Quality Policy

As Bioeksen Ar-Ge Teknolojileri A.Ş., we are committed to delivering reliable and rapid solutions in the fields of human health, animal health, and food safety through molecular technologies and our highly competent human resources. In line with this commitment:

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• We implement our Quality Management System in accordance with ISO 13485:2016 and ISO 9001:2015 standards, continuously monitor its effectiveness, and ensure its continual improvement.

• We design, manufacture, and validate our products in compliance with all applicable regulatory requirements, primarily (EU) 2017/746 (IVDR).

• We ensure quality across all stages of the product lifecycle through a risk-based approach.

• We effectively manage digitalization and data governance; we prioritize data integrity, information security, and confidentiality; and operate in compliance with KVKK (Personal Data Protection Law No. 6698) and (EU) GDPR (General Data Protection Regulation).

• We uphold customer satisfaction and trust through an ethical, transparent, and sustainable business approach.

• We utilize resources efficiently in line with sustainability principles and strive to create long-term value.

• We support the development of our employees and foster a safe and participative working environment.In order to support the company-wide implementation of our Quality Policy, we ensure that all employees understand the policy.

• We periodically review our Quality Policy to ensure its continued suitability.
   

We embrace quality as an integral part of our organization and conduct all our activities with a commitment to continuous improvement.