The concept of “risk” in the context of ISO 9001 relates to the uncertainty of achieving such objectives.
Risk is addressed in many of the Clauses as well as the Introduction, namely:
in the Introduction, the concept of risk-based thinking is explained
in Part 4, the Process Approach, the organization is required to determine the risks which can affect its ability to meet these objectives
in Part 5, Leadership, top management is required to commit to ensuring Part 4 is followed
in Part 6, Planning, the organization is required to take action to identify risks and opportunities
In Part 7, Support, the organization is required to determine and provide necessary resources, reducing the risk of producing/delivering defective product or service to an acceptable low level