Quality management

Quality Management

Our products are made and reach the market on an extremely high technological level of production process, the process of warehousing and logistics, as it has been confirmed by harmonizing our business with the requirements of ISO 9001:2008, ISO 13485:2012 and MDD 93/42 EEC with the directive of the EU.


The quality of our processes and overall operations of the company comply with the strict requirements of ISO 9001: 2008 and ISO 13485:2012. We do not consider compliance with any of the above mentioned standards merely as an obligation to satisfy the regulatory requirements for production of medical devices of the European Union and globally accepted standards of good practice, but those quality standards are incorporated into the overall philosophy of our business, vision, mission, values, goals and strategies. The quality of our products is determined not only by the strict requirements of MDD 93/42 EEC directives, but also with an extremely high technological level of the production process, warehousing process and process of transportation of products.

Processes, quality system and ISO 13485:2012

Kowlanatur has certified and aligned its business with the requirements of ISO 9001:2008, ISO 13485:2012 and MDD 93/42 EEC with the directive of the EU, and thus demonstrated a high level of doing business, and further commitment and guarantee that we would incessantly improve our business processes. That also implies that we have ensured stability and iterativeness in the way we make our products available to the clients. To be certified by above given standards, that is to establish a way in which we follow the risks and the way our products affect our clients. That also in turn means that we have defined and set up the way to process and analyze feedback from the market, so that we could constantly check what our clients think about us. Highly educated and professionally competent employees take care of these issues.
The efficiency of standards that are to be applied, our business operations, conducting defined procedures and other requirements of ISO 13485:2012, are regularly supervised by accredited body, as well as our many partners and principles.
Sal Maris, as well as our other products, meets rigorous requirements for product quality, defined through requirements for CE marking according to European Directive MDD 93/42 EEC. In all realms of our business, we have fully ensured the required conditions for production, warehousing and transport of products in controlled conditions. That includes cold chain, identification and traceability of each individual product, by its expiration date series, using cutting edge information and communication equipment. Apart from the established organization structure and quality system, high standards of production and preservation of product quality are ensured by digitized and automated production and warehousing capacities. The process of production of Sal Maris starts within a laboratory through a phase of analysis and continues through integration process of production and filling by a modern automated production line. The process of Sal Maris storage is digitized and automated, in compliance with EU directives and above mentioned standards, and further with a good warehousing practice and good practice in distribution of drugs and medicinal products.

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