ISO 9001 2015.pdf


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Criterios de interpretación de los requisitos de
ISO 9001:2015
--------------------------------------------------------------------------------------------------------------------------- Improvement: Successful organizations have an ongoing focus on improvement.
Improvement is essential for an organization to maintain current levels of
performance, to react to changes in its internal and external conditions and to
create new opportunities.
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Evidence based decisions: Decisions based on the analysis and evaluation of data
and information are more likely to produce desired results.
Decision making can be a complex process, and it always involves some uncertainty.
It often involves multiple types and sources of inputs, as well as their interpretation,
which can be subjective. It is important to understand cause-and-effect relationships
and potential unintended consequences. Facts, evidence and data analysis lead to
greater objectivity and confidence in decision making.

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Relationship management: For sustained success, an organization manages its
relationships with interested parties, such as suppliers.
Interested parties influence the performance of an organization. Sustained success is
more likely to be achieved when the organization manages relationships with all of
its interested parties to optimize their impact on its performance. Relationship
management with its supplier and partner networks is of particular importance.

0.3 Process approach
0.3.1 General
This is the most essential principle of the International Standard. It pretends its application
to overall quality system. It applies to the processes as well as to support, monitoring and
measurement.
General requirement of process management is collected in chapter 4.4 Quality
management and its processes of this International Standard. There are two concept which
are intrinsically linked to the process approach:
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Deming circle: known also as PDCA (planning – do – check – act). It consists to bring
out the following phases to the process:
Planning: determinate which is the intended result of the process, then
according to results stablishing operational activities, resources and
responsibilities to achieve it.
Do: carry out what have been planned in a scheduled time.
Check: monitoring and measuring the outcomes achieved, then evaluate is
appropriate to the target stablished in planning.
Act: take suitable actions to correct any deviation found, or to improve
intended results.

Deming circle not only applies to the individual processes, it also applies to the global
management system.

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