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As we have mentioned before ISO 9001:2015 is very much focused on understanding the Risks in your Quality Management System and to your organisation and obviously how you will handle them. Clause 6.1 - Actions to address risk and opportunities is really focused on helping you do this, it's also got that keyword "SHALL" in the clause which means you must do it to meet the standard.
Clause 6.1 of the ISO 9001:2015 standard is a change to the previous standard and it is actually quite a useful change to be fair, it's all about getting you thinking about how you handle the risks that you have previously identified. Now if you have just jumped in here and you haven't been following along then you will want to go back and read the 2 clauses that Clause 6.1 references these are:
Clause 4.1 - Understanding the organisation & it's context (Context of the Organisation)
Clause 4.2 - Understanding the needs & expectations of Interested Parties
From these you will hopefully have done yoru SWOT analysis or perhaps you did push the boat out and the the full on PESTLE Analysis, irrespective you now have a list of risks that you are aware of in the business that could have an impact on yoru Quality management System and now ISO 9001 wants you to take some actions on them. The easiest way of doing this is to take each of the sections in order (Strengths, Weaknesses, Opportunities & Threats) and review each of the elements. Remember that just because soemthing is a threat to you today it doens't mean you can't turn it to an opportunity and vice versa so do all of them and not just what you percieve as a threat. Have someone play devils advocate as well.
It's easy to forget you have a range of choices when dealing with risks or opportunities, it's never back and white and ISO wants you to consider things with respect to the following 4 elements
When you are thinking about risks around say threats think about these things:
When you are looking at the upsides and your opportunities think about these:
The second part of ISO 9001:2015 Clause 6.1 says that you shall (i.e. you must) to create a plan to address the risks & opportunities that you have identified , you must
We have created a simple excel template that you can use to map out your analysis of your SWOT quickly and methodically so you can both action what you need to but also clearly demonstrate the steps you have taken to keep the auditor happy as well!
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