ISO 9001 4.1 Breakdown
Let’s discuss the convoluted wording of clause 4.1 of the ISO 9001 Standards. I always struggle to find a way to explain to my clients what this section means. Leading with the phrase ‘let’s understand the organisation's context always leaves a blank look on people’s faces. This phrase doesn't mean much, no matter how educated or intelligent they are. So what does it look like, and why is it important?
Well, it is more simply asking, what are the influences of your business? These influences might be made up of some of the weaknesses in your business, the strengths, economic, financial, geographical, social, legal, political, institutional, technological, competitive situation and markets influences. Understanding this will help develop the scope of your management system.
You can understand these better by using SWOT analysis, PESTEL, business plan, or strategic risk assessment tools.
Auditor Training Online does a great job of breaking this down further.