How to meet 4-1 understanding the organisations context

What is 4-1 understanding the organisations context

Out of all the clauses in the ISO9001:2015 standard I think this is probably one of the easiest to implement. 4.1 asks that the organisation determines the external and internal issues that are relevant to the company and its strategic direction along with those issues that could impact on its ability to achieve the objectives of the quality management system.

4.1 Understanding the organization and its context

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.

How to meet 4-1 understanding the organisations context

For me the ideal way to achieve this clause is to use the SWOT tool. This enables a firm to identify its strengths, weaknesses, opportunities and threats. Its perhaps one of the best known tools available to a business owner to analyse their company and its really really simple to use. But the main reason I would suggest using it is that the strengths and weaknesses aspect makes you consider the internal aspects of the company while the threats and opportunities make you think about the external issues that are relevant to the company.


Notes for clause 4-1

Note 1 reminds you that issues can include positive and negative factors. To be honest I think this is pretty obvious. If you are considering your firms weakness and threats you are going to consider negative factors or conditions and if you are going through strengths and oppotirnies then you will consider positive factors so I don’t know why they have put this note in. Perhaps they were trying to lead you towards the SWOT analysis in a roundabout way.

Note 2 is really just a nudge in the right directon for when you are working the SWOT. It highlights the external issues that you should consider which include  legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Those practices with SWOT will already have an awanress of these for those that don’t it’s this provides some ideas to start the SWOT.

Note 3 is really the same of note 2 but goes through the internal issues to consider including values, culture, knowledge and performance of the organization.

Its worth noting that following clauses will make reference to the factors mentioned in notes 2 and 3 so a good SWOT done for clause 4-1 will save you time and effort when you come on to the later clauses.

Applying 4.1 understanding the organisations context

So you probably came here to learn about how to meet the requirements of the clause. To help with this I have included a few points that its worth considering when you do yours and some of the points I included when I did a SWOT for my firm.

If you’re not sure about how to do a SWOT then here 4-1 understanding the organisations context’s a quick video or if you prefer reading to go the marketing teachers site for a quick explanation of SWOT analysis.


  • Number of and modernity of machinery
  • Knowledge of staff and their experience
  • Brand strength and awareness
  • Geographic size and reach
  • Range of material stocked


  • Number of staff to cover busy periods in sales/production
  • Could relate to the condition of any old machinery
  • Succession planning could be important for firms with an old workforce
  • Financials – could related to cash flow or working capital


  • New products
  • New Markets
  • Possibility to acquire competitors or other firms
  • Changes in law that could be beneficial


  • Competitors
  • Potnetially could relate to suppliers

All of these aspect will impact the company and its ability to implement the quality manamgent system and ensure it is sucessfully sustained so when you are work through the swot make sure you keep your mind focussed on the impact of each item on the quality system as any auditors are going to want to see that you have related the swot to the requirements of the clause.

So hopefully this gives you some ideas for what you can do to meet the requirements of 4.3. As ive said its not really difficult, it can be time consuming however if done right it can highlight a number of things that can help to improve your business. Plus you will refer to this when looking at some of the other clauses so its worth spending your time doing it right.

Let me know what you have done in your firm when looking at 4.3. Have you used swot as well?

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