Criterios de interpretación de los requisitos de
ISO 9001:2015
--------------------------------------------------------------------------------------------------------------------------Senior management are the charged with cascading to lower levels of the management at
operational and work task levels. It is absolutely essential that the structure which
formalises responsibilities, authorities and communication route becomes part of
organizational culture.
Establishing a workable and effective management structure that assigns appropriate
responsibilities to designated personnel is a factor for successful. It is vital that everyone in
the organization knows what part they play in operation and supporting the system and
their responsibilities towards accomplishing the objectives and targets set.
Defining responsibilities and creating organization chart, these fundamentals are important:
-

the executives directors of the company must be associated with quality system
structure so that support and commitment are seen from the top.

-

Personnel involved with the quality management should be included in the quality
management document.

6. Planning
6.1 Actions to address risks and opportunities
6.1.1 and 6.1.2 This chapter is a brand new requirement of ISO 9001, but risk based thinking
is not. There is not any formal method for the risk managing, neither documented process,
but ISO 31000 (“Risk management — Principles and guidelines”) will be a useful reference
Not all processes of a quality management have the same risk level in term of ability of the
organization to achieve goals. The company is responsible of application of risk based
thinking and taking right decisions to address risks.
Once identified risks and opportunities, following actions could be taken to address them:
a) Avoiding the risk: quit the process which is originating the risk. The output of this
decision could be not acceptable.
b) Assume the risk: some risk could be considered a positive risk, in those cases; a risk
could become opportunity.
c) Eliminate the risk source: one example of this kind of mistakes is used to be
provoked by human, in construction is not easy to eliminate that risk, because of
difficulties of automatization.
d) Reduce the probability of occurrence or its impacts.
e) Share the risk with other stakeholders.
f) Keep the risk. When the risk is too expensive to take off and the output does not
improve as much as reaching financial equation.

It is strong recommended developing a contingency plans if the risk could not be
eliminated or avoided at all.

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