4.1 Understanding the organization and its context (ISO 9001:2015)

Some new terminologies and concepts have been introduced with the update to ISO 9001:2015, the world’s favourite quality management system standard.  Some are new, some build upon concepts from earlier versions adding focus and clarity. UKAS recognises that there are a number of these which clients may need extra support to understand.  This series of blog posts intend to help.

Section 4: Context of the Organisation is one of these new terms.  It builds heavily upon familiar requirements from earlier versions whilst adding opportunities for the types of organisational understanding that drives business improvement.  Its first clause, 4.1 Understanding the organisation and its context, is one of several logical starting points for developing a new management system or reviewing an existing system in preparation for transition to the latest standard.

4.1.  Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.

It’s a concisely phrased requirement but it encompasses your entire organisation, its business environment, client/competitor landscape etc. at a local, national and international level as appropriate to your business. There are well established business analysis tools that can help with this.  None are compulsory, but many are useful. Fully addressing this requirement of the standard will provide you with a better understanding of your business and a firm foundation and direction for your quality management system.

Understanding the context of your organisation is the first step towards continuous improvement.


If you would like to know more or have any questions, please drop an email to Alastair on enquiry@-l-p.co.uk and he will be happy to discuss this with you.