Traceability & Documentation
Full material and batch traceability throughout the manufacturing process, from incoming raw material through production, inspection and final delivery.
Traceable by default
From raw material to delivery
Brüsch maintains full material and batch traceability throughout the manufacturing process, from incoming raw material through production, inspection and final delivery. Production and quality records are securely stored and retained in accordance with our ISO 13485 and ISO 9001 Quality Management System, applicable regulatory requirements, customer-specific requirements and GDPR.
For medical device applications, documentation is retained in accordance with the applicable requirements of the EU Medical Device Regulation (MDR), including retention periods of at least 10 years and, where applicable, 15 years for implantable devices.
Material certificates are linked to the relevant production batch, enabling the material used for a specific component or order to be traced back to its original material documentation. In-process and final inspection results can likewise be documented and linked to the applicable production batch.
10 years
Minimum documentation retention under EU MDR
15 years
Retention for implantable devices, where applicable
Every batch
Material certificates linked to the production batch
Documentation package
Available on request or by standing agreement
Depending on customer, product and regulatory requirements, Brüsch can provide a comprehensive documentation package on request or by standing agreement, including:
- Certificate of Conformance (CoC)
- Material Certificates
- First Article Inspection (FAI)
- Production Part Approval Process (PPAP)
- Measurement Reports
- Control Plans
- Process Flow Charts
- Process Capability Index (Cpk)
- Measurement System Analysis (MSA)
- Gauge Repeatability and Reproducibility (GR&R)
- Failure Mode and Effects Analysis (FMEA)
- Process Failure Mode and Effects Analysis (PFMEA)
Documentation requirements can be defined during the quotation and qualification process, ensuring that the required level of documentation, traceability and regulatory compliance is incorporated from the beginning of the manufacturing process.
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Quality & Compliance
Quality Management & Certifications
EN ISO 13485:2016 and ISO 9001:2015, certified by Bureau Veritas Certification Denmark and valid until 2029.
Read more →Data Security & Confidentiality
NDAs as standard, secure data management, need-to-know access and GDPR-compliant handling of customer information.
Read more →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.