A Quality Management Review (QMR) is a formal process for top management to assess the effectiveness, suitability, and adequacy of the quality management system (QMS).
Management reviews allow Life Science companies to identify and address areas for improvement and ensure their QMS remains suitable, adequate, and effective for the company’s goals and objectives.
This article discusses the aspects of quality management review, including its definition, purpose, frequency, requirements, and contents. It also explains the role of QMS software in management reviews.
Life Science companies understand the complexity of quality management processes. Hence, companies are increasingly adopting QMS Software solutions to manage their quality processes, including providing a seamless approach to planning and capturing the details of their management reviews.
SimplerQMS provides fully validated eQMS software designed specifically for Life Science companies. You can book a free demo with one of our specialists to see how it can enhance your quality management processes.
This article will discuss the following topics:
- What Is a Quality Management Review (QMR)?
- What Is the Purpose of a Quality Management Review?
- Why Is Quality Management Review Needed?
- How Often Should a Quality System Undergo Management Review?
- Which Requirements Specify Quality Management Reviews?
- What Should Be Included in Quality Management Review?
- What Is the Role of QMS Software in Quality Management Reviews?
What Is a Quality Management Review (QMR)?
A Quality Management Review (QMR) is a formal process for assessing the effectiveness, suitability, and adequacy of the quality management system (QMS).
Quality management reviews an opportunity for top management to review the company’s QMS performance against its Quality Key Performance Indicators (KPIs), identify areas for improvement, and make decisions about allocating resources.
Below are the definitions of quality management review as specified in some of the most common standards, guidelines, and regulations.
- ISO 9001:2015: A QMR is a process conducted to determine a system’s suitability, adequacy, or effectiveness to achieve established objectives.
- ICH Q10: Quality management review is a formal process for periodically reviewing the pharmaceutical quality system.
- FDA 21 CFR Part 820: Management review is the review of the suitability and effectiveness of the quality system at defined intervals.
- ISO 13485:2016: The QMR is the top management review of the quality system at documented planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
What Is the Purpose of a Quality Management Review?
The main purpose of a quality management review is to identify improvement opportunities and ensure the company’s quality management system remains effective and aligned with its strategic direction.
The QMR addresses the possible need for changes to quality policy, objectives, and other quality management system elements.
Why Is Quality Management Review Needed?
Quality management reviews are essential for Life Science companies because they are required for regulatory compliance, as per ISO 9001:2015, 21 CFR Part 820, ICH Q10, and other requirements.
Life science companies must show proof that management reviews have been executed to demonstrate their commitment to the quality, safety, and efficacy of their products.
The QMRs also help companies address potential quality issues, which leads to developing and implementing solutions that help improve quality and safety and reduce costs.
How Often Should a Quality System Undergo Management Review?
Quality management systems should undergo periodic management reviews at least once a year to assess their effectiveness and ensure they are still meeting the company’s needs.
It is important to note that the requirements for quality management reviews do not specify a specific frequency. Instead, companies are given the flexibility to determine the frequency that is best for them based on their specific needs and circumstances.
Which Requirements Specify Quality Management Reviews?
Several requirements specify Life Science companies perform regular quality management reviews, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, and other requirements.
Below are Life Science requirements that specify the criteria related to quality management reviews in greater detail.
NOTE
This section will explore some of the requirements that mention quality management reviews. However, note that this list is not definitive. For official and comprehensive information, always refer to the requirements applicable to your company.
ISO 9001:2015
The international standard ISO 9001:2015 specifies the requirements for quality management systems. This is a versatile standard, not limited to a single industry, and can also be applied to the Life Science sector.
Section 9.3 requires top management to review the QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the company’s strategic direction.
The organization must keep documented information as evidence of the results of management reviews.
ISO 13485:2016
ISO 13485:2016 is an international standard that defines the requirements for a quality management system (QMS) specific to the medical device industry.
The standard specifies in Section 5.6 that companies must document procedures for management reviews. Top management must regularly review the quality management system to ensure it is still suitable, adequate, and effective.
