Quality Management & Certifications
Brüsch is certified to EN ISO 13485:2016 and ISO 9001:2015 by Bureau Veritas Certification Denmark, with both certificates renewed in 2026 and valid until 20-04-2029.
Brüsch operates under certified quality management systems designed to ensure repeatable manufacturing, full traceability, controlled documentation, and compliance with demanding customer and regulatory requirements.
Medical Device Quality Management
EN ISO 13485:2016
"Manufacturing, Including Process Development, and Assembly of Precision Parts in Metals, Alloys and Composites. For the Medical Devices."
- Certificate No.: DK020220
- Originally certified since: 21-04-2014
- Current certification valid until: 20-04-2029
- Certified by: Bureau Veritas Certification Denmark
Quality Management Systems
ISO 9001:2015
"Manufacturing, Including Process Development, and Assembly of Precision Parts in Metals, Alloys and Composites."
- Certificate No.: DK020219
- Originally certified since: 23-12-2011
- Current certification valid until: 20-04-2029
- Certified by: Bureau Veritas Certification Denmark
ISO 13485 in practice
What it means for your components
In practice, ISO 13485 means that Brüsch operates with:
- Full batch and material traceability
- Controlled documentation and revision management
- Validated and repeatable manufacturing processes
- Structured risk and change management
- Controlled non-conformance handling (NCR/CAPA)
- Medical-grade supplier and process control
- Inspection documentation including CoC, FAI, PPAP and MSA where required
This ensures customers receive stable, reproducible production with documented quality throughout the entire manufacturing lifecycle.
ISO 9001
Continuous improvement
ISO 9001 supports Brüsch's focus on continuous improvement, process stability, customer satisfaction, and efficient production management across all industries served.
Ready to discuss your next component?
Send your drawing or RFQ to sales@brusch.dk, and we'll make sure it reaches the right specialist.