Certified for ISO 13485 Electronics Manufacturing, 4E are committed to providing the highest quality products and services to our clients.
ISO 13485:2016 is the International Standard for the Manufacture of Medical Devices. The standard requires more attention to regulatory requirements than ISO 9001 and here at 4E we are proud to hold this accreditation.
ISO 13485:2016 focuses 4E’s attention on:
- Regulatory Requirements
- Client Requirements
- Risk Management
- Legal Compliance
- Traceability and Recall
- Process Improvement
- Operational Efficiency
Quality is a company wide responsibility. We support this with our Quality Management System Manual, strong relationships with our Preferred Suppliers, and our production team who are committed to Continuous Improvement throughout the manufacturing process.
Not a medical or defence product? Our accreditation covers all our build processes and procedures, and no matter what your end product may be, it will receive the same assurance of exceptionally high quality.
“Quality is principle to everything we do here at 4E”