Swiss Excellence: Where Quality and Reliability Converge

Our manufacturing process is meticulously planned and executed, starting with a thorough design for manufacturability (DFM) analysis. Insights from prototype production and customer feedback are integrated before freezing the process, ensuring no changes are made without prior customer approval. This guarantees that serial production is identical to prototypes, eliminating the need for requalification of PCBs when transitioning to mass production.

With unique production lot numbers, our ERP and document management system ensure complete traceability. You can quickly access detailed information about materials, equipment used, personnel involved at each process step, their qualifications, microsections, and test results. This allows for immediate identification of any potentially affected production lots and products if an issue arises.

Understanding the critical role of documentation, we customize reports such as first article inspection reports (FAIR), acceptance inspection reports (AIR), certificates of conformance (COC), and change requests to your specifications. We preserve microsections and test coupons for a minimum of 10 years and securely archive travelers in our digital document management system.

Quality assurance is paramount, with extensive testing procedures that include 100% automated optical inspection (AOI), electrical testing, and microsections after each metallization step and the final product. Our state-of-the-art equipment features IST-Tests, ion contamination tests, HAST-tests, high-definition optical microscopes, electronic microscopes, ion cross-section polishers, X-ray, and 3D measurement tools. For implants and upon request, we verify functionality pre- and post-testing.

We adhere to strict qualification standards to ensure equipment, systems, and processes are correctly installed, operate as intended, and perform reliably. This includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) procedures. Any process changes or new equipment implementations are subject to prior customer approval to maintain product consistency.

Our workforce undergoes rigorous training and qualification, with three levels of certification for production and quality assurance roles. Employees are only permitted to perform tasks corresponding to their qualification level, and requalification is mandatory to maintain their status. Lapsed qualifications result in employees being restricted from specific tasks until requalification is achieved.

GS upholds the highest standards of compliance and quality. We are ISO 9001 and UL certified and adhere to ROHS, REACH, and conflict mineral regulations. For implant products, we follow an internal standard to ensure compliance with current good manufacturing practices and customer requirements. Our certification process for ISO 13485 is currently in progress.