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Understanding ISO 9001:2015

Clause 4.1 Understanding the organization and its context 

In 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.  

A good way to understand this requirement is to look at it graphically: 


Contextual Factors


Nature of exposure

To your organization


Impact on your organization’s


External Factors

Internal Factors

Relevant Interested Parties



Risk  or Opportunity


Purpose & Strategic Direction

QMS Objectives

QMS Products & Services

QMS Scope

QMS Processes

QMS Resources

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 organization.

Organizations face 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 to:

·   Its purpose and strategic direction; 

·   The ability of its QMS to achieve its intended results which is to consistently meet customer and regulatory requirements and enhance customer satisfaction.  

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 following actions:

  1. to identify each specific organizational contextual issue that may impact the organization and its QMS;  acquire and evaluate timely knowledge and information about them; 
  2. evaluate the risks and opportunities that these contextual factors present and 
  3. take appropriate actions to mitigate the risk or exploit the opportunity under clause 6.1; 
  4. 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.


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Understanding ISO 9001:2008