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What are the important steps to start implementing Risk


management in the QMS?
It is important to accept that the main task of the initial
implementation of risk management in the QMS - making
actions to address risks and opportunities an integral part of
management decision-making at all levels.
Then the keyword is "simplicity".
Implementation of risk management into the QMS processes
(ISO 9001:2015 cl.4.4.1.f, cl.6.1 and step "Do" - ISO 31000)
consists of four phases:

risk identification,

risk analysis,

risk evaluation,

risk treatment.

1) Risk identification consists of finding, recognizing and describing the risk. The ultimate
objective of risk identification is to draft a comprehensive Risk list.
At this phase, the following is important:

A common approach to risk wording for all processes. A good practice is to word
the risks through the "Event" category - an adverse event that may occur with
some likelihood.

Adding all possible risks to the Risk list, including the risks with negligible
likelihood.

2) At the Risk analysis phase it is important to:

Use a simple method of risk level (R) determination, which is clear and can be easily
accessible to a broad range of employees. A good practice is to use a ratio:

R=CL
where
C consequences,
L likelihood.

Commonly use an expert evaluation in determining the components of level of


risk, as well as in determining risk criteria at the Risk evaluation phase. At the
same time, evaluate the consequences on the extent of the potential adverse
impact on the user (external or internal).

3) At the Risk evaluation phase (risk ranking, matching the level of risk and risk criteria
as well as the allocation of risk in relation to which it is necessary to carry out risk
treatment), the following is important:

ISO 9001:2015 Risk Based Thinking QnA

CBG Inc. 2016

Supporting the work of Quality


Professionals
www.c-bg.com

training@c-bg.com

The level of risk criteria (the maximum allowable level of risk, below which risk
treatment is required) should not be set very high. This allows to process the
greater amount of risk and avoid possible initial stage errors.

4) At the Risk treatment phase, which is conducted in order to prevent, or reduce,


undesired effects and to enhance desirable effects at the process level, it is important to:

Start with the application of quality management tools, which the team already
possess. In reality, the use of cause and effect diagrams in conjunction with
"brainstorming" can already give the desirable effect.

ISO 9001:2015 Risk Management resources:

Actions to Address Risks and Opportunities Quality system procedure

ISO 9001:2015 Actions to address risks and opportunities in QMS


processes Methodical Manual

Risk Management in QMS Processes

Free Downloads

Risk Management Requirements Implementation in ISO 9001:2015


clauses (Reference Table)

Risk Management Requirements in ISO 9001:2015 clauses (Presentation,


5 slides)

Risk Management in QMS Processes (Preview) (Presentation, 3 slides)

Related Products

ISO 9001:2015 Quality


Manual Template

ISO 9001:2015 Risk Based Thinking QnA

Control of Documented
Information in ISO
9001:2015 Clauses

ISO 9001:2015 Audit


Checklist

CBG Inc. 2016

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