QMS Risk Management (ISO 9001) Word Template

by Kishan Tambralli


Risk management is a critical part of the quality management system (QMS). It is the process of identifying, assessing, and controlling risks to ensure that products meet customer requirements and comply with applicable regulations. We will discuss QMS Risk Management and its fit into the overall QMS framework. We will also provide a detailed explanation of each step in the QMS Risk Management process.

The purpose of QMS Risk Management Template is to identify, assess and control risks to ensure that products meet customer requirements and comply with applicable regulations. Risk management is an essential part of the quality management system (QMS). The process involves identifying hazards or potential problems, assessing their severity and likelihood of Occurrence, then taking action to prevent them from occurring.

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This Include:

  • Identification
  • Assess
  • Control

Risk Management Process 

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  • Identification:
    The identification process is one of the essential steps in the risk management of a quality management system. This process helps identify potential risks and hazards that could affect the product or service quality. By identifying these risks, businesses can mitigate them and reduce the chances of causing any damage or problems.
    The first step in the identification process is to gather information. This includes reviewing any existing documentation or data and interviewing employees and stakeholders. It is essential to collect as much information as possible to get a clear picture of the present risks. Then, once all of the information has been gathered, it needs to be analyzed.
  • Assessment:
    QMS Risk management is a systematic approach to identifying, assessing, and prioritizing risks followed by developing and implementing risk treatment plans to reduce or eliminate the risks to an acceptable level. In a quality management system, risk assessment is one of the essential processes. It helps identify potential hazards and threats that can impact the quality of products or services. The risk assessment process involves:
  1. The identification of risks.
  2. Determination of their severity and likelihood of Occurrence.
  3. Selection of appropriate actions to mitigate them.
  • Control:
    To ensure that quality objectives are met, it is necessary to identify and assess risks and put controls to mitigate them. The control process involves preventing or correcting any deviation from the desired outcome. By effectively managing risk, you can protect your organization's quality reputation and ensure compliance with regulatory requirements.
  • Evaluation:
    To manage risks effectively, an organization must first understand the process of evaluation involved. This includes assessing the hazards and risks associated with activities, products, and services and determining the controls to mitigate those risks. Without a comprehensive understanding of risk evaluation, it would be difficult for an organization to make informed decisions about allocating its resources to ensure quality and safety.
  • Reduction:
    To reduce the risk of potential problems, companies use various techniques and practices as part of their overall QMS Risk Management process. One such technique is reduction, which eliminates or minimizes potential risks. In the context of quality management systems (QMS), reduction means taking steps to reduce the likelihood that defects will occur in products or services.
    One common way to reduce the risk of defects is to implement preventive controls. These are measures taken before a product or service is delivered to customers to prevent problems from happening in the first place. For example, a manufacturer might use quality inspection procedures and process controls to ensure that products meet customer requirements.
  • Acceptance:
    The process of acceptance is an essential part of QMS Risk Management for quality management systems. To ensure that risks are managed effectively, it is necessary to have a plan for accepting or rejecting products, services, and processes. This can be a challenge, especially in situations where there is a lot of pressure to receive products that may not meet the required standards.
  • Communication:
    Risk communication is a critical process in QMS Risk Management. It involves exchanging information between the organization and its stakeholders about risks and potential risks. This information helps stakeholders understand the risks, make informed decisions, and act if necessary.

    The first step in risk communication is identifying the risks. This can be done through various methods, such as hazard identification, fault tree analysis, and impact assessment. Once the risks have been identified, the organization needs to develop a plan for communicating these risks to its stakeholders. This plan should include who will display the information.
  • Risk Review:
    Risk review is a process used to identify, assess, and manage risks in a quality management system. This process helps to ensure that risks are identified and addressed early on before they have a chance to cause any problems. The risk review process involves:
  1. The identification of hazards.
  2. The assessment of associated risks.
  3. The implementation of controls to mitigate those risks.

    It is important to note that the risk review process should be ongoing and updated as new risks are identified, or conditions change.

Why Quality Risk Management Is Essential In  QMS

One of the most important aspects of any quality management system (QMS) is quality risk management. This process helps identify potential risks to product quality and outlines steps to mitigate or eliminate those risks. Quality Risk management is essential to ensure that products meet customer requirements and specifications.
One of the essential benefits of Quality Risk Management Template is that it helps ensure product quality. QRM can help reduce the number of defective products released into the market by identifying and mitigating potential risks. This can improve customer satisfaction and help protect your company's reputation and bottom line.
One of the key benefits of using a risk-based approach to quality management is that it allows organizations to focus their resources on those areas that pose the most significant risk.

