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ISO 9001:2015
Overview
2015 Revision Issue
Revision each 5 until 8 years
2015
2008
1987
2000
1994
Establish a
systematic approach to
risk in the quality
management system.
Clause 7 on,
preventive actions
removed and replaced by
incorporating risk into
all standard.
Risk-based approach,
making the organization
proactively prevent or
reduce undesirable
effects and promote
continuous improvement.
What is
Risk-based thinking is
something that we've all done
automatically.
Example: If I want to
cross the road I will
ensure safe conditions
before my street. I
would not move if there
is a car in front of
moving.
What is
Example:
To cross the road I may directly or use the
pedestrian bridge nearby. I select a process that
will be determined by consideration of risk.
What is
Example:
Crossing the road in a
straightforward manner, will
provide an opportunity to
reach across the road
quickly, but the risk of
injury is high because there
is a car moving.
The risk of using the pedestrian bridge is that
I might be too late. But the chances of getting
hit by a car is very small..
What is
Example:
This situation shows that there are
opportunities to make further
improvements:
Prioritize direct subway under way
The traffic light pedestrian, or
Divert the road so that the area
to avoid traffic
Impact and feasibility should be considered in
decision making. Whatever action is taken will change
the context and risks.
Improving achievement
of defined objectives,
Intuitively successful
company always uses a riskbased approach
Clause 10 (Improvement)
organizations are required to
improve the response to changes
in risk.
How do I do it
Using the approach of risk factors
in the process of your organization
1. Identification
Identify the risks and opportunities of
each option will be taken
Example
Risk crossing the road at a busy time with a lot of
fast moving cars, not the same if the cross on a
deserted road with a bit of a moving car.
How do I do it
2. Create Priorities
How do I do it
3. Case Analysis.
How do I do it
4. Create a Plan
How do I do it
Sample Case:
I could eliminate the risk of
injury by using the bridge but
I've decided that any risks that
occur when crossing the road is
acceptable.
Plans and considerations:
Reduce the possibility of injury
and injury or effect, the cross
when no cars are moving at close
to me.
How do I do it
5. Implement the plan and
take action
Examples:
I cross the street, check
there are no barriers to
cross over and take a safe
place in the middle of moving
traffic.
How do I do it
6. Check the effectiveness
of the action and how it
works?
Examples:
I came across the street
unharmed and timely. This plan
is executed and undesirable
results can be avoided.
How do I do it
7. Learning from experience
and continuous improvement.
Example
I repeat the plan for a few days, at different times
and in different weather conditions.? Experience
teaches, that cross the road at a certain time of day
is very difficult because there are too many cars.
How do I do it
8. Some considerations
innovative opportunities:
Conclusion
Risk-based thinking is not a
new thing and something that you
have done and continuously
Risk-based thinking:
Ensure greater knowledge and readiness.
Increase the likelihood of achieving the goal.
Make a habit of prevention
Reduce the possibility of a bad outcome.
Source readings:
....
ISO 31000: 2009 Risk Management Principles and
guidelines
PD ISO / TR 31 004: 2013, Guidelines for the
implementation of risk management - ISO 31000