Case Sharing

Lip Hing Metal Manufacturing (Huizhou) Limited

Provide ISO 13485 Medical Devices QMS Consultancy

Industry: Manufacturing, Medical Devices production

Service: Medical Devices Quality Management Systems 

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Incorporated in 1977, Lip Hing Metal Manufacturing (Huizhou) Limited (Lip Hing) designs and manufactures different kinds of moulds, provides professional stamping processing, and processes metalwork with high-precision machining equipment.

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 medical devices market and explored the use of its fabricated metal parts for medical devices.

Although decades of fabricating semi-finished metal parts, Lip Hing knows little about medical devices, much less about ISO 13485. In this rapidly expanding landscape, re-design of the plant’s layout including production lines leaves Lip Hing challenges and anxieties breaking into this brand new sector. 

Project Scope

  • 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 trainings to key staff

  • Promote the awareness of regulatory requirements as ISO 13485 places strict requirements on 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

Appreciation letter from LHM

“…experienced and exceptionally professional, providing us clear directions and assisting us ….to fulfill all requirements in ISO 13485:2016.”

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