Quality and Regulatory Policy
Last update: October 26th, 2018.
BIOPROGNOS is focused on ensuring that our medical devices meet the requirements and expectations of our customers and users, to ensure compliance with our contractual obligations, legal and regulatory requirements and enable continuous improvement of the Quality Management System (QMS) and its processes.
To achieve this objective, the strategy of company performance is based on the following principles and commitments:
- Ensure excellence in production quality of the manufactured products
- Understand and meet the needs and requirements of our customers
- Understand and meet our contractual obligations with suppliers and customers
- Maintain the effectiveness of the Quality Management System
- Ensure compliance with legal and regulatory requirements
The Chief Executive Officer (CEO) is responsible for defining, implementing and maintaining this Quality and Regulatory Policy for which Quality Manual and Quality Management System were established according to the requirements of:
- The UNE-EN-ISO 13485:2016
- European Directive 93/42/EEC and its amendment 2007/47/EC
- Transposition of the directive in legislation in Spain RD 1591/2009
- Requirements of the Competent Authority Health Authority
The effectiveness of the BIOPROGNOS’ Quality Management System depends on the unconditional support of all our employees. Staff should endorse the concern for quality, understanding the importance of each task performed to achieve the objectives.
The Quality is under the direct supervision of the CEO of the Company, thus, completely independent from the other departments or individuals involved in the production process. The access to the management level will allow the implementation of those procedures, revisions or corrective and preventive action deemed necessary for compliance with the Quality Management System.
The Quality Manager (task assigned to the Chief Quality & Regulatory Affairs Officer of the company), is entitled to propose changes in any activity that may not develop as defined in the Quality Management System.
The CEO establishes the necessary measures to ensure the dissemination of the Quality and Regulatory Policy in all areas of the Organization, pledging to be understood, implemented, reviewed and updated. This diffusion is done through talks with the various heads of the company.
The Executive Management defines the objectives of the company and its key components to achieve the previously points defined in the Quality and Regulatory Policy, awarding each department, the necessary authority and responsibility, by providing required human, technical and financial resources for the elements achievement of objectives.