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Reviewing ISO 9001:2015 Clause 4.1 Requirements

Jackie Stapleton
Posted by Jackie Stapleton on 9 November 2021 12:04:31 PM

It is time to look at what ISO 9001:2015 Clause 4.1 requirements look like when implemented into a business.


What are ISO 9001:2015 Clause 4.1 Requirements?

In this article, we have a video where Jackie explains the requirements of Clause 4.1 and turns it into something we can all understand. You will be then able to apply this to your own organization's system and understand what the requirements will look like for your business.

No more guessing or confusion! 

Clause 4.1 Understanding the organization and its context states that 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 results of its quality management system. I always say with this clause that ‘it’s about having a long hard look at yourself’!

The requirements of this clause are about the organization identifying internal and external factors that influence their product or the delivery of their product or service to its customers. You could say that this is standard business planning and management of course. So, the question for us is ‘what does this look like in a business?

A tool or tools that I normally see being used to address this clause requirement are the PEST Analysis along with or even just standalone - a SWOT Analysis. 

What is a PEST Analysis?

The PEST Analysis, sometimes referred to as PESTEL or PESTLE is a great tool to identify External issues and it works well when combined with a SWOT Analysis. PESTEL stands for Political, Economic, Social, Technological, Environment and Legal. You can see by using these words as a prompt it forces a business to look at what influences these categories bring to their business.


What is a SWOT Analysis?

A SWOT is normally drawn up into 4 quadrants, with each quadrant named one of the options of Strengths, Weaknesses, Opportunities and Threats. This is a fantastic tool to use as it aligns really well with the internal and external requirements of clause 4.1. So now you can add to the rows the heading of Internal for Strengths and Weaknesses and External for Opportunities and Threats. I always say that Strengths and Weaknesses are Internal and what is actually happening now. And then Opportunities and Threats come from external influences and are what has the potential to occur.

If you want to get some quality into your business enrol in one of our quality courses now.

Looking for more than just training, why not work with Jackie to get your quality system the best it can be. Book in for a FREE 15 Discovery Interview here.

Topics: ISO 9001 Quality, Video

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