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Understanding Risk-Based Thinking in ISO 9001

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, from the beginning and throughout the management system. It is addressed throughout ISO 9001:2015, including in determining processes, identifying risks that can affect products/services, and taking actions to improve the management system. Using risk-based thinking can improve governance, establish a proactive culture, and help assure quality and customer satisfaction.

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100 views11 pages

Understanding Risk-Based Thinking in ISO 9001

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, from the beginning and throughout the management system. It is addressed throughout ISO 9001:2015, including in determining processes, identifying risks that can affect products/services, and taking actions to improve the management system. Using risk-based thinking can improve governance, establish a proactive culture, and help assure quality and customer satisfaction.

Uploaded by

Ali
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

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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