4.1 Understanding the Organisation and its Context

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Understanding the organisation and its context

This Step 1 in the ‘Plan’ stage of the ’PDCA’ cycle. Define, build, operate and improve your QMS. Your mangement system should define your organization’s goals and intended outcomes, determine internal and external issues, identify stakeholders and their requirements, and define the management system’s scope. The guidance shown on this page is relevant to the following standards:

ISO 9001:2015
ISO 14001:2015
OHSAS 18001:2007

Determining the context of your organisation is a requirement that is new to ISO 9001. Also known as contextual intelligence, this approach is not new to those familiar with business planning and strategic development, but it is new in terms of its specific inclusion to ISO 9001:2015 and ISO 14001:2015.

Your organization is now required to identify and asses all internal and external issues that could impact upon your quality or environmental management system’s ability to deliver its intended results. You should allow time to develop an understanding of the key internal and external factors that influence your business, and to set up processes to monitor and review these issues.

Internal issues

To help understand your business's internal issues, at the mirco level, you need to understand its strengths and weaknesses and be able to identify relevant opportunities and threats. Undertake a SWOT analysis to review and evaluate current business strategies, the position and direction of your organization, business propositions and other commercial leads.

External issues

External issues might include political, finanical or economic trends, customer demographics or emerging product developments. You should undertake a PESTLE analysis in order to establish a suitable understanding of these circumstances, and the market in which your business operates at the macro level. PESTLE analysis provides a framework for measuring market and growth potential according to external political, economic, social, technological, legal and environmental factors.

Demonstrating compliance

To be compliant, evidence should be reviewed that proves that your business has reviewed all pertinent internal and external issues at periodic intervals. Although there is no requirement for any documented information to defining organisational context, it is helpful to retain the following types of documented information to help justify compliance:

  1. Business plans and strategy reviews;
  2. Competitor analysis;
  3. Economic reports from business sectors or consultant’s reports;
  4. SWOT and PESTLE analysis;
  5. Minutes of management review meetings (showing descisions and actions relating organizational context);
  6. Process maps, tables, spreadsheets, mind mapping diagrams.


4.2 Interested Parties
4.3 Determining Scope
4.4 Management System Processes

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