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Quality management

At TestLine Clinical Diagnostics s.r.o. we place the highest emphasis on the quality and safety of our products.
We are certified according to ISO 9001:2015 and ISO 13485:2016 standards, which confirm our commitment to quality management in the design, development, production and distribution of medical devices.
Since May 2022, we have been certifying our products in accordance with the requirements of EU Regulation 2017/746 (IVDR), thus ensuring their safety, performance and reliability on the European market.

Our quality policy is to ensure that we remain a competitive and growing company in a global environment, by delivering assured quality, achieving customer satisfaction, and fostering employee engagement in the company’s development.

Our quality objectives are as follows:

- to efficiently manufacture safe and effective in vitro diagnostic kits of the highest quality by applying the latest scientific findings and modern technologies.

- to meet or exceed customer expectations regarding product quality and the services provided.

- to continuously improve our processes, products and services.

- to secure resources for the company’s continued development through the introduction of new products, innovation of the existing portfolio, and the pursuit of sound business and human resource policies.

- to be an employer of skilled and dedicated professionals.

We measure, monitor and analyse the performance of our processes and products to identify opportunities for improvement. To support this, we employ a variety of tools and techniques, including statistical analysis, process mapping and flowcharting.

If we identify deficiencies in our processes or products, we implement corrective and preventive actions to eliminate them. We also take additional measures to ensure that the issue does not recur.

We continuously strive to improve our quality management system by applying best practices, benchmarking and other improvement initiatives.

We take a responsible and proactive approach to managing our environmental and social impacts.