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Risk-Based Thinking: ISO/TC 176/SC 2/N1283

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This presentation from ISO/TC 176/SC 2 explains the concept of risk-based thinking in ISO 9001:2015. Risk-based thinking involves identifying risks and determining actions to address them throughout strategic and operational planning. It is addressed throughout ISO 9001:2015, from determining quality management system processes to evaluating effectiveness and improving the system. Using risk-based thinking helps organizations improve governance, establish a proactive culture, assure quality, and improve customer satisfaction.

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Risk-Based Thinking: ISO/TC 176/SC 2/N1283

Uploaded by

Ali
43 views11 pages
This presentation from ISO/TC 176/SC 2 explains the concept of risk-based thinking in ISO 9001:2015. Risk-based thinking involves identifying risks and determining actions to address them throughout strategic and operational planning. It is addressed throughout ISO 9001:2015, from determining quality management system processes to evaluating effectiveness and improving the system. Using risk-based thinking helps organizations improve governance, establish a proactive culture, assure quality, and improve customer satisfaction.

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This presentation from ISO/TC 176/SC 2 explains the concept of risk-based thinking in ISO 9001:2015. Risk-based thinking involves identifying risks and determining actions to address them throughout strategic and operational planning. It is addressed throughout ISO 9001:2015, from determining quality management system processes to evaluating effectiveness and improving the system. Using risk-based thinking helps organizations improve governance, establish a proactive culture, assure quality, and improve customer satisfaction.

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Download as PPTX, PDF, TXT or read online from Scribd
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43 views11 pages

Risk-Based Thinking: ISO/TC 176/SC 2/N1283

Uploaded by

Ali
This presentation from ISO/TC 176/SC 2 explains the concept of risk-based thinking in ISO 9001:2015. Risk-based thinking involves identifying risks and determining actions to address them throughout strategic and operational planning. It is addressed throughout ISO 9001:2015, from determining quality management system processes to evaluating effectiveness and improving the system. Using risk-based thinking helps organizations improve governance, establish a proactive culture, assure quality, and improve customer satisfaction.

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You are on page 1/ 11

ISO 9001:2015

Risk-based thinking

ISO/TC 176/SC 2/N1283


1
Purpose of this presentation

To explain the concept of risk-based thinking in


ISO 9001:2015
ISO/TC 176/SC 2/N1283

2
This presentation

 Developed by the ISO subcommittee responsible


for ISO 9001

 Available for unrestricted public use


ISO/TC 176/SC 2/N1283

3
What is risk-based thinking?
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
ISO/TC 176/SC 2/N1283

Risk-based thinking ensures risk is considered


from the beginning and throughout
Risk-based thinking makes preventive action
part of strategic and operational planning
4
Where is risk addressed in

ISO 9001:2015?
ISO/TC 176/SC 2/N1283

5
Risk-based thinking is in:
 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
ISO/TC 176/SC 2/N1283

 Clause 6 - organization is required to identify risks and


opportunities related to QMS performance and take
appropriate actions to address them

6
Risk-based thinking is in:
 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
ISO/TC 176/SC 2/N1283

 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)
7
Why use risk-based thinking?
Successful organizations intuitively apply risk-
based thinking because it brings benefits that:
 improve governance
 establish a proactive culture of improvement
 assist with compliance
ISO/TC 176/SC 2/N1283

 assure consistency of quality of products and


services
 improve customer confidence and satisfaction

8
How do I do it?
 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/TC 176/SC 2/N1283

 ISO 31000 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)
9
How do I do it?
 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?
ISO/TC 176/SC 2/N1283

 Implement the plan; take action


 Check the effectiveness of the action; does it
work?
 Learn from experience; improve
10
Conclusions
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
ISO/TC 176/SC 2/N1283

 reduces the probability of negative results


 makes prevention a habit

11

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