Identify Issues and Opportunities with Management Review Software
QT9 simplifies ISO and FDA compliance with centralized, audit-ready management review tools.
Centralize All Inputs
Collect required review data from across your QMS.
Track Action Items
Assign and monitor tasks directly from review findings.
Meet ISO Standards
Simplify ISO 9001 & 13485 management review req.
Save Review History
Maintain a complete record of every management review.
Enhance Visibility
Provide leadership real-time access to performance metrics.
Simplify Audit Prep
Always be ready with documented review evidence and decisions.
What is management review software?
Management review software helps organizations plan, conduct and document management reviews required by quality standards like ISO 9001, ISO 13485 and FDA regulations. It centralizes review inputs, outcomes and action items, ensuring leadership stays informed and compliant.
QT9’s Management Review application streamlines review processes by integrating real-time data from across your QMS, including audits, CAPAs, feedback and objectives. It automates task assignments, tracks decisions and stores full review history, making it easy to demonstrate compliance and drive continuous improvement.
Transform your organization with management review tools
Accelerate quality management processes and adapt to new regulations through a single interface.
Auditor-Friendly
Easily collect the necessary data for a successful ISO audit.
Email Alerts
Automated email alerts and reminders for tasks and sign offs.
Real-Time Reporting
See the status of management review records and track the full history of records.
User-Defined Fields
Create unlimited custom fields for tracking company-specific information.
Assign Action Items
Assign users action items from any part of the management review.
Overdue Alerts
Get email alerts when corrective/preventive actions are overdue.
Interlink Modules
Link Management Review data and processes with related tasks.
Attach Related Files
Attach an unlimited number of files to your projects.
Electronic Records
Reduce paper usage and improve ease of access to management review records.
Get end-to-end quality management
FAQ: Management review
Management review is a formal process for top management to assess the performance of a company’s quality management system. It is required by many regulatory standards, including the International Organization for Standardization’s ISO 9001:2015, which states that “Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.”
Management review is a mandate required by several manufacturing standards and Life Sciences regulations, including:
- ISO 9001
- ISO 13485
- FDA 21 CFR Part 820
- ICH Q10
Beyond simple compliance, an official management review supports organizational goals by identifying opportunities for improvement to the system or to business strategies.
The timing and staff involvement of a management review is determined by the organization and the regulations to which it must maintain compliance. In general, management reviews involve an examination of inputs, such as customer feedback, nonconformities and corrective actions; audit results; supplier performance; KPIs; and operational performance.
Management review results must be documented and include opportunities for improvements, necessary policy and procedure changes, and any changes to resource needs.
Quality management review software provides a centralized platform for the planning, execution and documentation required for management reviews, with real-time data for a more accurate picture of the quality management system. Automating the workflows that make up the review process helps ensure that data and documents needed for a management review are properly compiled.
QT9 QMS’s integrated applications collect quality data from operations, nonconforming products , audits, customers, suppliers, and other connected data sources for simplified management review. Real-time data provides an up-to-date picture of progress toward strategic goals and allows for more evidence-based decisions.
QT9 QMS includes more than 25 standard modules that connect to provide simplified quality management end-to-end. 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.
With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.
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