The document discusses the new requirements in ISO 9001:2015 for organizations to consider the internal and external context that can impact objectives and quality management systems. It provides guidance on evaluating internal factors like culture, objectives, and processes as well as external factors like regulations, market conditions, and competition. The key steps are to define the quality management system scope, identify processes and interactions, conduct a SWOT analysis, determine interested parties, and document it all in a new Context of the Organization document. Understanding the organization's full context through tools like a COTO Log, FMEA, and PEST analysis can help identify risks, opportunities, and improvements.

1. Identifying the Context of
the Organization
ISO 9001:2015

2. Context of the organization
– Context of the organization is a new requirement in ISO 9001, stating an
organization must consider both the internal and external issues that can impact its
strategic objectives and the planning of the QMS. t pretty much changes the
concept and application of clause 4, and requirements regarding the context of the
organization do sound a little bit vague, so what does this clause actually require?
– Clause 4 of ISO 9001:2015 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
company’s 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.

3. Where to start?

4. Context of the
organization
– Although the standard doesn’t prescribe the method for
determining the context of the organization, there are
some logical steps and milestones.
 If you are implementing the standard from scratch, then you
need to determine the scope of your QMS and identify the
processes and their interactions.

5. Defining The
Scope of the QMS
– Once the scope of the
QMS is defined, together
with exclusions, and
processes and their relations
are identified, the following
steps need to be taken

6. What are
internal and
external
issues?

7. Internal Context
– An organization’s internal context is the
environment in which it aims to achieve its
objectives. 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.

8. External
Context
– 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:
– government regulations and changes in the law
– economic shifts in the organization’s market
– the organization’s competition
– events that may affect corporate image
– changes in technology
– 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.

9. – 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, you should focus
only on issues that can affect
customer satisfaction and delivery of
quality product and/or service.

10. S.W.O.T. ANALYSIS- Good 1st Step

11. Interested
Parties

12. Should we care about other
people’s opinions?
In simple terms, the requirement for identifying relevant interested
parties means that you need to decide whose opinion about your
company you should care about.
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.

13. Let’s put it on paper
– Once all this information is gathered, it should be documented;
the standard is pretty explicit about it. But where it should be
documented? The first choice is to create a new document, and
this document will be something that the certification body will
require instead of a Quality Manual prior to the audit.

14. Putting it all together
Once the SWOT Analysis is completed and the interested parties are determined, you can begin to construct your organizations
full context along with its risks and opportunities as seen by your interested parties and your identified processes.
Some Great tools that can help build a strong road map that will help bring out the full extent of the context include:
COTO Log (Context of the Organization)
FMEA-Failures Modes Effects Analysis
“PEST” (political, economic, social, technological) ”

15. COTO Log Defines all of the Requirements of Context
Interested Parties
Issues and
Requirements
Risks Opportunities

16. FMEA Defines the Risks

17. PEST

18. The context of the organization seems
like one of the “document and forget
about it” requirements, but it
shouldn’t be. Information gathered
through defining context can be very
useful for identifying room for
improvement, and it shouldn’t 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.