The ISO 9001:2015 quality management system has a strong focus on risks and opportunities. In addition to this, the 7th success factor in an ISO 9001 quality management system is looking at the effectiveness of your controls and the controls that you’ve identified to manage your risks.
To successfully implement an ISO 9001 quality management system you need to incorporate a risk based thinking approach to developing your strategic plan in your organization. This can be incorporated with a SWOT analysis, your business plan, and in turn looking at the effectiveness of the controls.
For example: If something is always happening that’s negative, or there’s this customer complaint that always comes up- these are good indicators that the controls that you have in place are failing.
So how can you identify these risks?
Having a think about analysing, recording and reporting the indicators around common complaints, common issues, recalls, product faults, defects, service faults, service problems, people issues, customer issues, are all example of important things that you could record and report on and then ask yourself how can we improve customer satisfaction.
How could we minimize customer complaints? What could we do to improve the customers experience? What could we implement to improve the customers experience?
In turn, it’s important to keep a range of statistics to monitor and measure the effectiveness of the controls implemented. The most important part here is the implementation and execution, it’s implementing and executing the positive activities.
What are the preventative actions to manage the risks? The strengths, weaknesses, opportunities and threats that you have identified in your SWOT analysis and risk assessment as you’ve built out your business plan and your strategic plan.
Identifying risks and opportunities in your ISO 9001 quality management system should incorporate your SWOT analysis, your business plan, strategic plan and then the risk assessments you have undergone for those.
If you want to go more in depth into risk based thinking and you want to think more about what’s a SWOT analysis, what should be the strategic objectives of the organization, take a look at our ISO 9001 Essentials Course over in our online Training Academy, as well as our ISO 9001 Gap Analysis checklist.