Clause 4.1 Understanding the
organization and its context
clause 0.1 Introduction and 1.0 Scope we talked about how this ISO standard provides a generic set of control
requirements for all organizations and how these generic requirements must be tailored to fit the nature of
each business and their products and services. A big factor in such tailoring is to understand and consider
the business context of each organization.
way to understand this requirement is to look at it graphically:
Nature of exposure
To your organization
Impact on your organization’s
Relevant Interested Parties
Purpose & Strategic
There may be hundreds of
contextual factors that can potentially affect an organization. But we must only consider and evaluate those that
are applicable or relevant to your organization.
We need to examine the
details of each relevant contextual factor in the left hand column in terms of whether they present a risk or
opportunity to your organization in terms of the items listed in the right hand column.
In this clause 4.1 and
the next 4.2 we will discuss these contextual factors and provide examples of how to analyze their impact on your
strategic challenges that can affect their ability to grow and achieve long-term success. Operating in today’s
highly competitive business environment can mean struggling for markets, resources, or even survival.
To meet these
challenges, your organization must determine, understand and address the contextual issues that are relevant
· Its purpose and strategic
· The ability of its QMS to
achieve its intended results which is to consistently meet customer and regulatory requirements and enhance
Context relates to the
background, environment, framework, events, settings, or situations surrounding an organizations business
activities and interactions. It is the combination of relevant internal and external factors that affects its
ability and approach to providing products and services to its customer.
This means that you need
to understand how these contextual factors affect your organizations QMS, culture, objectives and goals, complexity
of products, flow of processes and information, size of the organization, markets, customers, etc, and to recognize
the risks and opportunities they present.
Clause 4.1 requires you to take the
identify each specific organizational contextual issue that may impact the organization and its
QMS; acquire and evaluate timely knowledge
and information about them;
- evaluate the risks and opportunities
that these contextual factors present and
- take appropriate actions to mitigate the
risk or exploit the opportunity under clause 6.1;
- and include all of this in documenting
the scope of the organization’s QMS, processes, products and services.
This article is an extract from my eCourse "Understanding ISO 9001:2015".
This eCourse shows you how to easily and effectively
IMPLEMENT all the requirements of this Standard.
askartsolutions 2015 Toronto