Doc Name:
Quality Policy
Doc Nº:
UDX-PO-00001-EN
Rev:
G01
Languaje:
English
Doc Type:
Policy (PO)
Doc Date:
19/05/2023
Release Date:
19/05/2023
Manager:
Chief Administrative Officer
Change History
Revision
Date
Aproval
Changes
001
02/11/2016
ALG, CHE
New document
002
04/05/2018
CHE
Added Multi-“omics” techniques
003
02/08/2019
CHE
Remove references to clinical lab; expand risk management to the different processes of the company.
G00
11/05/2021
CHE
Update to the new revision coding system adapted to thenew QMS software.
G01
05/19/2023
AL
Update UDX legal form from Universal Diagnostics S.L. to Universal Diagnostics S.A. Revision of the purposes, inclusion of vision, and mission of the company
Universal Diagnostics, S.A. (UDX) is an innovative biomedical start-up specialized in the development of diagnostic tests for the early detection of cancer and precancerous states using multiomics techniques.
Company ́s leadership is convinced that the main strategy to win the battle against cancer is its early detection. The Company ́s mission is to create a future where cancer is curable by reading even the earliest signals of cancer efficiently.
Moreover, their vision is to ensure that research, development, manufacturing, and marketing processes of IVD medical devices are performed with the greatest efficiency and effectiveness, striving for excellence.
Current certification of ISO 9001 plus ISO 13485 standard and FDA requirements will help UDX to ensure this main purpose of the leadership.
Hence, Company ́s leadership commits to fulfill the following purposes of quality policy:
Achieve customer's and stakeholders’ (patients, employees, physicians, investors, and collaborators) satisfaction, know and meet their expectations as well as respond to their needs.
Establish a high level of collaboration with suppliers, customers, and stakeholders such as investors, collaborators, and physicians.
Increase personal and professional satisfaction, promote teamwork in a suitable environment, and enhance training, raising awareness and involving all UDX’s personnel in the continuous improvement of processes and the achievement of objectives.
Eliminate or minimize the risks associated with the products/services/processes of the Company to provide customers and end users with the maximum level of safety.
Ensure compliance with legal and regulatory requirements applicable to the company, its products and services, and compliance with ISO 9001 standard.
Ensure continuous improvement of the Quality Management System (QMS) through the periodic review and adaptation of the objectives, indicators, and quality policy to maintain the effectiveness of the QMS and provide the safety
and effectiveness of their products.Ensure compliance with good professional practice, the performance of appropriate analyses according to their intended use, and the continuous improvement of quality.