Cloud-based risk management software — available anytime, any place.

Easily conduct risk investigations and centrally manage records for greater efficiency.

Automate risk management

Minimize risk and eliminate manual processes.

User-friendly reporting

Assist with data mining & trend analysis with charts & graphs.

Connect & collaborate online

Cross-link & centralize all your quality requirements.

Link to multiple modules

Create risk assessments from over half of the modules in QT9 QMS.

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Free up time with risk assessment tools built-in to QT9™ QMS.

QT9's risk management software is your all-in-one solution for better risk assessment records.

Manage Approvals

Assign approver/s and approve, reject or verify risk assessments.

Email Alerts

QT9 QMS sends users email alerts and reminders based on your settings.

Real-Time Reporting

Track your risk assessments by risk categories and risk scores.

Paperless Made Effortless

Easily export and email copies of risk assessments.

Assign Tasks

Create unlimited tasks per risk assessment.

User-Defined Fields

Create unlimited custom fields for tracking your company-specific information.

Overdue Alerts

QT9 QMS sends email alerts when risk assessment actions are overdue.

Attach Related Files

Attach unlimited files to any risk assessment.

Manage Risk Categories

Set category levels for risk assessments based on due dates within your organization.

Explore 25+ Modules Included

Frequently Asked Questions: Risk Management

What is risk management?

Risk management is the process of identifying, analyzing, mitigating or resolving risks that could affect the quality and safety of goods and services. By implementing robust risk management processes, quality control professionals can systematically identify, assess and mitigate potential risks throughout the product lifecycle.

What is the relationship between quality and risk management?

More than ever, quality oversight calls for incorporating risk planning and mitigation into quality management systems from day one. This proactive approach enables manufacturers to anticipate and address issues before they escalate, thereby safeguarding product quality, enhancing regulatory compliance and protecting brand reputation. Integrating risk management into quality control practices enhances product quality and also fosters a culture of continuous improvement and innovation.

What are risk management standards and regulations?

There is a strong emphasis on risk management in quality standards that is accepted globally. The most common of these are ISO 9001 and ISO 13485, maintained by the International Organization for Standardization (ISO), and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 820. These standards call for incorporating risk-based thinking at all points in a product’s lifecycle. More structured risk-management processes for medical devices are outlined in ISO 14971.

What are risk management procedures?

In general, risk management procedures involve:

  • Identifying potential risks
  • Conducting risk analysis
  • Planning a response
  • Implementing response
  • Evaluating effectiveness
How can QT9 help with my risk management needs?

QT9 QMS provides an integrated platform where you can create risk assessments from other QT9 modules, including FMEA, corrective actions, nonconforming products, engineering change requests and customer feedback records.


QT9 QMS has 25-plus modules that come standard. Its cloud-based platform enables you to keep track of risk management activities and synchronize records with anyone, anywhere.


QT9 QMS is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.


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Get a real-time view of your risk assessment records.

Sign in to QT9's Risk Management Software anytime, anywhere to get a real-time view of your risk assessments.

Built-In Dashboard

Quickly view the status of risk assessment records from the QT9 dashboard & easily personalize the view.

Risk Assessment Integration

Risk assessments can be created from other QT9™ modules including corrective actions, nonconforming products, engineering change requests and customer feedback records.

Traceability & Transparency

QT9™ QMS includes web portals for customers, suppliers and employee training.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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