SmartHEN’s Quality Policy aims to ensure that all medical products designed, manufactured, and marketed meet the expectations of our customers and users, fulfill our contractual obligations, and comply with the legal and regulatory requirements—both general and specific—of our activity. It also seeks to ensure the continuous improvement of processes and the Quality Management System (QMS).

To achieve this objective, the company’s strategic approach is based on the following principles and commitments:

• Ensure excellence in the quality of the designed, manufactured, and marketed products.
• Understand and satisfy the needs and requirements of our customers.
• Understand and fulfill our contractual obligations.
• Maintain an effective Quality Management System.
• Ensure compliance with applicable legal and regulatory requirements.

Senior Management assumes the responsibility for defining, implementing, and maintaining this Quality Policy and, for that purpose, has established a Quality Management System in accordance with the requirements of:

• Current standards EN-ISO 13485
• European Regulation EU 2017/745 on medical devices
• Transposition of the directive into Spanish legislation through RD 1591/2009
• Requirements of the Spanish Agency of Medicines and Medical Devices (AEMPS)

The effectiveness of SmartHEN’s Quality Management System depends on the unwavering support of all employees. Therefore, staff members take ownership of quality, understanding the importance of their tasks and how the collective effort enables the achievement of objectives.

The Quality Manager reports directly to Senior Management, remaining fully independent from other departments or individuals involved in the production process. This direct access to management enables the Quality Manager to propose the implementation of any procedures, reviews, or corrective/preventive actions deemed necessary for the implementation and maintenance of the Quality Management System.

Senior Management ensures the dissemination of the Quality Policy throughout the company, committing to its understanding, application, regular review, and update.

Senior Management also defines the company’s specific objectives and the key elements to achieve them according to this Quality Policy. Each department is assigned the necessary authority and responsibility, along with access to the human, technical, and financial resources needed to accomplish the objectives.