Definition of Context

Context of the organization means the business or organizational environment of the organization. As you can see from the figure from ISO 9001standard below, Context is shown to be outside the processes and functions of the organization and is seen as affecting the organization.

To put it simply Context means the issues affecting the organization. Issues can be both positive and negative, meaning that their effect on the organization can result in a loss or a profit.

Context can be both External and Internal. External Context can be the issues arising from technological, competitive, market, cultural, social and economic environment which can be international, national or at a local level.

Internal Issues can relate to values, culture, knowledge and performance of the organization.

ISO 9001

Finding the Issues

It is the responsibility of the organization to find out the External and Internal issues that are relevant to its objective and purpose and the strategic direction in which the organization is moving. The organization has to find out how are the issues or factors going to affect the strategy that it has chosen to succeed. The strategy can be for example Marketing strategy or the Advertising strategy.  If the organization is using a technology for production, then it has to evaluate the changes in the technology and how the competitors are reacting to it. If the organization is using state of the art latest strategy then it can use that factor in its marketing and advertising to inform the customers that it is ahead of its competitors and is providing a better product.

The organization has also to look at how these issues affect the outputs of its Quality Management System. This can be the effect on the products and services provided by the organization. Or the effect on the processes established by the organization to achieve its objectives.

An organization’s context may include:

  • Specific objectives and targets of the organization;
  • Products and services it provides;
  • Complexity of the organizational processes and their interaction;
  • Competency of employees within or behalf of the organization;
  • The size and structure of the organization.

An ISO 9001 Consultant can rightly guide you to find out the issues affecting the Context of your organization. If you are going for ISO 9001 Certification, then this new requirement in the 2015 version has to be met.

Monitoring the issues

After finding out the issues, the organization has to consistently and periodically monitor the issues and review the information related to them. This can be done by the top management in the Management Review Meeting. The inputs of the Management Review shall include the issues from the context of the organization.How is the internal and external environment changing and how it will affect the organization in the future? Then the top management can develop a strategy to minimize the expected losses from an emerging issue or maximize the gains from a positive factor.

External Issues

The organization can do the PESTLE Analysis or look into the Political, Economic, Social, Technological, Legal and Environmental factors affecting the organization. If the organization has entered a new market in another country it has also got to look into the cultural factors of that country. It can look at the strategies being pursued by its competitors. It can look into the market conditions and the practices which are a norm in that market.

Internal Issues

Internal issues that require to be identified are the organizational culture and practice and how it is affecting the work environment. The organization has to look into the values being promoted by it and how they contribute to achieving its objectives. The organizational knowledge which is derived from experience and handed down from one generation of owners and employees to the next generation has to be preserved and utilized to get the best practices for doing work. The performance metrics of the organization from different processes such as Production, Quality Control or Customer Satisfaction etc. has to be monitored and used to make a strategy for better outputs in the future.

Auditors can also get information about the context from interview with top management and looking at the business plan or strategy, the company’s website, minutes of the management review meetings, the company’s Annual Reports.

The organization can also use the Process Approach to identify the relevant internal and external issues by finding out the sources of Input to the Process to the Output Receivers.

Interested Party

An interested party is any person or organization which can affect or be affected by or perceive themselves to be affected by the decisions of the organization implementing the Quality Management System. To find out an interested party the organization has to look into whether or not it has an effect on the organizations ability to consistently provide products and services.

Interested parties can be the organization’s employees, shareholders, end users, suppliers, customers and regulators etc. The requirements of interested parties can be employee feedback forms, Specifications from raw material Manufacturers or Suppliers, Contractual requirements from Customers, Legal requirements or Corporate Policies and Procedures etc.

The organization has to find out the interested parties and then monitor their requirements and the information about them.


So to get ISO 9001 Certification, you may need the services of a qualified ISO 9001 Consultant who can guide you through the multifarious requirements of the new 2015 version and help you identify the Context of the organization correctly as it has an immense effect on the organization’s strategy for survival and growth.

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