IS0 9001:2015

Clause 4.1 Understanding the organisation and its context

This is the first of two new clauses introduced in the 2015 release relating to Context.

Note: When building or updating a Management System, I always recommend that the next clause (4.2 Interested Parties) be addressed first, as it naturally inputs into this one!

In order for an organisation to have an effective management system (and therefore, succeed as a business), the management system should be aligned with the businesses strategic aims and take into account the relevant internal and external issues when planning to achieve its objectives. Both positive and negative factors should be considered. IE:

Organisations are required to determine external and internal issues that are relevant to their purpose and their strategic direction and which can affect the organisations ability to achieve the intended results. So, we are talking about the Operating Environments of the organisation. IE. Both external and internal influences…

Understanding the external context can be facilitated by considering for example:

The needs and expectations of stakeholders including customers (stakeholders are now termed interested parties – see article 4.2,) Legal, technological, competitive, market related and cultural, social, and economic environments, whether international, national, regional or local.

Understanding the internal context could consider issues related to:

Organisational process interactions / business structure and their complexity, types of products and services provided, values, culture, knowledge, objectives and performance of the organisation.


Most effective organisations will already be successfully monitoring and responding to external and internal, positive and negative issues that have the potential to affect the management system and hence the overall success of the business.

Audit Check:

There is no requirement for documented information to demonstrate compliance with clause 4.1 in the standard, but it probably already exists and therefore can be used to support statements made to an auditor. For example:

Competition / SWOT analysis, strategic / business plan / reports to shareholders, business sector economic surveys and reports, employee engagement surveys. Minutes of Management review meetings and action plans.

(Alternatively, a simple “internal / external” context matrix can be built from a cross functional brainstorming session. I can provide a proven template if you wished to go this route, which will certainly make it easier to please an external auditor. However, do be sure that such a document will add value to your business before embarking and make sure that if such a document is created that it is regularly reviewed and updated. Management Review might be a good time to do this.)

However you decide to address this clause, due to its high level strategic nature, senior management should expect to be asked to demonstrate compliance during an audit.

This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!

David Barker CQP MCQI

ISO 9001:2015

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