ISO 13485 Medical Devices – Quality Management System
ISO 13485 specifies requirements for a Quality Management System that can be used by an organisation involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning, disposal of medical devices, and provision of associated activities.
And our certification on ISO 13485 can also be used by suppliers or other external parties providing product such as raw materials, components, sub assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services to such organisations.
ISO 13485 also adopts a risk management approach which includes assessment to identify and estimate risk. It uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.
BENEFITS OF ISO 13485
- Trust in being a safe supplier and producer
- Likelihood of meeting customer requirements and expectations
- Reduce operation cost and production loss rate
- Improve processes based on objective measurement
- Increase competitive advantage
- More effective risk management