Our commitment to the quality ethics and performance of all our instruments is demonstrated by our accreditation to the International quality assurance standards of:
JFU Industries has implemented a quality management system, which has been certified ISO 9001:2008. This certification ensures that the company regularly delivers products that meet all customers’ needs and regulatory requirements. The management system has been audited by a UKAS accredited assessor and subject to surveillance audits to ensure ongoing compliance.
We are proudly an ISO 13485 certified company and 100% compliant with the quality criteria required by this medical device manufacturing standard which ensures that we meet the regulatory requirements for the quality of medical instruments, medical devices and the medical technology.
The key aspects that the ISO 13485 requires but is not limited to are following;
- Management responsibility to promote and create awareness of regulatory requirements.
- Work environment controlled to ensure safety of products.
- Throughout product development, continuous focus on risk management and design control activities.
- Traceability and specific requirements for inspection of medical devices.
- Documentation and validation of all processes for medical devices.
- Corrective and preventive actions requirements are effective and verifiable throughout the system.
This provides the assurance that products supplied by JFU Industries are in compliance with the crucial requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest principles of craftsmanship.