Quality Management System
HealthLink Europe has established, documented, implemented, and maintains a Quality Management System (QMS) in accordance with the requirements of all applicable standards and regulations. HealthLink Europe continually improves the effectiveness of its QMS.
HealthLink Europe's quality policy is directed to maintain and surpass the high standard of service that is necessary to comply with the demands of our customers. Quality is an integral part of our business objective and this quality is guaranteed by laying down a system of planned and systematic processes within the company. The requirements as stated in the Medical Device Directive 93/42/EEC and EN ISO13485:2003 are the framework for the Quality System. This makes quality an integral part of our business objective.
HealthLink Europe's QMS:
- Identifies the processes needed for its operations and their application throughout the organisation.
- Determines the sequence and interaction of these primary processes of a process-based QMS.
- Determines criteria and methods needed to ensure that both the operation and management of these processes are effective.
- Ensures the availability of resources and information necessary to support the operation and monitoring of these processes.
- Ensures monitoring, measurement and analysis of these processes.
- Ensures implementation of actions necessary to achieve planned results and continual improvement of these processes.
HealthLink Europe manages these processes in accordance with the requirements of all applicable standards.
