SGO Medical Achieves ISO 13485:2016 Recertification
Zero Non-Conformities in Comprehensive Audit
SGO Medical is proud to announce the successful completion of our ISO 13485:2016 surveillance audit conducted by TÜV SÜD, one of the world's leading certification bodies. The comprehensive three-day audit covered all aspects of our quality management system and concluded with zero major or minor non-conformities — a testament to our team's dedication to quality excellence.
Audit Scope
The audit team from TÜV SÜD evaluated the following areas of our operations:
- Management responsibility and resource management
- Product realization processes including design and development
- Purchasing controls and supplier qualification
- Production and service provision
- Monitoring, measurement, analysis, and improvement
- Risk management processes per ISO 14971
- Post-market surveillance and complaint handling
Continuous Improvement Initiatives
As part of our ongoing commitment to quality improvement, we have implemented several enhancements to our QMS over the past year, including digitization of our document control system, implementation of real-time SPC monitoring on all critical manufacturing processes, and enhanced supplier audit program with risk-based scheduling.
Our Quality Director, Ms. Li Wei, commented: "This result reflects the hard work and dedication of our entire team. Quality is not just a department — it's embedded in our culture and every process we execute."
