Bioxodes is committed to provide safe and effective products and services to patients. To meet this commitment, Bioxodes maintains a robust Quality Management System to ensure products are developed, manufactured, distributed and used in compliance with the regulatory requirements.
Our QMS applies to all employees, at all levels of Bioxodes. The QMS ensures that the specific rules for each of the different areas are clear and at the right level of activity and that compliance is achieved at each step of the product life-cycle, without creating complexity.
To achieve a high level of quality, Bioxodes commits to ensure that:
- Bioxodes’ activities are conducted in compliance with applicable regulations, codes and standards.
- Procedures are in place for all its activities that adequately define the expectations for work that support product quality and/or data supporting product quality and patient safety.
- All employees and collaborators have the appropriate education, training, skills and experience to carry out their work competently, in accordance with applicable regulations and Bioxodes’ policies and procedures.
- Records, documentation and data are managed in accordance with applicable regulations. Processes for escalating issues to ensure product integrity and patient safety are in place and consistently used.
- There is an effective and appropriate oversight of any vendors carrying out work on behalf of Bioxodes.
- Performance is monitored and regularly reviewed to ensure our standards of conduct meet our high expectations of quality for our patients and stakeholders.