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One of the main changes in ISO 9001:2015 is an increased emphasis on risk-based thinking as a cornerstone of quality management.

Risk-based thinking is not a new concept in quality management. It has long been a part of ISO standards and is a key consideration in project and process management. The 2015 revisions adhesive risk-based thinking as a continuing component to increase awareness of potential risks and increase attentiveness.

All businesses take risks and most business decisions involve some level of risk assessment. The change, for purposes of ISO 9001, is to rethink risk management as a part of your business process. Instead, ISO 9001:2015 includes a component of risk-based thinking, and it involves the people and leaders within your organization.


In fact, clause 5 of ISO 9001 now requires top management to encourage awareness of risk-based thinking and to address risks and opportunities that can affect product or service conformity.
Leadership must prove their commitment to quality management and be detained accountable for its effectiveness. Operations budgets should ensure that sufficient resources are available for risk assessment and monitoring. Again, the allocation of these resources should not be myopically viewed as burdensome expenditures, because when implemented properly, risk management can identify numerous opportunities. Risk-based thinking replaces what earlier version of the standard called preventive action.


ISO 9001:2015 employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. This means the organisation needs to:

1. determine required process inputs and expected outputs,
2. assign responsibilities and authorities for processes,
3. identify risks and opportunities for processes, and plan to address these.

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