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By: Peter Sheren

The 2015 Version of the ISO9001 Quality Management System standard has introduced the concept of Context of the Organization.

In clause 4.1 the standard states:

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.

The use of the word “shall” in the standard basically means you must do what is stated, period. And it puts the proof of compliance squarely on the registered organization. Using SWOT terminology to define the Context is a very acceptable and understandable method. Let’s look at a straightforward way to document this requirement.

Set up a Document with a table containing the following headings:

Context IssueInternal or ExternalStrength/OpportunityWeakness/ThreatReview Method And Frequency

Once the table is populated with Context issues or elements, identify each as Internal or External and what the detail of the SWOT element is along with how the organization evaluates each. Populate the table with a brainstorming session with senior and functional management participation and you have a working document that can be used in Management Review meetings and maintained for guidance throughout the organization.

At Storti, we believe that if we are not offering you value than we aren’t doing our job. By implementing a high quality QMS system we can significantly lower your risk and save you money at the same time. To learn more about our services and how we can help please contact us at info@stortiservices.com or 844-478-6784.