Quality Policy
Senior Management Team has developed the following Quality Policy, which governs day-to-day operations to support quality. The Quality Policy is communicated and implemented throughout the organization.
The Quality Policy of UFC Bio is as follows:
UFC Bio is committed to providing products and services that meet customer requirements and applicable regulatory requirements. We maintain a quality management system aligned with ISO 13485:2016 and supported by cGMP principles where applicable.
To fulfill this commitment, we:
- Understand and meet customer, statutory, regulatory, and quality management system requirements.
- Maintain effective controls for product realization, purchasing, production, testing, release, storage, distribution, and records.
- Establish measurable quality objectives and review performance during Management Review.
- Use risk-based decision-making to protect product quality, patient/user safety, and compliance.
- Ensure personnel are trained, qualified, and aware of their quality responsibilities.
- Maintain the suitability, adequacy, and effectiveness of the QMS and implement improvements where appropriate.
The President ensures that the Quality Policy:
- is appropriate to the purpose of the organization,
- includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
- provides a framework for establishing and reviewing quality objectives,
- is communicated and understood within the organization,
- is reviewed for continuing suitability.