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Its a new
requirement which has been identified in the latest version of the standard. Lets first
understand the definition of the term Context of the organization which is
mentioned in ISO 9000:2015 where the definition of the same as given:
Definition:
Combination of internal and external issues that can have an effect on an
organizations approach to developing and achieving its objectives
It says before developing the QMS standard, first understand the organization. What
the strengths of the organization, what the weakness of the organization, internal as
well as external. Context of the organization may also be called as business
environment. The organization must consider both the internal and external issues
that can impact its strategic objectives and the planning of the QMS. Internal and
external factors keep on changing. The internal and external issues could be positive
or this could be negative.
Context of the organization requires the organization to evaluate itself and its
context. This means that you need to define influences of various elements on the
organization and how they reflect on the QMS, the companys culture, objectives
and goals, complexity of products, flow of processes and information, size of the
organization, markets, customers, etc. It is also a means to detect risks and
opportunities regarding the business context.