Quality

The foundation for Anatolia Geneworks’ high level of quality is the emphasis placed on ongoing development and improvement.

All employees of Anatolia Geneworks, whether they are fellow employees or distributors, go through thorough training, work to maintain quality objectives, and accept this as a necessary component of daily operations.

The most important and mandatory papers are the ISO 9001:2015, ISO 13485:2016 standards, Conformity to In Vitro Diagnostic Medical Devices Directive 98/79/EC, and CE certification. It is an honor for Anatolia Geneworks to possess these certificates.

These certifications serve as the foundation for Anatolia Geneworks’ work and are not framed documents for display. Rather, they represent obligations and promises that must be kept.

Being an R&D company, we place more value on training, personality, energy, discipline, and problem-solving innovative approaches of all associates than on any type of certifications and as the most crucial quality control.

Our trained and dynamic team, who have adopted the principle of customer focus and produce high-quality work with effort, embrace quality awareness, process approach, and risk-based thinking. We take into account the suggestions of our employees and emphasize the importance of their active contribution to the system, creating suitable and safe environment/working conditions for both personnel and product safety and performance. Emphasis on continual development and improvement forms the basis of our quality policy.

The top management of Anatolia Tanı A.Ş. determines and monitors quality objectives that are consistent with its strategic plan to achieve worldwide recognition and market share in the fields of molecular genetics and biotechnology through high products’ quality and performance, manage risks, and lead and guide their employees in identifying new opportunities and evaluating improvement possibilities.

The top management recognizes the importance of developing, implementing, and maintaining an effective Quality Management System that meets applicable regulations and customer requirements at every stage. The top management is aware of the responsibilities as a publicly traded company to conduct our activities within ethical rules and laws, taking into account the common interests of all stakeholders. We strive to add value to the field of molecular genetics and biotechnology for both our internal and external stakeholders, including shareholders, by continuously increasing our market share and activities at home and abroad.

Anatolia Tanı A.Ş. appreciates the functional working system that has been established through creative solutions, enabling us to operate effectively independently of individuals. We are committed to achieving our quality objectives and long-term success by adhering to ethical values and complying with the legal requirements, regulations, and customer and contractual conditions related to the TS EN ISO 9001:2015 standard, TS EN ISO 13485:2016 standard, In Vitro Diagnostic Medical Devices Regulation (EU 2017/746 IVDR), IVD Directive 98/79/EC (during the transition period), and Machinery Safety Regulation (2006/42/EC

With IVD-CE marked Real-Time PCR kits, nucleic acid extraction kits, rapid antigen test kits, and automated nucleic acid extraction instruments, Anatolia Geneworks creates turnkey diagnostic solutions that are safe for use in Türkiye and around the world. 

Anatolia Geneworks carries out its relevant operations in accordance with the ISO 9001:2015, ISO 13485:2016 standards, 98/79/EC directive, EU 2017/746 IVDR and 2006/42/EC regulations.  

Anatolia Geneworks became the first company in Türkiye to get IVDR certification for high-risk molecular diagnostic products.    

Some of the relevant documents are presented below.