Quality has to be at the centre of all of our activities. In this respect, every Company should have a Quality Management ethos, irrespective of whether the product is already licensed and marketed. It ensures compliance to the legislation as well as the implemented Company processes. It manages the training and understanding of those process and regulations and ensures the Company achieves a uniform standard globally.
That is why it is important and why in the EU legislation that Quality Management is Module No I because all other activities mentioned in the other 14 modules rely on the first Module working properly and being implemented effectively.