As an international medical non-profit organization, Médecins Sans Frontières has set as a moral principle to provide its missions worldwide with Medical Devices and In Vitro Diagnostics of equivalent standards in terms of safety and performance as products available in Highly Regulated Countries to offer the best quality of care to its beneficiaries, as well as a safe working environment to its medical teams.
As legal manufacturer of In Vitro Diagnostics Medical Devices, the strategic objectives of The MSF Foundation are:
- To develop innovative products adapted to Low- and Middle-Income countries specific needs and risks, such as limited access to technologies, level of education and training of the end-users, patient’s clinical profile in specific epidemiological context
- To provide high quality, state-of-the-art products to the end-users
- To support end-users worldwide with appropriate trainings and a high level of customer service
- To improve the end-user experience based on customer feedback
This will be achieved by complying with and ensuring maintenance of the effectiveness of the ISO 13485 standard and the IVDD, and subsequently to the IVDR.
This will be translated into clear quality objectives that will be reviewed on a regular basis, at least once a year, by the management team and presented to all concerned employees during the annual management reviews.
To maintain a clear communication, this Quality Policy is displayed in this Quality Manual and throughout the organization.
The Quality Policy will be regularly reviewed by the management team, at least every two years, to confirm its suitability to the organization and will be adjusted if need be.
Special scrutiny will be applied for the first release of the quality policy to ensure that it is well understood and implemented by all concerned employees.
The management of The MSF Foundation is responsible:
- To monitor the implementation of the Quality Policy through an effective QMS,
- To monitor if the level of quality of the products is complying with relevant statutory, safety requirements and established standards,
- To monitor the communication of the Quality Policy throughout The MSF Foundation, to ensure that it is understood and implemented by all relevant staff,
- To implement a continuous improvement of the QMS,
- To ensure that the necessary resources are available to reach the defined quality objectives.