Reading time ( words)
Sypris Electronics LLC, a subsidiary of Sypris Solutions Inc., has achieved ISO 13485 re-certification from NSF-ISR, a division of the global public health organization NSF International.
ISO 13485 is the established quality standard for manufacturers of medical devices and has been established by the International Organization for Standardization (ISO), which is the largest developer and publisher of international standards for the implementation of Quality Management Systems.
The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.
“By achieving ISO 13485 registration, Sypris Electronics is once again demonstrating its commitment to quality and safety,” said Andy Weinbach, Global Managing Director, NSF-ISR.
“The ISO 13485 registration allows us to leverage our operations and engineering capabilities to further expand our presence in the medical device industry,” commented Jim Long, Vice President & General Manager of Sypris Electronics. “This re-certification serves as the cornerstone for our ongoing commitment to service the medical device industry.”
About Sypris Electronics
Sypris Electronics is a trusted provider of electronic solutions, addressing customers’ needs for building complex, mission-critical electronic and electro-mechanical devices and integrated systems. Backed by 50 years of experience, Sypris’ engineering and manufacturing services span our customers’ product life cycle all within a culture of continuous improvement and Six Sigma/Lean thinking. Partners from multiple agencies and tier one companies in Military (DoD), Space, Medical, Civil Avionics, Telecom, and Industrial markets team with Sypris to deliver high-reliability electronics built with strict adherence to regulated requirements. For more information, please visit www.sypriselectronics.com.
About NSF International Strategic Registrations (NSF-ISR)
NSF International Strategic Registrations (NSF-ISR) offers comprehensive management systems registrations to internationally accepted standards for quality assurance and environmental protection for the medical device, automotive, aerospace, chemical, energy and manufacturing industries (e.g. ISO 9001, ISO 14001, AS9100, TS16949, etc.). NSF International (nsf.org) is a global independent organization that writes standards, and tests and certifies products for the water, food, health sciences and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide.