I firmly believe that quality and ethics go hand-in-hand, and frankly it shakes some of my confidence on my profession when I read of organizations that supposedly subscribe to quality principles and standards (such as the ISOs) still not meeting the grade.
There are four widely accepted principles in biomedicine, which applies equally to medical devices and pharmaceuticals:
- Principle of respect for autonomy
- Principle of nonmaleficence
- Principle of beneficence
- Principle of justice
It seems a failure of ISO 13458 that adherence to this quality standard does not lead to results aligned to these four principles. It should surprise no one who knows me that this is one of the reasons I support strong regulations in this space.
- Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th Edition. New York: Oxford University Press, 2013