Management System for Intramedullary Rod Production
Lip Hing Metal Manufacturing (Huizhou) Limited (Lip Hing) has been fabricating semi-finished metal parts for decades and has obtained ISO 9001 certificate in 2008. In 2017, it planned to expand into the medical devices market and explored the use of its fabricated metal parts for medical devices.
In this rapidly expanding landscape, re-design of the plant’s layout including production lines leaves Lip Hing with challenges and anxieties breaking into this brand new sector.
- Conduct actions under existing resources to appropriately plan and position employees, materials, machines, equipment, and other manufacturing supports and facilities to create the most effective plant layout
- Introduce 13485 concepts & requirements to staff and provide training to key staff
- Promote the awareness of regulatory requirements as ISO 13485 places strict requirements on the work environment
- Identify, evaluate and mitigate risks associated with harm to people and damage to property or the environment
- Document and record in language that will be easy to understand
- Designed and operated manufacturing facilities that can quickly and effectively adapt to fabricating medical devices
- Control of Work Environment to Ensure Product Safety
- Risk Management and Control
- Made sample templates and ISO 13485 audit checklist for Lip Hing for effective quality documentation and system implementation