Contract Manufacturing

tec5USA, Inc. has been ISO 9001:2015 certified since 1/2020. Our scope of registration is geared towards the design and manufacture of detector-array optical spectroscopy, spectrometer systems, modules operating electronics, and fiber-optic accessories.

Our QMS allows us to consistently provide products that meet customer and all applicable statutory and regulatory requirements to achieve our primary goal of customer satisfaction.

ISO 14001:2015 is the internationally recognized standard for environmental management systems (EMS).

tec5USA uses it to provide a framework for the organization to design and implement an EMS, and continually improve their environmental performance. By adhering to this standard, tec5USA can ensure they are taking proactive measures to minimize their environmental footprint, comply with relevant legal requirements, and achieve their environmental objectives.

The framework encompasses various aspects, from resource usage and waste management to monitoring environmental performance and involving stakeholders in environmental commitments.

tec5USA and their customers will benefit from ISO 27001 certification in several ways. The ISO 27001 pending certification will help reduce the risk of cyber-attacks and implements procedures and controls consistent with international best practices and standards. We conduct quarterly IT audits and third-party inspections that verify that internal controls are consistently followed.

All our employees are required to attend IT security and awareness training. This certification will also ensure ongoing compliance with several Federal and international regulations. Lastly, all customer data, including email correspondence, is maintained in a highly secured manner on tec5USA’s IT systems, which are subject to biannual penetration tests and access controls reviewed by system administrators. We maintain hourly encrypted data backup and conduct periodic tests compliant with COB standards (Continency of Business operations). In case of emergencies such as power loss or other issues at the primary office facility, tec5USA has procedures in place that allow them to operate their business and service their customers transparently from alternate locations.

ISO 13485 is designed to be used by organizations like tec5USA involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.

This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognized standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies like tec5USA get recognized as more reputable, trustworthy providers.