Dear Sir or Madam,
We are pleased to inform you that, as of 12 April 2024, we have implemented a Quality Management System for medical devices compliant with PN-EN ISO 13485:2016, which is integrated with the Quality Management System compliant with PN-EN ISO 9001:2015, implemented on 11 July 2022.
The system implementation procedure and the first internal audit were carried out in cooperation with the Institute for Quality Management Training from Kraków.
The overriding objective of the Quality Policy established by the Research and Development Department of the Salmonella Center IMMUNOLAB Ltd. is to manufacture high-quality, safe products that are always compliant with the applicable statutory requirements.
The company’s development strategy includes continuous improvement aimed at increasingly better meeting the needs and requirements of customers in the field of manufacturing antisera for slide agglutination of Salmonella bacteria and rabbit plasma for coagulase detection.
We intend to implement this Quality Policy through:
- customer orientation and support by identifying market requirements, carefully analysing those requirements, ensuring their fulfilment and monitoring customer satisfaction,
- full involvement of our employees, as well as improving their qualifications and building their awareness of safety, quality and responsibility for the activities they perform,
- the use of effective tools for monitoring and tracking the performance of our Quality Management System,
- ensuring appropriate infrastructure and working environment,
- cooperation with qualified suppliers offering raw materials and materials of appropriate quality.
The Management Board and employees of IMMUNOLAB Ltd.
