485:2012 certifications. With the recertification, Libra Industries – Mentor is equipped to serve the aviation, space and defense as well as medical device industries with a proven quality management system.
“Libra is tremendously honored to renew our ISO certifications,” David Henison, Libra Industries’ CFO. “The renewal validates the confidence we have in the quality of our medical devices and it reflects the long-term focus we have had in supporting the medical segment.”
All four of Libra Industries’ state-of-the-art manufacturing facilities in Northeast Ohio and Texas, are certified to ISO 9001:2008 and ISO 13485:2012. The company also is certified to FDA, UL, CSA, NIST and ITAR standards. Libra Industries serves a diverse base of industries such as medical, military/aerospace, industrial and LED lighting, and these certifications ensure that the company can meet the highest quality requirements.
The ISO 9001:2008 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. Libra Industries demonstrated its continued effort to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. ISO 13485:2012 was published in January 2012 and supersedes ISO 13485:2003. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. It provides assurance to medical device end-users outside of the United States and assurance of compliance to the European legislation.