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To explain the concept of risk-based thinking in ISO 9001:2015

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Developed by the ISO subcommittee responsible for ISO 9001 Available for unrestricted public use

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Risk-based thinking is something we all do automatically and often sub-consciously to get the best result The concept of risk has always been implicit in ISO 9001 – this edition makes it more explicit and builds it into the whole management system Risk-based thinking ensures risk is considered from the beginning and throughout Risk-based thinking makes preventive action part of strategic and operational planning

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Where is risk addressed in  ISO 9001:2015?

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Introduction - the concept of risk-based thinking is explained Clause 4 - organization is required to determine its QMS processes and address its risks and opportunities  Clause 5 – top management is required to Promote awareness of risk-based thinking Determine and address risks and opportunities that can affect product /service conformity Clause 6 - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them

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Clause 7 – organization is required to determine and provide necessary resources Clause 8 - organization is required to manage its operational processes Clause 9 - organization is required to monitor, measure, analyse and evaluate the effectiveness of actions taken to address risks and opportunities Clause 10 - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8)

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Successful organizations intuitively apply risk-based thinking because it brings benefits that: improve governance establish a proactive culture  of improvement assist with compliance  assure consistency of quality of products and services improve customer confidence and satisfaction

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Identify what your risks are – it depends on context Use risk-based thinking to prioritize the way you manage your processes ISO 9001:2015 does not require formal risk management ISO 31000:2009  Risk management — Principles and guidelines   may be a useful reference for organizations that want or need a more formal approach to risk (but its use is not obligatory)

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Balance risks and opportunities Analyse and prioritize your risks 	what is acceptable? 	what is unacceptable? Plan actions to address the risks 	how can I avoid,  eliminate or mitigate risks? Implement the plan;  take action Check the effectiveness of the action;   does it work? Learn from experience;   improve

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Risk-based thinking: is not new is something you probably do already is ongoing ensures greater knowledge of risks and improves preparedness increases the probability of reaching objectives reduces the probability of negative results makes prevention a habit

ISO 9001:2015 Risk-based thinking

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