Quality Management DIN EN ISO 9001:2015
Certificates
Our quality management
SE-TEC GmbH is certified to DIN EN ISO 9001:2015 and DIN EN ISO 13485:2021-12. Our quality management system is firmly established, effective and uncompromisingly focused on consistently reliable product outcomes – particularly for safety-critical electronics.
DIN EN ISO 9001 & ISO 13485 Certification of SE-TEC GmbH
Always on the safe side with certified quality
- Certified quality in accordance with ISO 9001 and ISO 13485
- Highest standards in process reliability, traceability and documentation
- Validated manufacturing processes for reproducible results
Continuous development of the QM system
- Increased efficiency through ongoing optimization of processes and procedures
- Technical modernization through regular investment in machinery and equipment
- Involvement of customers, suppliers, and employees as key components of system improvement
Risk and opportunity management
Using forward-looking prevention and risk management processes in accordance with ISO 13485, we identify, analyse and assess risks and opportunities at an early stage.
Our manufacturing is thus continuously adapted to current requirements and remains consistently stable and manageable.
Seizing opportunities, avoiding risks – consistently stable quality.
Exploiting opportunities, avoiding risks – consistently stable quality.
Process reliability
Quality and safety down to the last detail
Thanks to the enhanced requirements of ISO 13485, we guarantee:
- Full traceability
- Structured and documented processes
- High process stability, even for complex assemblies
- Ensuring product quality throughout the entire lifecycle
Your tangible benefits
- Reliable quality thanks to a certified QM system in accordance with ISO 9001 and ISO 13485
- Predictable processes through documented procedures and validated manufacturing
- Enhanced safety through structured risk management and full traceability
- Future-proof products through continuous improvement and technological advancement
The best quality for your products — you can count on us.
The combination of ISO 9001 and ISO 13485 underlines our commitment to manufacturing electronic assemblies with the highest quality and process reliability – from prototype to series production.
Frequently asked questions (FAQ) about quality management at SE-TEC
What certifications does SE-TEC hold?
SE-TEC is certified to DIN EN ISO 9001:2015 and DIN EN ISO 13485. As a result, the company meets recognized requirements for quality management, process reliability, documentation, and continuous improvement.
These certifications confirm our high quality standards in the manufacture of custom electronic assemblies.
What does ISO 9001 mean in electronics manufacturing?
ISO 9001 is an internationally recognized standard for quality management systems. In electronics manufacturing, it stands for standardized processes, documented procedures, continuous improvement, and a systematic focus on customer requirements.
On this basis, SE-TEC ensures consistent quality and stable manufacturing processes.
What does ISO 13485 mean for the manufacturing of electronic assemblies?
ISO 13485 is a quality management standard for medical devices and medical technology applications. It sets higher requirements for risk management, documentation, traceability, validation, and process control.
At SE-TEC, certification not only strengthens projects in the medical technology sector but also raises production standards for other demanding industries.