Understanding ISO 9001:2015 - Clause 4.1

​3 Easy Ways to Determine the Context of Your Organization​

In this week's blog, we will dissect and better understand Clause 4.1.1. Of the ISO:9001 standard. This clause essentially changes the application and concept of clause 4. Context of the organization is a brand new requirement in this revision of ISO 9001, and your organization must now take into consideration both internal and external issues that can have an effect on strategic objectives and the planning of QMS.  We now need to determine the context of our processes and procedures to comply with this clause.

So how do we do that? I'm so glad you asked…

1. Evaluate Your Organization. The first step is to look into your organization and evaluate processes, procedures, and context. Take time to evaluate all of the elements of your organization and their influences. Look at how they reflect on the management system. Take a look at your company's culture, flow of information and processes, company size, objectives, goals, complexity or simplicity of products, customers you serve, markets, the list can go on and on. You also will want to remember not to overlook the possible risks as well as possible opportunities regarding your company's business context.

 2. Determine The Requirements. After you evaluate all aspects of your company, the next step is to determine which new requirements your company has already met in your existing documentation, and which are not yet met.  If your company has already been using ISO 9001:2008, then you've already defined the scope of the management system and sequence of processes and interactions in your Quality Manual.  Using these as an input to determine your context can save you time and prevents you from having to start from scratch!  If you do have to start fresh and determine the scope of your management system, no big deal - the bulk of this task was done in Step 1 with your evaluation.  Don't forget to determine and include your relevant interested parties. See last week's blog on for more information on relevant interested parties!

 3. Document, Document, Document. After you've evaluated and determined your requirements, it's important to put pen to paper (or keyboard to monitor) and document your context.  It is very helpful to document this context as a part of your scope within your Quality Manual.  The standard does not specifically state that the context needs to be maintained as documented information, but it certainly helps with setting the strategic direction of the organization if the context is spelled out in black and white.  
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If you take a step back, your context already exists, this process just helps you understand and firm it up.  Think of it this way - if someone asked you what your company does and who it serves - what would you tell them?  Think of what your response would be.  That alone will give you a great jump-start to understanding your context.

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