SEACOMP’s production facility in Tijuana, Mexico, achieved ISO 13485 certification in August 2024, a major milestone that underscores its commitment to excellence in manufacturing standards, particularly in the field of medical device production. This certification establishes SEACOMP Mexico as a leading partner for medical device companies seeking reliable, compliant manufacturing solutions.
ISO 13485 is the medical device industry's most widely recognized quality management standard. It sets a rigorous framework governing factory activities to ensure consistent, high-quality products. Achieving certification involves a two-phase process. First, the manufacturer must establish and implement a comprehensive quality management system (QMS). This includes internal audits and corrective actions to meet ISO 13485's requirements. The second phase is an external audit conducted by a third-party regulatory agency, which thoroughly assesses the facility's documentation, process control, and overall adherence to these standards.
Attaining ISO 13485 certification is significant for SEACOMP and our customers. This achievement reflects our ability to deliver quality and manage risks effectively. By following the ISO 13485 standard, we ensure that all production processes are meticulously controlled and that every team member at the factory is aligned with quality goals and responsibilities. For our customers, this certification gives confidence in our ability to produce reliable, high-quality Class Ⅰ and Class Ⅱ medical devices.
With ISO 13485 certification, SEACOMP Mexico is well-positioned to support the medical device industry, providing customers with the assurance of a quality-driven electronics manufacturing partner.