All you need to know…Context of the Organization – Clause 4 of ISO 9001:2015

big checklist

Now that you’ve started your transition journey, perhaps we can save you some time and still make sure you end up with a system that is an asset for your organization, not a liability. This series is more of a ‘how to…’ rather than just a description of the requirements. The requirements series starts here, in this blog post:

Clause 4 – Context

By taking the time to really get a handle on our ‘context’ we can build a better Management System, aimed at our ‘Interested Parties’ and adding value to our organization.

In our training classes, we always do an exercise where the participants identify 3 sets of information relevant to their organizations: Internal Issues, External Issues and Interested Parties. You can do the same as you begin your transition journey.

In ISO 9000:2015, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an organization’s  approach to its products, services  and investments and Interested Parties“.

We begin this part of the ‘how to…’ by taking a look at Internal Issues, External Issues and Interested Parties that could include:

Internal Issues

  • Organizational Structure: are we flexible? Can we go with our customers’ flow?
  • Are our employees eager to try new things or stuck in their ways?
  • What’s the state of our work force and can we find more competent people quickly?
  • How does our organizational culture(wages, working conditions, Leadership, communications, reputation) stack up against our competitors ?
  • Do we need to fire some of our customers?
  • Can we expand our customer base?
  • Are our investors happy?

External Issues

  • Are we impacted (negatively or positively) by changes in Legislation and/or Regulations?
  • How is the economy performing? Do we have access to good data on the economy?
  • Is ‘technology’ an important factor for us to consider?
  • What’s happening with our customers?
  • What are our competitors up to?
  • Are we keeping up with Standardization and Certification within our industry?

Interested Parties – External

  • Customers, of course!
  • Dependants of our employees
  • Governments – Federal, provincial, municipal
  • Associations relative to our organization – trade groups
  • Regulatory bodies
  • Insurers
  • Pressure groups
  • Competitors
  • Contractors and sub-contractors
  • Our Bank
  • Emergency services

Interested Parties – Internal

  • Employees
  • Business partners
  • Union representatives
  • Contractors and sub-contractors

This can get you started, and the information can be captured easily in a group session. Get as many points of view as you can to get a good variety of issues identified and a robust list of Interested Parties then use this information to build your next System.

ISO 9001:2015 does not make a specific requirement to maintain documented information about this, but it does require (4.1) that, “The organization shall monitor and review information about these external and internal issues.” and (4.2) “The organization shall monitor and review information about these interested parties and their relevant requirements.” 

So you’ll need to be able to demonstrate that you are monitoring and reviewing this information. A grid or spreadsheet might be a simple way to meet this requirement, or a line item on the Management Review Agenda (Clause 9.3). Keep it simple…

The final clause’s requirements can be met with a series of well-designed flowcharts and related explanations. Remember to give your employees credit for having a brain and don’t over document your processes. Focus on getting the right result, not just following the procedure to the letter. This can lead to fear of experimentation and ‘Improvement’ will be hard to find.

To find out if your ISO life can be simpler…

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  1. mohmed huussein on January 3, 2017 at 3:28 am

    Dear: sir
    please can you send example how i put or document context of organization in paper

    • Jim Moran on February 19, 2018 at 8:23 pm

      It’s fairly easy to do, Mohmed – just make 4 columns in a table in a word document, or in 4 columns in an excel spreadsheet.

      Mark the columns – ‘Internal conditions’ ‘External conditions’ ‘Interested Parties’ ‘Needs and expectations of Interested parties’
      Then use the notes at the end of 4.1 (notes 1, 2 and 3) for the Internal and External conditions (issues) and look at the Annex notes on ‘Interested Parties’. It will be unique for every organization. Search Google for examples, too.

      Good luck with it!