How an Organization should Develop Risk Control Structure for ISO 9001:2015?

Go through this article to learn how an organization should create an effective risk control structure for ISO 9001:2015.

ISO 9001:2015 has insisted on identifying and implementing controls. Whenever you are identifying a new risk, you should assess the severity of the detected issue. Nowadays, most of the companies tend to combine a prediction analysis of how likely risk is to happen with their Quality Management planning. By combining these two vital elements, you will be able to fulfill a requirement of ISO 9001:2015- implementation of a risk-based quality management system. We have already discussed a lot about how to achieve ISO certification; in this article, we will focus on how to make a risk-based quality management system (QMS) as per the latest version of ISO 9001:2015.

When it comes to making a risk-based QMS, it is important to develop a standard risk control structure. Once you know which the significant risk factors are, you would want to find out the right controls for dealing with each of the risks. How should you do it? First, you should list the risks according to their significance or priority. This list will enable you to understand what level of control is required for a particular risk. This is the initial stage. After this stage, you may need to consider six vital aspects to identify the risk controls. Let’s have a glimpse of these six vital aspects:

What should you do when an insignificant risk comes to your way? The best way is to accept the risk factors and further proceed. If you find a risk factor having a very low chance of taking place in reality, or you identify a less severe risk, then it would be the best decision to react to the issue only. You can do the same when a possible avoidance measure is found to be costly and time-consuming.

We have discussed how to deal with insignificant risk. Now, we will be discussing how to avoid significant risk. For dealing with the significant risks, you may initiate some actions to prevent the risk from happening. Moreover, you may need to change the chance of occurrence. This change could be a change in the process, replacement of old equipment with advanced equipment, modification of a design to eliminate a component that may cause the risk, etc. Once, you initiated to avoid a significant risk, the risk will no longer exist.

Whenever you are looking for any ISO certification, be it ISO 9001 certification, ISO 13485 certification, or similar other certification, you should categorize the risks as per their significance.

By eliminating the risk source, you will be able to get rid of that particular risk. Sometimes, such elimination may require a change in the used parts in an assembly. There is another way of transferring risk. You may consider having insurance that would offer additional resources for resolving a risk.

You may transfer a risk if it is required. For instance, you are hiring an expert to deal with a particular process rather than doing it on your own. Apart from having insurance in place, you can ask experts’ help to deal with an issue about which you do not have any expertise. While you are considering how to achieve ISO certification, it is also important to consider which areas may need expert consultation.

To mitigate a risk factor, you may need administrative controls, training programs, and additional auditing. Considering the priority, you may modify the consequences of these actions. This way you would not be able to stop the risks from happening, but you would be able to maximize the possibilities of identifying the risk after it takes place. A mitigation approach sometimes includes having plans, which can deal with the consequences of risks once they have happened.

We have discussed risks having a negative impact, but what would happen if the risks were treated just like an opportunity? For doing so, you should assess the risks against what you need to do for capitalizing on the opportunity. You need to initiate an action for making it happen.

Once you have identified the controls, this is high time you should implement them in your Quality Management Process. Aware of your employees about this implementation and train them properly so that they can be familiar with the system. In this context, it is important to note that enhanced processes or even new equipment would not be effective if the staffs who are using it were not well aware of how to utilize these controls.

After identifying and implementing the controls, you need to make your staffs keep practicing the controls. This way, you will be able to develop and maintain a risk-based Quality Management System as per ISO 9001:2015 standard.

Damon Anderson is a skillful ISO consultant having expertise in various ISO standards including ISO 9001, ISO 13485, ISO 17025, etc. He is currently associated with a top-notch ISO certification consultancy. He has often been asked by entrepreneurs and senior managers- “how to achieve ISO certification?” Therefore, he has decided to help people learn more about ISO certification, such as ISO 9001 certification and ISO 13485 certification through blogging. His blog is a powerhouse of knowledge relevant to the different ISO standards.

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