Quality & Compliance Certifications
World Strong Rubber operates under globally recognized quality systems. Our certificates support medical, automotive, electronics and consumer-goods supply chains.
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Certifications & Compliance
Downloadable copies are available under NDA. Contact us for the latest audit reports and registration documents.
ISO
ISO 9001:2015
Quality Management System
End-to-end quality management covering design, purchasing, production, inspection and customer service for silicone and plastic components.
- Documented procedures and work instructions
- Management review and continuous improvement
- Customer complaint and CAPA process
13485
ISO 13485:2016
Medical Devices QMS
Certified quality system for the design, manufacture and distribution of medical-grade silicone catheters, drainage tubes, balloons and accessories.
- Risk management per ISO 14971
- Traceability and device history records
- Cleanroom production and EO sterilization
IATF
IATF 16949:2016
Automotive Quality
Automotive-sector quality system supporting silicone seals, gaskets, connectors and molded parts for OEM and Tier-1 suppliers.
- APQP / PPAP submission support
- Production part approval process
- Statistical process control (SPC)
FDA
FDA 21 CFR 177.2600
Food & Drug Contact
Silicone rubber compounds formulated and tested for repeated-use food-contact and medical-device applications under U.S. FDA regulations.
- Material composition control
- Migration and extractables testing
- US FDA master file support
LFGB
LFGB / EU 10/2011
Food Contact EU
Compliance with German LFGB and EU framework regulation 10/2011 for food-contact silicone and plastic materials.
- Overall migration testing
- Heavy metal and sensory tests
- Declaration of compliance available
ROHS
ROHS & REACH
Hazardous Substances
Restriction of hazardous substances in silicone and plastic products sold to the EU, supporting electronics and consumer-goods markets.
- Lead, cadmium, mercury restricted
- SVHC screening per REACH
- Test reports by third-party labs
Company Certification
Certified. Audited. On Paper.
Scanned certificates from our company profile — ISO 9001, ISO 13485, IATF 16949, ISO 14001, ISO 14064 and National High-Tech Enterprise.
Capability
Testing & Laboratory
In-house and partner-lab testing ensures every batch meets specification before shipment.
1
Dimensional
CCD vision, CMM and custom gauges for tight tolerances.
2
Mechanical
Tensile, tear, hardness, compression set and elongation.
3
Biocompatibility
ISO 10993 / USP Class VI cytotoxicity and sensitization.
4
Sterilization
EO sterilization validation and bioburden monitoring.
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Need a Certificate of Analysis or Audit Report?
Send your product requirements and we will provide the relevant certificates, test reports and compliance declarations.