Criterios de interpretación de los requisitos de
ISO 9001:2015
--------------------------------------------------------------------------------------------------------------------------“This International Standardprovides provides the fundamental concepts, principles and
vocabulary for quality management systems (QMS) and provides the foundation for other
QMS standards. This International Standard is intended to help the user to understand the
fundamental concepts, principles and vocabulary of quality management, in order to be able
to effectively and efficiently implement a QMS and realize value from other QMS standards.”
4. Context of the organization
4.1 Understanding the organization and its context.
The chapter 4.1 is a brand new requirement on this international standard. This requirement
forces the organization to analyse the context where they working in. The external context
includes: competitors, new technologies, legal requirements, cultural etc. as examples very
clear of extern context. The interns’ issues could be: company’s history, works methods,
labour regimen, etc. This analysis will help the organization to take the strategical decision.
SWOT analysis is strongly recommended as a tool to analyse and understanding the context
of the organization. The acronym SWOT means Strength, Weakness, Opportunity and
Threats. The main purpose of this analysis is figure out the organization SWOT. Once defined
the object to analyse, what pretend to get with this is method which point could impact the
performance negatively and positively.
1. Internal issues: it could be the financial resource, experience in the area,
organization structure, internal communication, customer approach, high-tech, etc.
It got categorized in:
a) Weakness: aspects which impact negatively to the performance
b) Strength: aspects which help to goal the target.
2. External issues: it could refer competitors’ actions such as lower prices, marketing;
laws changes; new technologies, social values, etc. It got categorized in:
a) Opportunities: conditions that could favour more than the expectation.
b) Threats: external situation which could harm the business, it’s a risk for the
organization, which prevents the organization to achieve the set goals.
A very simple example applied to a construction company:

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