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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