At Ethos biosciences, we are committed to developing and providing high-quality medical diagnostic products to our customers. We understand the importance of accuracy and reliability in medical diagnosis, and we are dedicated to meeting the needs and expectations of our customers while complying with applicable regulations and standards.
Our Quality Policy is based on the following principles:
- Customer Focus: We strive to understand and meet the needs and expectations of our customers by providing high-quality products that meet their requirements.
- Compliance: We are committed to complying with all applicable regulatory regulations and standards, including ISO 13485:2016, FDA 21 CFR 820, to ensure the products are safe, effective, and meet the highest quality standards.
- Continuous Improvement: We are committed to continually improving our processes and systems to ensure that we are providing the best possible products to our customers. We will regularly monitor and evaluate our performance to identify areas for improvement and take appropriate action to address them.
- Employee Involvement: We recognize that our employees are our most valuable asset and that their commitment and involvement are essential to our success. We will provide them with the training and resources necessary to perform their jobs effectively and encourage their active participation in our quality management system.
- Risk Management: We will identify, evaluate, and mitigate risks associated with our products to ensure that they are safe and effective.
We are committed to ensure that our Quality Policy is communicated, understood, and implemented throughout our organization. This policy will be regularly reviewed and updated to ensure its continued suitability and effectiveness.
ISO 13485:2016 Certification
The quality management system of Ethos Biosciences covers the design, manufacture and packaging of dye and chemical solution stains; general purpose reagents and specialty chemicals; and finished components used in medical applications. It has been been registered by Intertek as conforming to the requirements of ISO 13485:2016.
Food and Drug Administration Establishment
FDA Registration Number: 2247035