QMS 9001 Risk Register Template

by Kishan Tambralli

What is Risk Register?

Risk Register is a key document in QMS 9001. It captures risks and opportunities identified in the organization and records the associated controls. The objective of maintaining a Risk Register is to ensure that risks are managed proactively, effectively and continually.

QMS 9001 Risk Register

The Risk Register must be reviewed at planned intervals, but not less than annually, to ensure that it remains current and aligned with the organization’s risk management strategy.

The register should include:

  • Identification of risks and opportunities.
  • Risk analysis.
  • Risk response.
  • Residual risks.

The purpose of the QMS 9001 risk register is to help the organization understand the potential impact that risks may have on its ability to achieve its objectives and put in place mitigation strategies to reduce those risks. 

It is typically used as part of a risk management process and can be customized to fit the specific needs of an organization. The QMS 9001 risk register should include information on the following:

  • Risk description: What is the nature of the risk?
  • Risk probability: How likely is it that the risk will occur?
  • Risk impact: What are the potential consequences if the risk occurs?
  • Risk causes: What factors could contribute to the occurrence of the risk?
  • Risk controls: What measures are in place to mitigate or reduce the risk?
  • Responsible person: Who is responsible for monitoring and managing the risk? 

Risks And Opportunities In QMS 9001

QMS 9001 is a quality management system that provides a framework for organizations to maintain and improve the quality of their products and services. It also helps to ensure compliance with statutory and regulatory requirements. The standard can be applied to any type of organization, regardless of size or industry.

There are several benefits associated with QMS 9001, including improved customer satisfaction, increased efficiency and productivity, and reduced costs. However, there are also several risks and opportunities associated with the standard.

The risks and opportunities associated with QMS 9001 should be considered when planning and implementing the standard. Organizations should have a clear understanding of these risks and opportunities before they begin to implement the standard.

One of the most important aspects of QMS 9001 risk register is its focus on continuous improvement. This means that organizations must continually review and improve their quality management systems to maintain or improve their performance.

Organizations should also consider the potential for adverse effects when implementing QMS 9001. Adverse effects can include increased costs, decreased customer satisfaction, or even litigation. To avoid these potential problems, organizations should carefully consider all the risks and opportunities associated with the standard before they begin to implement it. It’s important to note that not all risks and opportunities are created equal. Some may be more significant than others, and it's up to the discretion of the company to decide which ones are worth pursuing. Ultimately, the goal is to create a balance between mitigating risks and exploiting opportunities, to maximize the overall success of the business.

What Is Risk Register Used For In QMS 9001?

A QMS 9001 Risk Register is a document used to list, assess and track potential risks to a business or project. In the context of quality management systems (QMS), it forms part of an organization's risk management procedure and can be used to identify the potential hazards associated with product or service provision. By assessing these risks and putting in place controls to mitigate them, an organization can reduce the possibility of negative impacts on its customers and client base.

A risk register may be used for any type of project but is particularly common in those which are large or complex, or where there is a high degree of uncertainty. Many businesses use risk registers as part of their ISO 9001 quality management systems.

The first step in creating a risk register is to identify the potential risks associated with a project or business activity. These can be drawn from a variety of sources, including market analysis, experience with similar projects, and expert opinion. Once identified, the risks should be assessed in terms of their likelihood and potential impact.

ISO 9001

QMS 9001 Risk Register Template

Once the risks have been identified and assessed, controls can be put in place to mitigate them. The level of control will depend on the severity of the risk; for example, a very high-risk item may require multiple controls, while a low-risk item may only require a single control.

The QMS 9001 risk register should be reviewed regularly and updated as new information arises or as the project progresses. It is important to ensure that the controls in place are adequate to deal with the risks identified.

There are various ways to create a risk register; one common approach is using a table with three columns:

  • Risk: A description of the potential risk.
  • Likelihood: A numeric value or rating that represents the likelihood of the risk occurring.
  • Impact: A numeric value or rating that represents the potential impact of the risk, if it were to occur.

Once all potential risks have been identified and rated, they can be prioritized based on the combined score of likelihood and impact. The risks with the highest scores should be given priority in terms of mitigation.

How To Create Risk Register In QMS 9001?

A risk register template is an essential for quality management system 9001. It is a systematic way of documenting and tracking risks, which allows you to identify, assess, and control them. To create a risk, register in QMS 9001, you will need to follow these steps:

  • Establish the scope of your risk register. This includes specifying what types of risks you will document (process risks, product risks, performance risks, etc.), who will be responsible for documenting and managing the risks, and how often the register will be updated.
  • Identify the risks associated with your quality management system. This can be done through brainstorming sessions, process mapping, or conducting audits.
  • Assess the risks in terms of their likelihood and potential impact. This will help you prioritize which risks need to be addressed first.
  • Control the risks by implementing appropriate countermeasures. These may include process changes, training programs, or technological solutions.
  • Monitor and review the risk register on a regular basis to ensure that it remains up-to-date and effective.

Benefits Of Risk Register Of QMS 9001?

Implementing a QMS 9001 risk register can help an organization to identify and assess potential risks to their quality management system (QMS).

Some benefits of using a risk register include: 

  • The ability to better understand and manage risks.
  • Helps to improve organizational performance.
  • Can improve customer satisfaction.
  • Can improve safety and quality of products or services.
  • Improved visibility of risks and their potential impacts on the business.
  • Better understanding and management of risk appetite.
  • Increased ability to make informed, data-driven decisions.
  • Enhanced risk awareness throughout the organization.
  • Streamlined and consistent risk management process.
  • Improved communication of risk information.
  • Increased efficiency and effectiveness of risk management.
ISO 9001