Pathomation Quality Statement

Pathomation bv is a Digital Pathology software developer and manufacturer. Pathomation commercialises products for Educational, Research and Diagnostic IVD use and provides custom development and expert project services for OEM companies and the Pharmaceutical sector. Pathomation is active in the promotion, marketing and commercialisation of its products to end users, direct or through distributors, around the globe and provides scientific and technical support.

Pathomation strongly believes that digital pathology will reduce laboratory expenses, boost operational efficiency, enhance productivity, aid in better treatment decisions and ultimately improve patient care. We are convinced that digital pathology is the future for diagnostic consultations, primary and intraoperative diagnosis, medical student education, resident training, diagnostic decision support, peer review, manual and semi quantitative review of immunohistochemistry (IHC), and tumor boards.

“Quality” for the company is the dedication to the goal which is delivering best in class digital pathology software with the needs of the customer put central. Our software is robust with the highest degree of interoperability. Our customer service is responsive and meets the expectations of our users Doctor, Lab Scientist, Researcher and Teacher. Pathomation is committed to provide its employees with the necessary tools and knowledge required to deliver the company goals.

To achieve the aforementioned goal, the company is committed to:

• • strict adherence to the rules of Ethics, Law and Proper Operation.
  • the compliance of its products / services with the applicable legislative and regulatory requirements in Belgium and abroad.
  • the high quality of its products / services. Specifically best in class software with high interoperability that is robust and secure.
  • The complete, immediate and systematic coverage of the needs of its customers.
  • the timely delivery of products according to agreed customer specifications.
  • the maintenance of customer installations in such a way as to ensure their continued operation and functioning according to specifications.
  • the scientific support of the products and the provision of all relevant instructions on their use.
  • the prevention or immediate treatment of possible mistakes.
  • the continuous training of staff.

In order to achieve the above, the Management of Pathomation bv:

• • Establishes measurable objectives for quality at corporate and departmental level, which it closely monitors through management reviews.
  • Has developed and installed a Quality Management System (QMS) in accordance with  the ISO 13485:2016 standard regarding medical devices.
  • Acquires ‘Diagnostic Use’ certification for markets (CE-IVD in the EU and FDA 510k for the USA)
  • It recognizes and provides all the necessary resources to meet the needs of the company both in human and logistic level, in order to ensure its smooth, efficient and effective operation.
  • Promotes continuous information and training of its executives.
  • Continuously monitors and measures critical parameters and processes to ensure the quality and safety of facilities, products/services and personnel.
  • It strives to achieve continuous improvement of its products/services, processes and Quality Management System.

The Management of the company appoints its representative for quality issues, the Quality Manager Mrs. Veerle Persy, with main responsibility the development and maintenance of the Quality Management System.

The company’s management is committed to the implementation of this quality policy.