Risk Management Approach Under the ISO 9001 Standard

Identifying risks, eliminating them, or implementing controls to reduce their impacts is a critical aspect of the ISO 9001 quality management standard. It promotes risk-based thinking in businesses to help them recognize risks at each step or process, identify the source, and prevent them with appropriate measures. Risk management is a core aspect of quality management because it eliminates chances of substandard/poor quality products or services.

Effective risk management helps an organization to consistently determine the issues in their intermediate processes, inadequacies in their delivery systems, and flaws in input sources or supplies. With each discovered and mitigated risk, you are better able to guarantee product safety, quality and satisfaction to the customers. It is therefore an obligation for businesses today to have a standardized quality management system (QMS) that helps them to identify risks and keep them away.

Risk management in businesses under the ISO 9001 standard is a systematic approach that is followed after the risk assessment. Here are some key strategies that explain the approach.

Retention of Risks

When the risks identified have undisruptive or insignificant consequences, the organizations can just accept them and continue with their operations. They may also choose to retain the risks when avoidance measures are too expensive or extremely time-consuming and it is not worthwhile to waste any resources on them. However, in many cases, the organization needs to have a strategy to react to the risks when the consequences have the potential to be dangerous, disruptive, or otherwise damaging to the company or products.

Avoiding Risks

The next strategy is taking measures to avoid the risks that are significant and can severely impact the operations or quality of the end products. The organization needs to choose appropriate measures after assessment to prevent the risks from occurring. In other words, it can find actions to minimize the chances of their occurrence. They can do so by making an improvement in the concerned process where the risk is identified or replacing a process or equipment that is leading to the risk. The purpose of the avoidance strategy is to implement effective actions so that the risks prevail no longer.

Eliminating the Source of Risks

A crucial way to preventing the risks is eliminating their source of occurrence. This can be quite challenging for an organization because they might need to change a process, remove a process, or completely relocate the process. Naturally, there is a need for resources, planning, and time to make the necessary changes in the organization's processes to eliminate the source.

Sharing the Risk

Many times the nature of the risks is such that they can neither be avoided nor retained. In such cases, the organization needs to share the risks i.e. transfer it elsewhere where can be managed well. This means outsourcing the risks management to a quality assurance services agency or an external supplier. Another way of sharing risks is getting insurance for the process or equipment or people who can deal with the risks.

Reducing the Chances of Risks

Another method for risk management is reducing or minimizing the chances for their occurrences by using strong administrative controls. They can also be reduced by training the persons who are faced with the risks and undergoing frequent thorough assessments of the processes. In this case, risks are still bound to occur, but you are mostly able to identify them beforehand and take as many actions as possible to reduce their impacts.

Treating Risks as an Opportunity

The last strategy for risk management is taking a risk as an opportunity instead of treating it as a negative consequence for your organization. The organization needs to assess the risk, its source and impacts to decide the actions required for capitalizing on the opportunity out of it. In other words, it is exploiting the risks to bring up a process change or improvements in the organization that are going to benefit it in the long run.

These are the crucial strategies to handle risks in your organization to assure the quality of end products or services. However, you need to ensure that whatever actions you take for risk management are incorporated into your QMS. Whether there are new processes introduced, old processes improved, or new equipment used as measures to prevent risks, each of the organization's members must be aware of them and trained to on the changes. The ISO 9001 quality management standard includes risk management as one of its core principles and these strategies are helpful in making your risk-based approach in your QMS successful.