Frequently Asked Questions: Management Review
What is management review in quality management?
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.”
Why is management review important in quality management?
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.
What does management review involve?
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.
What is quality management review software?
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.
How does QT9 QMS simplify the management review process?
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.
