Quality
Quality Policy
Last updated: May 15th, 2026
At BioinGentech, we are committed to the design, development, production, and commercialisation of PCR kits, ensuring safe, reliable, and high-performance products that meet our customers’ requirements, market needs, and applicable regulatory standards.
To fulfil this commitment, the organisation establishes the following principles:
- Maintain and implement a Quality Management System based on the requirements of ISO 9001 and ISO 13485, promoting continuous improvement of processes and system effectiveness.
- Ensure the quality, safety, efficacy, and traceability of PCR kits throughout all stages of their lifecycle: design, development, production, storage, distribution, and after-sales support.
- Comply with applicable legal, regulatory, and normative requirements for medical devices and molecular biology products.
- Promote a culture of quality based on risk management, error prevention, process-based thinking, and continuous improvement.
- Ensure staff competence, training, and commitment, fostering responsibility, ethics, and good manufacturing and laboratory practices.
- Maintain effective relationships with suppliers and strategic partners to ensure the quality of raw materials, supplies, and critical services.
- Direct our activities toward customer satisfaction, guaranteeing timely support, technical assistance, and effective response to complaints or non-conformities.
- Design and development of customised PCR kits in accordance with customer requirements and specifications.
Management is committed to providing the necessary resources for the implementation, maintenance, and continuous improvement of the Quality Management System, ensuring that this policy is communicated, understood, and applied at all levels of the organisation.
This policy complies with current regulations and is reviewed by Management to ensure its understanding and application.
Contact Information
For inquiries or suggestions regarding our quality practices, please contact: