1.5 - QMS Quality Risk Management

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.

Risk icons created by Chattapat.k - Flaticon