Quality & Compliance

Sebia operates in a highly regulated worldwide environment, with a set of requirements that are increasingly demanding. While meeting those, Sebia does rely on Management Systems designed to improve our customers’ satisfaction, to meet regulatory requirements all over the World and to lead to business efficacy.

Quality and Compliance are deeply integrated into the Company’s culture and operations.

Sebia is structured around fundamental and closely interconnected processes. Among them: Management Control, Environmental Program, total Product Life Cycle, Customer Focus (Needs, Care and Distribution Network), Regulatory Watch and Product Submissions, Post Market Surveillance and Vigilance, and Resources Management.

The main components of our Quality Management System are:

• Total customer satisfaction
• Implementation by all employees
• Process and risk-based activities
• Fully integrated system
• Business-driven approach
• Continuous improvement
• Efficient information and communication

Sebia implements a stringent policy of control and traceability throughout the production and distribution chains. This provides our customers a high and constant quality of products and services, as well as the capacity for Sebia to communicate quickly and efficiently any relevant product information.

During the Design Control process, the devices are verified &/or validated according to all applicable standards.

All Sebia In Vitro Diagnostic devices are CE marked and registered in many countries around the World depending upon our business geographic footprint.

Sebia’s Quality Management System is ISO 13485:2016 certified and complies with the requirements of the MDSAP.

Anti-Corruption Program

All Sebia group employees are expected to follow the Sebia Anti-Corruption Program. The program is outlined below and built around recommendations of the French Anti-corruption Agency:

Code of Conduct

All employees and partners of the Sebia group are expected to follow ethical practices in accordance with the values of the group.

Sebia Code of Conduct outlines the risks related to corruption and describes behaviors expected to mitigate those risks.

Employee Training Program required for all group employees helps to raise awareness and understanding of how to handle unethical practices.

Third Party Assessment
A procedure for evaluating third parties in order to identify and assess the risks of corruption likely to arise when entering into a relationship with new partners.

Reporting an unethical practice
Sebia has in place a whistleblowing procedure explaining how employees and other Sebia’s stakeholders can report concerns about suspected unethical practices without fear or retaliation through the platform: www.ethicorp.com/sebia