Certified quality. Trusted manufacturing.
Noriaz Instruments manufactures under ISO 13485, with CE-marked products, an FDA-registered facility, and mill certificates available per production lot, documentation your compliance team can rely on, not just marketing copy.
Quality that's documented, not just claimed.
Every instrument leaving our Sialkot facility is manufactured under a quality management system aligned to ISO 13485, with CE marking on qualifying product lines and an FDA-registered establishment on file. It's the same framework we'd want to see if we were the ones auditing a supplier.
Documentation is available on request for every order, not reserved for large accounts, because the buyers who rely on it most are often placing their first trial order.
Quality management
Production runs under an ISO 13485-aligned quality management system.
Regulatory compliance
CE marking on qualifying products, FDA establishment registration on file.
Material traceability
Mill test reports available per production lot on request.
Continuous improvement
Inspection findings feed back into process and finishing standards.
What's on file, and what it covers.
ISO 13485:2016
Our quality management system for the design and manufacture of medical devices, including surgical instruments, is aligned to ISO 13485:2016.
CE Marking
Qualifying product lines carry CE marking for conformity with applicable European market requirements, with technical files prepared in-house.
FDA Registered Facility
Our manufacturing establishment is registered with the FDA, on file for buyers who need it as part of their US import documentation.
Mill Test Certificates
Every instrument is milled from certified 410, 420 martensitic or 316L austenitic stainless, with mill certificates available per production lot.
How the certifications hold up in practice.
Consistent manufacturing process
The same six-stage process, material selection through export inspection, runs on every order regardless of size.
Inspection at multiple stages
Dimensional checks against master gauges during CNC milling, plus 100% functional inspection before packing.
Full documentation
Mill certificates, CE technical files and certificates of origin prepared in-house for each shipment.
Customer-specific requirements
Private-label and OEM orders go through artwork and specification proofs before production begins.
What this means for your order.
Certifications only matter if they change what shows up at your dock. Here's what they translate to on a standard order.
- Consistent product quality across every container, not just the sample batch
- Reliable manufacturing under a documented quality management system
- Paperwork ready ahead of time, so customs clearance isn't the bottleneck
- Material certificates available to satisfy your own compliance audits
Documents available on request.
Certificates and mill reports are issued per order and production lot. Contact us to receive current copies for your account.
CERTIFICATE
ISO 13485:2016
OF CONFORMITY
CE Marking
REGISTRATION
FDA Registration
REPORT
Material Certificate
Quality you can trust.
Need certificates or documentation for a compliance review? Send us your order details and we'll prepare what your team needs.
