COMPANY POLICY
QUALITY AND CORPORATE RESPONSIBILITY POLICY
Mission and Responsibility
ELISABETH PHARMACON is a manufacturer of in vitro diagnostic medical devices (IVDs), an operator of an accredited medical laboratory, and a provider of specialised healthcare services. The company also acts as an importer and distributor of products intended for clinical and research facilities.
The company’s activities are based on responsibility towards patients, customers, business partners, employees, and society as a whole. The fundamental principle is to ensure safety, professional integrity, and regulatory compliance in all areas of the company’s operations.
The company’s responsibility is to contribute to safe, accurate, and reliable diagnostics supporting appropriate clinical decision-making and the protection of patients’ health.
Laboratory activities are focused on patients and their safety. The laboratory takes into account the clinical context of examinations, strives to minimise risks to patients throughout all stages of the laboratory process—pre-examination, examination, and post-examination—and supports the correct and timely clinical interpretation of results. Quality objectives reflect the needs of patients, healthcare professionals, and other customers.
Commitment to the Quality of Products and Services
Quality is understood as a systematically managed process based on professional competence, accuracy, and responsibility.
The company is committed to:
- developing and manufacturing IVD medical devices that are safe, analytically validated, and clinically beneficial;
- providing laboratory services with an emphasis on professional standards, impartiality, accuracy, and timely delivery of results;
- maintaining controlled and validated processes throughout all stages of the product life cycle, from design and development to post-market surveillance;
- systematically evaluating customer feedback and other relevant data and implementing effective corrective and preventive actions.
Quality is the responsibility of every employee and forms an integral part of the company culture.
As part of post-market surveillance, the company ensures the systematic collection and evaluation of information concerning the performance and safety of its products, the management of complaints, and, where applicable, procedures for reporting and addressing serious incidents in accordance with applicable requirements.
Regulatory Compliance and the Management System
The company maintains and develops an integrated management system that ensures the systematic management of quality, safety, impartiality, and responsibility in all areas of its activities.
The management system complies in particular with:
- the requirements of EN ISO 13485:2016 applicable to medical device manufacturers;
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR);
- the requirements of EN ISO 15189:2023 applicable to medical laboratories;
- applicable legal and regulatory requirements.
The company is committed to complying with the requirements of EN ISO 13485:2016 and EN ISO 15189:2023, all applicable legislative and regulatory requirements, and to continually improving the effectiveness of the management system.
The company cooperates with the relevant competent authorities and notified bodies and ensures the continued compliance of its products and services with applicable requirements. Top management regularly reviews the effectiveness of the management system and establishes measurable quality objectives. This Quality Policy provides a framework for establishing and reviewing these measurable quality objectives at all relevant levels of the company.
The company, including the laboratory, applies the principle of continual improvement. The results of internal audits, risk management activities, nonconformities, complaints, external quality assessment (EQA), and the monitoring of quality indicators are regularly evaluated during management reviews and used to plan improvement measures.
Risk Management and Product Safety
Risk management is an integral part of the company’s management system and is applied throughout all key processes.
Risks are systematically identified, analysed, evaluated, and controlled, particularly:
- in the design, development, and manufacture of IVD medical devices;
- in the provision of laboratory services;
- in the monitoring of product performance after products have been placed on the market;
- in the area of information security and data protection;
- in relation to environmental impacts.
Relevant data, including customer feedback, monitoring results, and internal audit findings, are continuously evaluated. Appropriate corrective and preventive actions are implemented on the basis of this information.
The objective of risk management is to minimise the occurrence of nonconformities, incidents, and adverse events and to improve the safety, effectiveness, and reliability of products and services.
Information Security and Impartiality
The protection of personal, sensitive, and business information is a fundamental prerequisite for maintaining the company’s trustworthiness.
Information is protected against unauthorised access, loss, damage, or misuse. Information security risks are systematically identified, evaluated, and controlled.
Laboratory activities are performed impartially, objectively, and without conflicts of interest. Measures are implemented to ensure professional integrity and the independence of decision-making processes.
Every employee is responsible for complying with information protection, confidentiality, and ethical requirements within the scope of their role.
The company systematically identifies, evaluates, and controls risks to the impartiality of laboratory activities, including potential commercial, financial, or personal influences. Laboratory management ensures that no relationships or decisions compromise the objectivity of examination results.
The integrity, accuracy, availability, and traceability of laboratory records and electronic data are ensured throughout their life cycle, including the management of changes to information systems supporting laboratory processes.
Environmental Responsibility
The company is aware of the impact of its activities on the environment and the working environment, particularly in connection with the handling of biological materials and chemicals and the operation of technological equipment.
Measures are implemented to:
- minimise the environmental impact of manufacturing and laboratory processes;
- ensure the responsible management of waste and hazardous substances;
- reduce the energy intensity of operations;
- use resources efficiently;
- prevent pollution and undesirable environmental impacts.
Environmental risks are systematically evaluated and controlled in order to support the principles of long-term sustainable development.
Commitment of Company Management
Top management is responsible for the implementation, maintenance, and development of the integrated management system covering quality, information security, and environmental responsibility.
Company management is committed to providing sufficient personnel, technical, infrastructure, and financial resources for the effective operation, maintenance, and continual improvement of the management system in accordance with the requirements of EN ISO 13485:2016, EN ISO 15189:2023, and applicable regulatory requirements.
The provision of the necessary resources, the establishment of measurable quality objectives, and the regular review of the effectiveness of the management system are ensured.
Company management ensures that all personnel are competent to perform their assigned activities and have access to appropriate training and regular competency assessments. An open safety culture is promoted in which the reporting of nonconformities, incidents, and risks is regarded as an opportunity for improvement rather than a reason for sanctions.
Company management ensures that this Policy is communicated to all personnel by appropriate means, that they understand it and apply it in their daily work, and that it is regularly reviewed for its continuing suitability and effectiveness. The Quality and Corporate Responsibility Policy forms part of the controlled documentation system and is maintained in its current version.
Quality, safety, impartiality, and responsibility are the core values of ELISABETH PHARMACON and represent the company’s long-term commitment to patients, customers, and partners.
prof. RNDr. Omar Šerý, Ph.D. Markéta Raclavská, MSc.
Executive Director Quality Manager
ELISABETH PHARMACON ELISABETH PHARMACON
Date of issue: 31. January 2026
ELISABETH PHARAMCON, spol. s r. o.
Rokycanova 4437/5, BRNO-ŽIDENICE 615 00