What’s The Role of Risk Control Parameters in ISO 9001 (QMS) Quality Management Systems?

What’s The Role of Risk Control Parameters in ISO 9001 (QMS) Quality Management Systems?

ISO 9001, the internationally recognized standard for quality management systems, places a significant emphasis on managing risks to enhance organizational resilience and performance. While the standard primarily focuses on ensuring quality products and services, the incorporation of risk control parameters is a critical aspect that organizations need to consider. This article explores the pivotal role of risk control parameters within the framework of ISO 9001, highlighting their importance in achieving and maintaining high-quality standards.

Understanding Risks in ISO 9001:

In the context of ISO 9001, risks are uncertainties that can affect an organization’s ability to achieve its quality objectives. These uncertainties can stem from various sources, including internal processes, external factors, or changes in the business environment. ISO 9001 recognizes the dynamic nature of businesses and emphasizes the need for organizations to proactively identify, assess, and manage risks.

Risk Control Parameters:

The integration of risk control parameters in ISO 9001 signifies a proactive approach to quality management. These parameters serve as predefined measures and indicators that organizations use to monitor, control, and mitigate risks effectively. They act as a set of guidelines and thresholds, helping organizations stay within acceptable risk levels while striving for continuous improvement.

Identification and Assessment:

The first step in incorporating risk control parameters is the identification and assessment of potential risks. ISO 9001 encourages organizations to systematically identify both internal and external risks that could impact the quality management system. Once identified, these risks are assessed based on their likelihood and potential impact. Risk control parameters are then established to guide organizations in managing these risks in a structured manner.

Defining Tolerances and Limits:

Risk control parameters involve defining tolerances and limits for various risk factors. These parameters are customized to the specific needs and characteristics of each organization. Tolerances set acceptable levels of risk that an organization is willing to tolerate, while limits establish the boundaries beyond which actions must be taken to control or mitigate the identified risks.

Monitoring and Measurement:

Continuous monitoring and measurement are crucial components of effective risk management in ISO 9001. Risk control parameters facilitate ongoing evaluation of identified risks against established tolerances and limits. By regularly assessing these parameters, organizations can identify trends, deviations, or emerging risks, allowing for timely interventions and adjustments to maintain quality standards.

Mitigation and Improvement:

When risks exceed established tolerances or limits, organizations must implement mitigation strategies. ISO 9001 emphasizes a proactive approach, encouraging organizations to develop contingency plans and corrective actions to address identified risks promptly. The integration of risk control parameters ensures that organizations not only manage risks reactively but also take proactive measures to prevent or minimize potential negative impacts.


In conclusion, ISO 9001 places a strong emphasis on risk management as a key component of effective quality management systems. The incorporation of risk control parameters within this framework provides organizations with a structured approach to identify, assess, and manage risks. By defining tolerances, setting limits, and establishing proactive monitoring processes, organizations can navigate the dynamic business environment while maintaining high-quality standards. Embracing risk control parameters not only aligns with ISO 9001 requirements but also fosters a culture of continuous improvement and adaptability in the pursuit of excellence.

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