How to implement risk management in ISO 9001:2015 · PDF fileHow to implement risk management...

How to implement risk management in ISO 9001:2015

Presenter: Strahinja Stojanovic

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What is risk-based thinking (RBT) and how do you apply it?

If you are planning a transition to, or just starting the implementation of ISO 9001:2015…

...you can save a lot of time if you approach RBT systematically.

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Risk -based thinking was always present; it just wasn’t called by

that name.

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• Risk-based thinking process• Choosing the best technique• Business impact analysis (BIA)• Fault tree analysis (FTA)• Failure mode effect analysis (FMEA)• Documenting and evidencing the RBT• Main challenges

Agenda

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• Define the scope• Adopt the methodology• Conduct the risk assessment• Mitigate the risks• Follow up

Risk -based thinking process

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• Context of the organization• The type and range of risks being analyzed

• The availability of information and data• Regulatory and contractual requirements

Choosing the best technique

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• Use• Strengths• Limitations

Business impact analysis

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• Use• Strengths• Limitations

Fault tree analysis

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• Use• Strengths• Limitations

Failure mode effect analysis

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• What the standard requires• Should we document it?• How to provide evidences of RBT

Documenting and evidencing the RBT

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• Defining the scope of the risk assessment

• Selecting a risk assessment technique

• Conducting a risk assessment• Auditing the risk-based thinking

Main challenges

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•Defining the scope of the risk assessment

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Conclusion

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Examine the context of your organization and choose the best

technique for you .

Risk -based thinking is continuousand ensures greater knowledge and

preparedness.

Strahinja Stojanovic

Q & A

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