Quality Policy

Edition 1 Bydgoszcz, 05/03/2019



Passio Human Microbiome Ltd. conducts processes related to the design, implementation and production of medical devices in the area of issues related to the intestinal microbiome.


Bearing in mind the quality of the products delivered, Passio Human Microbiome Ltd. has established, implemented and maintains a QUALITY MANAGEMENT SYSTEM based on the requirements of the PN-EN ISO 13485: 2016 standard, which guarantees continuous improvement of the quality of the carried out processes, the supply of high-quality products with a high level of security that meets the client’s requirements.


Thus, the conditions necessary for achieving the declared, continuously monitored, assessed and updated quality goal are created:


Providing customers with a high-quality product by following the accepted standards, rules and procedures, keeping in mind the safety and client’s expectations.


In order to achieve the goal set in the Management System Policy, the Management Board of Passio Human Microbiome Ltd. undertakes to:

• introducing from the offer and finally selling only products that will merit the recognition of customers by effectively meeting their needs and expectations, taking into account the applicable legal and other requirements applicable to the products, with particular emphasis on the results of risk assessment related to the manufacture of medical devices;
• continuous improvement of processes and the product itself in the interest of ensuring high quality, functionality and safety of our products, and increasing the level of sales;
• providing adequate resources and resources necessary to manufacture products about the expected quality, so that they are safe, effective in terms of using the product and for implementing this policy;
• employing highly qualified staff and constantly increasing its qualifications through a system of internal and external training;
• continuous improvement of the QMS;
• compliance with legal and regulatory requirements in force in the conducted activity;
• analysis of customer needs and assessment of satisfaction level;
• care of the company’s image and its promotion outside.


We achieve our goals thanks to the involvement of all employees of the company and people working on its behalf who are aware of the impact of their work on the quality and safety of the product.


This Policy has been agreed with employees and their representatives, communicated to all employees working in and on behalf of the organization and made public on the company’s website.


The Management Board of Passio Human Microbiome Ltd.



The quality policy has been communicated to all personnel through its inclusion in the Quality Book, on the company’s website and the Quality Policy and placed in public places for employees. The policy update is conducted during management reviews, during which decisions are made to modify it. Management effectiveness is also assessed during management reviews.