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Clause 4.0 in ISO 9001:2015 is termed as Context of the organization.

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:
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.

What are internal and external issues?

This requirement of clause 4 can seem too general, and there is a risk of going too
wide when defining the internal and external issues. In fulfilling this clause, focus
to be only on issues that can affect the customer satisfaction and delivery of quality
product and/or service.
Internal context can include its approach to governance, its contractual relationships
with customers, and its interested parties. Things that need to be considered are
related to the culture, beliefs, values, or principles inside the organization, as well as
complexity of processes and organizational structure.
Some examples of internal factors could be
a) Culture of the organization (culture, beliefs, values, or principles inside the
b) Knowledge base of the organization,
c) Past performance of the organization
d) Organizational structure
e) Approach to governance
f) Its contractual relationships with customers, and its interested parties
g) Complexity of processes
To determine external context, you should consider issues arising from its social,
technological, environmental, ethical, political, legal, and economic environment.
Examples of external context may include:
a) Legal issues (government regulations and changes in the law)
b) Change in technology
c) Culture outside the company
d) Economic shifts in the organizations market)
e) Competitive environment (the organizations competition)
f) Events that may affect corporate image
g) National / internal / global issues.
Basically, all this information is in the heads of the CEO and other members of
management, but it was never put on paper; the best way to gather it is by organizing
some brainstorming. Systematization of all this information can be very valuable
and demonstrate where you stand as an organization.
Should we ask others?
Interested parties include direct customers, end users, suppliers and partners,
regulators, and others. Others could include people in the organization,
owners/shareholders, and even society. These parties add value to the organization
or are impacted by the activities within the organization. Identifying and meeting
their needs is important to implementing an efficient and effective quality
management system. Their feedback can really help you to determine what can be
improved in your organization, and how.
Shall we put it in paper?
As per the standard is concerned, it doesnt specifically tell us to have documented
information on the context of the organization. However it is equally good for an
organization to have the same. May be not necessary, to be shown to everybody
however, key person in organization should have an access to use and most
importantly, monitor and review the same.
Where to start?
The following 4 steps is a quick snapshots that can be applied.

Last, but not least

Regular management review is necessary to monitor the organizations internal or
external issues. Once the internal context is understood, management can conduct
an external analysis using PEST (political, economic, social, technological) and
SWOT (strengths, weaknesses, opportunities, threats) analyses and really benefit
from this new requirement, instead of just formally fulfilling it.
The context of the organization seems like one of the document and forget about
it requirements, but it shouldnt be. Information gathered through defining context
can be very useful for identifying room for improvement, and it shouldnt be taken
for granted. Knowing the context of your organization and opinions of your
interested parties can help you improve your organization and make it even better