ISO 9001:2015 Insight: Clause 4.1 Understanding the Organization and its Context

by Breda Kearney | March 15, 2019 | Blog , Context of the Organization , ISO 9001:2015 , Quality , Top Management , |

To be successful and to achieve its strategic goals, an organization must understand the business environment in which it operates. The business environment is referred to as the “Context of the Organization” and it is influenced by internal and external issues. It’s important to note that these issues can either help or hinder the organizations ability to achieve its strategic goals and they can change rapidly. Therefore, to remain competitive, internal and external issues that are relevant to the achievement of the organizations purpose and strategic goals must be captured and continually monitored so that the organization can quickly adapt to any changes.

For example, with the greater social awareness of the environmental damage that is being caused by single-use plastics, organizations are being forced to rethink product and packaging design or risk customers leaving in favour of more environmentally friendly competitors.

How does the organization identify internal and external issues?

Internal issues relate to the organizations internal environment and its analysis may reveal some uncomfortable answers. But its important that the organization completes a true and honest appraisal of itself.  Useful questions to ask when identifying internal issues can include:

  • What are we especially good at?
  • What areas do we need improvement on?
  • What is the quality culture and level of engagement with the QMS?
  • What do our customer like the most and the least about us?
  • What is our competitive advantage?
  • What weaknesses do we have that could be exploited?
  • What are our biggest customer complaints?
  • What is employee morale like?
  • What is our employee retention rate?

External issues relate to the organization’s external environment. Useful questions to ask when identifying internal issues can include:

  • What weaknesses do our competitors have?
  • What are the unmet needs in the market that we could take advantage of?
  • What weaknesses do we have that our competitors can exploit?
  • What new products or services do our customers want?
  • Are there any changes in legal or regulatory requirements that could impact us?
  • Are there any political issues that may impact on us – for example Brexit?
  • Are there any issues that could result in increasing costs?
  • What are the key market drivers and trends?
  • What are the social and demographic trends?

When capturing internal and external issues, its important that the Top Management team involve individuals with a unique perspective who can provide a fresh and unbiased viewpoint. Often, new employees can provide a valuable insight into the organization’s operations.

How does the organization capture internal and external issues?

ISO 9001:2015 doesn’t mandate how the organization captures or documents its internal and external issues, but common business tools that are used include:

SWOT – Strength, Weakness, Opportunity, Threat

 SWOT – Strength, Weakness, Opportunity, Threat

How does the organization deal with its internal and external issues?

  • Issues that may impact negatively on the organizations ability to achieve its strategic goals need to be risk assessed and appropriate actions taken to mitigate any negative consequences.
  • Issues that may have a positive impact should be explored to identify the opportunities which would provide the greatest benefit to the organization
  • The organization must continually monitor and review its internal and external issues. ISO 9001:2015 requires that a formal review is conducted as part of the management review, but more frequent reviews may be required dependent on the particular organization.

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