EN ISO 13485:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes
This standard contains criteria for the whole scope of the medical devices quality management system.
The certificate according to EN ISO 13485:2012 standard covers the whole system of management of the organisation manufacturing or supplying medical devices and appropriate services.
Benefits of the quality management system certification according to EN ISO 13485:2012
- Demonstration of commitment to meet legal and regulation requirements
- Guarantee of constancy of a production process and thus of a stable and high quality of services rendered and products supplied to customers
- Demonstration of suitability, efficiency and effectiveness of the implemented quality management system by a third independent party
- Increase in quality of the management system, improvement of the organisation's organisational structure
- Improvement of order and an increase in effectiveness in the entire organisation
- Optimisation of costs - reduction in operating costs, decrease in costs of non-conforming products, savings in raw-materials, energy and other resources
- Increase in confidence of public and state control bodies in manufacturer of medical devices