GMI has received its ISO 13485 (Medical Devices – Quality Management Systems — Requirements for Regulatory Purposes) Certificate from UL/DQS. The date of the original certification is 11/04/14. This makes GMI a holder of three quality certifications: ISO 9001, ISO 14001, and now ISO 13485.
Medical devices come in close contact with patients and range from minor support for medical conditions to providing lifesaving capability. As such, they demand high criteria. OEMs that establish and implement an ISO 13485 Quality Management System are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Likewise, these OEMs turn to EMS organizations like GMI who share in this world class approach to manufacture products to the ISO 13485 Standard.
ISO 13485 is typically required for medical products. For GMI, it is a natural progression in that this newer standard is very much harmonized with the ISO 9001 Standard. In analyzing the principal differences between the two standards, a couple stand out. ISO 9001 requires GMI to demonstrate continual improvement of its operations, whereas ISO 13485 requires GMI to maintain its operations. The other variance is ISO 9001 has requirements regarding Customer Satisfaction. This requirement is absent from ISO 13485.
During its initial launch into Costa Rica, GMI met a cluster of multinational medical firms operating in the various free trade zones located in and around the San Jose Valley. Soon, GMI discovered these firms had a great deal of product design, development, and assembly activity in Costa Rica. Fortunately, many of these companies had electronic requirements; before GMI arrived, the only option for these companies was importing from abroad. GMI is currently working with several of these firms; in order to thoroughly engage with each, ISO 13485 certification was a requirement. With GMI’s support, these companies now have the opportunity to shrink manufacturing lead-times, decrease logistics costs, and increase inventory turns.
While GMI’s Quality Management System provides the game plan for how it delivers quality manufacturing services to its valued customers, it is the dedication, capability and experience of its time-tested associates that create the Winning Team.