Company management has set the quality policy listed below and is committed to distributing the policy and ensuring that it is understood by all employees in the organization. The quality policy is the frame work from which the quality goals are determined. Company management is will post the quality policy to all employees. In addition, management will ensure that it is understood, implemented and maintained through the organization by means of training the company will guide it employees to behave as per the quality policy. The Quality Policy will be distributed to all levels of employees, from management downwards by means of regular training and meetings. The Quality Policy will be reviewed during the Management Review to ensure that it is
suitable for the company goals and activities.
Laserlux Medical has been audited by the FDA, BSI and others with great success
Quality Assurance Activities:
- Customer Order Review
- Opening a DHR (Device History Record)
- Incoming visual inspection
- In-process microscopic visual inspection
- In-process functional test, if required (using customer’s test equipment)
- Final microscopic visual inspection
- Final functional test, if required (using customer’s test equipment)
- Batch release and quality certification
- Quality Record retention
QMS processes:
- Risk management
- Training and Re-training on various issues
- Calibration and maintenance of the equipment
- Validation and qualification for the special processes and facilities
Premises control:
- Clean rooms’ and control environment monitoring
- Annual re-qualification of clean rooms
- Pest control program
- Laser machine output verification by calibrated equipment
- Laser safety check-ups
Special test services:
- Dimension verification
- Wire bonding pull test – tension machine
- Dye test for sterile barriers – blisters and pouches
