The In Vitro Fertilization Laboratory strives to ensure a high level of quality and safety in the provision of medical services. This document describes the quality policy of the laboratory based on the requirements and principles of the international standard ISO 15189 “Medical Laboratories. Specific quality and competence requirements”.
2. Objectives of the quality policy
– To ensure the safety and accuracy of all laboratory processes related to In Vitro Fertilization in accordance with the requirements of ISO 15189.
– Improving patient confidence by providing high quality services that are based on scientific principles and best practices.
– Improving patient satisfaction through active communication, counselling and provision of information on their laboratory results.
– Systematically updating and improving laboratory processes through monitoring and continuous improvement.
3. Core principles
– Competence and training: The laboratory shall ensure the competence of its staff by assessing and updating their knowledge, skills and competencies. Training is conducted in accordance with the requirements of ISO 15189.
– Security and ethics: The laboratory maintains strict ethical principles and is committed to protecting the confidentiality and security of patient data. Biological materials and test results are handled and stored according to established protocols and regulatory standards.
– Regular monitoring and auditing: The laboratory conducts systematic monitoring and internal auditing of its processes to detect possible discrepancies, identify problems, and take corrective action.
– Continuous improvement: The laboratory strives to continually improve its processes and services through data analysis, patient feedback, participation in external quality assessments and implementation of best practices.
4. Responsibilities of Management
The management of the IVF laboratory shall be the primary and responsible for the establishment, maintenance and continuous improvement of the quality policy and for its understanding and implementation at all levels of the laboratory. Management shall ensure that the quality policy is accessible and understandable to all personnel and shall provide the resources necessary to implement it.
The laboratory undertakes to comply with all requirements specified in the international standard ISO 15189 and to ensure their continuous compliance through regular updating and improvement of the quality management system.
6. Review of the quality policy of the IVF laboratory
The IVF laboratory quality policy is regularly reviewed and updated by management to ensure that it is up-to-date and consistent with the strategic and operational objectives of the laboratory.
7. Dissemination of the Quality Policy of the IVF Laboratory is available to all personnel of the laboratory and outside stakeholders who are authorized to access it. It shall be disseminated and made publicly available according to established procedures.
This quality policy is effective upon approval by management of the laboratory and should be binding for all levels of personnel to comply with and implement.
9. The quality policy will be reviewed and updated as necessary or if the requirements of ISO 15189 or other regulatory standards change.
The IVF laboratory reaffirms its commitment to high levels of service, compliance with ISO 15189 and continuous improvement of its activities.