ISO 9001 And Actions to Address Risk and Opportunities
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.
Building On Previous Work
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:
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
- How you will give assurance that your Quality Management System will achieve it's intended results.. i.e. you will do what you say
- That "desirable effects" i.e. the upsides will be enhanced - so more of the good stuff (think Good to Great!)
- Prevent or reduce undesired effects - so less of the bad stuff
- Achieve improvement - yep.. it's PDCA time again!
When you are thinking about risks around say threats think about these things:
- How can you actually Eliminate what is causing the risk
- Is it possible to Change the likelihood of the risk coming to pass or consequence/s that occur?
- How can you just Avoid the risk altogether
- Can you reduce it by Sharing the risk with perhaps a partner or client?
- Accept that it's just a risk of business so make the decision to Retain the risk by informed decision
- Just do it anyway - Yep knowing what you know about the risk do it anyway to pursue an opportunity
When you are looking at the upsides and your opportunities think about these:
- Can you Adopt new practices to get the benefit
- Should you Launch new products to grow a market?
- Perhaps you can Open new markets altogther
- Perhaps you can attract new customers
- Build partnerships to spread risks at the same time as opening opportunities
- Use new technology to give you that advantage or save on costs
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
- Integrate & implement the actions into your Quality Management System processes
- Evaluate the Effectiveness of these items
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