Why Risk Identification is Important for Gaining ISO 9001 Certification

“Quality is never an accident. It is always the result of intelligent effort”- John Ruskin

Quality defines the efficiency of an organization. It cannot be achieved overnight, as it requires continuous hard work and dedication. The International Organization for Standardization or ISO introduced ISO 9001 certification to help organizations ensure quality in their business processes. Implementation of an efficient quality management system or QMS is a major requirement of the ISO 9001 standard, and the latest version, ISO 9001:2015, has insisted on a risk-based approach.

Identifying and setting up quality controls is a critical step to a risk-based approach with the ISO 9001 standard. This standard asks organizations to identify risks, create a plan to address the risk, and integrate it into the QMS. With each identified risk comes a required assessment that will determine the severity of the risk. Additionally, organizations must evaluate the effectiveness of their risk management plans.

It is important to combine the risk assessment with an evaluation of potentiality of risk and whether it is possible to detect the problem. Organizations can obtain the risk priority number or RPN from the Failure Modes and Effects Analysis (FMEA), which will help organizations determine the significance of each identified risk for the QMS.

The risk controls must match the identified risk significance; this way an organization can ensure risk-based thinking works for their organization. Initially, a standard risk control structure should be developed, where the appropriate controls for each risk are determined. Using this risk significance process is the best way to determine what level of control is required. Once the controls are identified and incorporated, the chance of achieving ISO 9001 certification will be increased.

The standard control structure should be developed with six risk strategies, which are listed below:

1. Risk Retention by Informed Decision

The best strategy for dealing with insignificant risks is to accept the risk and continue the process. When a risk has a low chance of happening or is not severe, then acceptance is the best approach. However, when a avoidable measure is expensive or time-consuming, it must be determined whether it is worth the required resources to implement it.

2. Avoiding Risk

Preventative actions must be initiated when dealing with significant risks, and the chance of significant risks must be reduced. This could be achieved with an improvement in the process, replacement of old devices with new and efficient ones, or the elimination of the component creating the risk. Once these avoidance actions have been taken, the risk will no longer exist.

3. Risk Source Elimination

Some organizations eliminate the risk source to effectively avoid the risk. This may involve changing a part used in an assembly or removing a risky process step and supplanting it with a less risky one.

4. Risk Sharing

Risks can be transferred, for example, when a process is executed by an expert supplier rather than inside the organization. Another way to share risk is by having insurance that provides essential additional resources that can be utilized when responding to risks.

5. Changing the Consequences

Mitigation is widely used when dealing with risks. Some examples of risk mitigation include implementing administrative controls, training, or additional inspections. These measures do not necessarily stop the risk from happening, instead it increases the chances of identifying the risk before it occurs. Mitigation may also include implementing plans to change any risk consequences once a problem has occurred.

6. Risk Acceptance to Pursue an Opportunity

Risk always has an impact on organizations, however, the impact is not always negative. It may provide an opportunity that can be capitalized on.

How to Implement the Identified Controls

A critical element of risk control is that it should ensure required actions to address the issue are incorporated in the QMS. In this context, it is important to note that process improvement or the addition of new devices will not work if the employees using them are not properly trained to to leverage benefits out of these improvements.

A Final Takeaway

An organization must ensure it does not go overboard with putting controls in place for insignificant risks. The key to success in risk management is to understand what controls are required for the identified risks. By implementing controls with significant risks, and properly incorporating controls into the QMS, employing a risk-based approach to improve the QMS will become easier.
Risk identification enables organizations to eliminate any difficulties and utilize the opportunities that come with ISO 9001 certification.

Want to learn more about risk-based approach? Get in touch with our experienced ISO 9001 certification consultants!