SE-TEC has been awarded ISO 13485 certification and has confirmed its ISO 9001 certification
SE-TEC has successfully completed its initial certification to DIN EN ISO 13485:2021-12 (ISO 13485:2016) for medical technology and, at the same time, confirmed its recertification to DIN EN ISO 9001:2015.
With this step, SE-TEC is taking its quality management to a new level and strengthening process reliability throughout its electronics manufacturing operations.
ISO 13485: The highest standards for quality and processes
ISO 13485 sets particularly high standards for:
- Documentation and traceability
- Traceability of materials and processes
- Risk management throughout the entire product lifecycle
- Process control and validation
These enhanced standards will apply to all electronic assemblies at SE-TEC in future – regardless of industry or application.
Through this certification, our customers benefit from:
- increased process reliability
- complete traceability
- structured risk management
- stable and validated manufacturing processes
Quality for safety-critical electronics
With ISO 13485 certification, SE-TEC is positioning itself specifically as a partner for safety-critical electronics. We consistently apply the high standards of medical technology to other sectors, including:
- Railway and signalling technology
- Automation and industrial electronics
- Energy and power electronics
- Measurement technology and analysis systems
- Aerospace
Certified EMS partner for demanding projects
The combination of ISO 9001 and ISO 13485 underlines our commitment to manufacturing highly reliable electronic assemblies with process reliability – from prototype to series production.
Are you developing electronics for demanding or safety-critical applications?
Get in touch with us – we will support you from development through to series production.
Ihr Christian Neubus / Qualitätsmanager