ISO 9001:2015 Quality Management System standard requires ‘risk-based’ approach embedded in the activities of
organization. The main theme is to examine the relevant “risk” during planning, execution and before deciding a
solution to a problem. Risk assessment provides a mechanism for identifying risks which represent opportunities or
potential pitfalls. Risk assessment process empowers management to better identify, evaluate, and exploit the right
risks for their business, while maintaining the appropriate controls to ensure effective and efficient operations and
regulatory compliance. Risk management enables an organization to consider the potential impact of all types of risks on all processes, activities, stakeholders, products and services.

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