Who Is Responsible?

  • The role of the Quality Assurance Manager in risk management is critical to ensure that all risks are identified and analyzed and that corrective actions are taken when necessary. The QA Manager is responsible for ensuring that the processes in the quality management system are suitable, adequate, and effective.
  • They also present updates on the QMS Risk Management process at the Management Review.
  • This is a critical function in any organization, and the QA Manager must effectively manage risk.

Examples of Risk Management Template

ISO 9001

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  • Risk Analysis:
    Risk Analysis is the process of identifying potential hazards and threats to a company's quality management system. It is an integral part of risk management and allows businesses to identify areas vulnerable to problems or defects. By understanding the risks involved in their operations, companies can protect themselves against potential issues.
  • Probability of Occurrence:
    The probability of Occurrence is a critical concept in QMS Risk management. To make informed decisions about managing risks, it is essential to understand the likelihood that a particular threat will occur. The probability of Occurrence can be expressed in different ways, depending on the context. For example, in quality management systems (QMS), the likelihood of Occurrence is often used to calculate the Risk Priority Number (RPN).
    The definition of probability of Occurrence can be tricky to understand. It is often confused with the concept of risk. The probability of Occurrence is the likelihood that a particular risk will occur, while the risk is the potential negative outcome of an event.
  • Risk Matrix:
    A Risk Matrix of Risk Management Word Template is a diagram that visually displays the relationship between risks and the corresponding risk management controls. It allows you to see at a glance how well your risk management controls are working. The Risk Matrix is also used to identify potential gaps in your risk management controls.
    It can be calculated by Risk x probability of Occurrence
  • Essential Registry of Risk and Opportunities:
    The essential registry of risk and opportunities (KRRO) is a critical component of enterprise risk management. It helps organizations identify, assess, and manage risks and opportunities. The KRRO contains a list of all key risks and opportunities that the organization faces and their respective impact and likelihood scores. This allows businesses to make informed decisions about best allocating their resources to minimize risk and maximize opportunity.

    The KRRO is updated regularly to ensure that it reflects the latest changes in the business environment. It is also used for risk reporting and forecasting. By tracking key risks and opportunities, organizations can better anticipate potential problems and seize new opportunities. As a result, the KRRO is essential for any successful enterprise risk management program.
  • Criteria for determining Risk and Opportunities:
    The Criterion for Determining Risk and Opportunity in a Quality Management System is a document that guides on identifying, assessing, and prioritizing risks and opportunities. This document is essential for businesses who want to ensure that their quality management system effectively identifies potential problems and takes corrective action.
    The Criteria for Determining Risk and Opportunity in a Quality Management System is based on the following principles:
  1. Risk and opportunity identification should be proactive, not reactive.
  2. Risks and opportunities should be identified at all levels of the organization.
  3. Risks and options should be evaluated using risk management.
  • Risk Evaluation:
    Risk evaluation is the process of assessing and managing risks to quality. To do this effectively, you must first understand what a chance is. A hazard is anything that could potentially affect the quality of your product or service. This can include defects, customer complaints, poor performance, and more.

    By identifying and addressing risks early on in the process, you can prevent them from causing serious problems down the road. Risk evaluation is an integral part of quality management, and it should be a top priority for any business that wants to ensure the quality of its products and services.
    By implementing a risk evaluation process, businesses can identify areas where they may be at risk and take steps to mitigate those risks.
  • Risk Acceptance:
    Risk acceptance is a process in quality management systems (QMS) that allows an organization to decide whether or not to take a risk. This decision is based on the potential benefits and risks associated with the risk in question. If the benefits outweigh the risks, the organization will accept the risk. If not, then they will reject it.
  • Risk Review:
    Risk Review is a process in quality management systems (QMS) that assesses the potential risks to the organization and determines whether they are acceptable. This process is essential because it helps ensure that the organization is aware of any potential dangers and can mitigate them.

Top 5 Benefits

A QMS helps businesses identify and mitigate risks, which can lead to some benefits, including:

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  • Improved product quality.
  • Reduced costs.
  • Increased customer satisfaction.
  • Reduced liability exposure.
  • Enhanced brand reputation.
ISO 9001