Managing risks during the ISO 9001 certification process ensures that the good practices of the standard are properly implemented within the company, guaranteeing real improvements and enhanced results by the end of the process. In addition, proper risk management will help ensure that deadlines are met and that the certificate is successfully obtained.
On the other hand, the lack of such management can hinder not only the implementation but the entire organization. After all, creating a Quality Management System (QMS) based on ISO 9001 requires profound changes. Without proper planning, these changes may disrupt processes, cause non-conformities, and harm employee productivity with excessive or unnecessary interruptions.
That’s why, in today’s content, we will address this topic and provide some tips on how to manage risks during the ISO 9001 certification process. By the end of this article, you will have a clearer view of the implementation process and understand how to make it run more smoothly and without unforeseen issues. With that said, let’s get started!
It All Begins with Training and Capacity Building
The first risk we face is the incorrect understanding of the standard and its requirements. When the standard is not correctly understood, processes, procedures, and activities are created that do not add value to the organization and may even negatively affect certification audits.
Mapping the Risks in the ISO 9001 Certification Process
Every risk management process starts with mapping. Therefore, map the implementation activities in detail, looking for factors that might hinder the process or that could be opportunities to make it easier, faster, and more efficient.
To do this, involve your employees—especially the process operators. This approach ensures that any new activities and control points are better implemented and truly become part of people’s daily routines. Moreover, it might be beneficial to involve other stakeholders to identify risks based on their experiences and perceptions.
Each context presents different risks, according to the company’s reality. However, for illustrative purposes, some risks include:
- Lack of commitment from top management;
- Inadequate or insufficient training and capacity building;
- Lack of resources (financial, human, or technological);
- Resistance to change regarding the standard’s requirements and its activities;
- Inadequate selection of the certifying body;
- Delays in the implementation schedule;
- Lack of documentary evidence for compliance with the standard’s requirements;
- Inefficient, flawed, or non-existent internal audits;
- Among others.
Each of these risks represents a threat to the ISO 9001 certification process. Depending on the severity of their occurrence and impact, they could even render the process unfeasible, resulting in the worst-case scenario: not obtaining (or losing) the ISO 9001 certificate.
Mitigating or Eliminating Risks
Once mapped, you will have an overall view of the risks in the certification process. In some cases, it will be necessary to return to the planning phase and modify it—changing actions and even the schedule.
However, in most cases, it will be sufficient to create action plans to mitigate or eliminate the previously mapped risks. Develop specific plans for each risk, always focusing on those with the highest impact and prioritizing according to your organization’s capabilities. Additionally, always assign clear responsibilities, set specific deadlines, and determine the necessary resources (allocating them as needed).
Finally, for less critical risks, it is worth evaluating whether they can be accepted or simply monitored without immediate actions. This approach can speed up the ISO 9001 certification process and may even make it more cost-effective.
Read – Risk Management: Avoiding Losses and Seizing Opportunities
Monitoring Risks in the ISO 9001 Certification Process
Some risks may be eliminated even before the implementation process begins.
One possible risk, for example, is that the QMS documentation might not be found during audits or could become lost or deteriorate in the company’s files. To eliminate this risk, you can use cloud repositories or invest in document management software. This way, the risk is removed.
However, some risks cannot be completely eliminated, so it will be necessary to monitor them to ensure that, even if they occur, they do not have negative consequences on the process or their impacts are minimized. For example, even if an excellent awareness campaign is conducted, it is still possible that some employees may resist the changes proposed by the standard.
In such cases, it is essential to closely monitor the implementation process to ensure that this resistance does not negatively affect the certification process, while also implementing improvements to further reduce these risks. This not only keeps the process on track but also enables the company to achieve real improvements!
Managing Today to Reap Results Tomorrow!
It is important to note that while this discussion focuses on quality management, these risks can also occur in other management systems, such as ISO 14001, ISO 27001, or ISO 41001. Moreover, managing risks in the certification process—whether for ISO 9001 or others—will bring benefits far beyond the implementation phase.
Many risks that are not mapped and addressed during system implementation persist during process execution and are much more difficult to manage in the long term. Eliminating them at the root of certification not only brings immediate results but also prevents future losses and rework.
Thus, by mapping, mitigating, and monitoring risks from the very beginning, it is possible to create a solid foundation that not only ensures immediate success but also facilitates continuous improvement over time. Risk management enables us to adapt quickly to changes, minimize failures, and seize opportunities for improvement, resulting in greater efficiency, cost reduction, and a more robust organizational culture!
