Certified Quality Systems for Precision Silicone Rubber Project
These certifications support the way Fecision manages silicone material review, tooling validation, production consistency, inspection records, environmental responsibility, and customer documentation.
ISO 9001:2015
ISO 9001 helps organizations demonstrate that their processes and procedures achieve customer satisfaction and business goals. It ensures a company’s services or products are of high quality, efficiently produced.
- Standardized Process control
- Complete inspection traceability
- Continuous corrective improvement
ISO 13485:2016
ISO 13485 helps organizations establish a quality management system designed for medical device manufacturing and related services. It ensures products are designed and produced to meet customer expectations, regulatory requirements, and safety standards.
- Medical-grade quality control
- Risk management & traceability
- Regulatory compliance
IATF 16949:2016
IATF 16949 helps automotive organizations develop a quality management system focused on defect prevention, risk reduction, and continuous improvement. It ensures automotive products are manufactured with consistent quality, reliable processes, and compliance with requirements.
- Automotive process control
- Defect prevention system
- Continuous improvement
ISO 14001:2015
ISO 14001 helps organizations establish an environmental management system to effectively manage their environmental responsibilities. It ensures manufacturing activities are carried out with improved environmental performance and efficient resource utilization..
- Environmental control
- Resource management
- Regulatory compliance monitoring
ISO Class 7 Cleanroom
ISO Class Cleanrooms help organizations control airborne contamination levels through defined cleanliness requirements and environmental monitoring. It ensures sensitive products are manufactured in a controlled environment with reduced contamination risks.
- Controlled contamination levels
- Clean manufacturing conditions
- Environmental monitoring
GMP Certified
GMP helps organizations establish controlled manufacturing practices to ensure product quality, safety, and consistency. It ensures products are produced and tested under documented, hygienic, and validated processes.
- Controlled hygienic production
- Controlled handling
- Consistent product quality