GPI Prototype & Manufacturing Services located in Lake Bluff, IL is currently certified by Eagle Registrations Inc for ISO 9001:2015, ISO 13485:2016, and AS9100D. We are also ITAR and FDA registered.
ISO 9001 is a globally accepted set of requirements, procedures and processes used to manage a business and provide quality products and services. The quality management system provided with ISO 9001 allows companies to identify, measure, improve and control core business processes. Requirements include internal audits, record keeping, process procedures & monitoring, management reviews, corrective action plans and continuous improvement.
ISO 13485 certification is an internationally recognized standard that helps medical device manufacturers and suppliers improve their FDA and regulatory compliance. It focuses on what the manufacturer does to deliver safe and effective medical devices. The standard is based off of ISO 9001, with an emphasis on maintaining system effectiveness and monitoring customer feedback.
AS9100C provides businesses in the aircraft and aerospace industries with standardized processes used to create quality products and meet regulatory requirements. AS9100C expands the requirements of ISO 9001 to include configuration management, reliability, maintainability, safety and special processes. AS9100C requires that all elements of the production and supply chain produce quality products that are safe and reliable.
GPI Prototype and Manufacturing Services is FDA registered. This registration is an important milestone in moving the company forward to supplying serial production to our OEM medical device customer base.
GPI is also an ITAR registered company with the United States Department of State. ITAR regulates the export and import of U.S. military and defense related equipment and information. Companies receiving this certification have corporate procedures and controls in place to ensure compliance. The ITAR Registration allows GPI to support military and defense-related projects in the United States.
We are also a 3d printing service provider for GSA under contract #GS-03F-098CA. GSA provides private sector professional services, equipment, supplies, and IT to government organizations and the military. Services are available through multiple award schedule 36, special item number (SIN) 51 400. SIN 51 400 was established in 2015 to be the premier acquisition resource for additive manufacturing technologies within government.