The review should assess opportunities for improvement and the need for changes to ensure an ISO 13485:2016 compliant quality management system.
All records of management reviews must be kept.
FDA 21 CFR Part 820
The Food and Drug Administration (FDA) 21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines the Current Good Manufacturing Practice (cGMP) requirements for all finished medical devices intended for human use.
Section 21 CFR 820.20(c) specifies that management must review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
The goal is to ensure the quality system satisfies the FDA requirements and the manufacturer’s established quality policy and objectives.
Companies in compliance with the 21 CFR Part 820 quality system regulation shall document all dates and results of quality system reviews.
ICH Q10
The international guideline ICH Q10 describes a model for an effective quality management system for the pharmaceutical industry.
Section 2.6 establishes that top management should be responsible for controlling the ICH Q10 pharmaceutical quality system through quality management review to ensure that it remains suitable and effective.
Management should evaluate the findings of periodic management reviews of process performance, product quality, and the pharmaceutical quality system.
What Should Be Included in Quality Management Review?
The quality management review should include supporting documents, review inputs, and review outputs.
Supporting Documents
Supporting documents in the context of quality management reviews are any documents, records, data, or other materials that provide additional information or context to the review process.
These documents help to support findings, identify areas for improvement, and track progress over time.
Below are examples of supporting documents.
Quality Manual
The quality manual is a document that describes the company’s quality management system, including its purpose, scope, and key processes. It also describes how the QMS complies with the requirements of a specified quality standard, such as ISO 9001:2015 or ISO 13485:2016.
Overall, the quality manual provides a framework for assessing the effectiveness, suitability, and adequacy of the QMS.
Quality Policies
The policies are statements that define the company’s commitment to quality. It outlines the values and principles regarding quality and guides how to achieve quality objectives.
Meeting Minutes of Previous QMRs
Quality management review meeting minutes are documents of the decisions and actions taken during previous QMRs. They provide a historical record of QMR outcomes and help to track progress over time.
Standard Operating Procedures (SOP)
The standard operating procedure (SOP) is a document that provides high-level guidelines for a process. Following SOPs ensures that QMS processes are performed consistently and effectively.
Quality Records
The quality records provide objective evidence of the QMS in operation, documenting activities performed, and the results achieved. Records are important for QMRs because they provide proof that the QMS is meeting its requirements.
Work Instructions
The work instruction is a detailed step-by-step guidance document that provides instructions on how to perform a specific task. They provide evidence of how the QMS is implemented and controlled at the individual task level.
What Are the Quality Management Review Inputs?
Management review inputs are the various sources of information used to assess the effectiveness of the quality management system.
The following are examples of management review inputs based on ISO 9001:2015, ISO 13485:2016, and ICH Q10.
Changes That Could Affect the Quality Management System
Changes that could impact the QMS include changes to products, processes, and regulatory or customer requirements.
Identifying and assessing changes that could impact the QMS is important for ensuring that it remains effective and aligned with the company’s quality goals.
Customer Satisfaction and Feedback
Customer satisfaction and feedback documents are statements from customers, including complaints, suggestions, and compliments. They are essential to provide insights into how customers perceive the company’s products and services and how the QMS can be improved to meet customer needs.
Process Performance and Conformity of Products
Process performance and conformity of products are measurements of how well the company’s processes are performing and whether products and services are meeting requirements.
They are essential for ensuring that the QMS is meeting its objectives and that products and services meet regulatory and customer requirements.
Nonconformances and CAPAs
Nonconformances are events of a product, service, or process that do not comply with the established requirements. They are described in the nonconformance reports.
Corrective and preventive actions (CAPAs) are actions taken to address issues, such as nonconformances, and avoid similar ones from occurring.
Reviewing nonconformances and CAPA in quality management reviews is an essential part of continuous improvement and maintaining an effective QMS.
Monitoring and Measurement of Quality KPIs
Quality Key Performance Indicators (KPIs) are specific and relevant metrics that provide evidence of the performance of the QMS and progress toward a specific goal.
By tracking quality KPIs over time, Life Science companies can identify trends, areas for improvement, and the effectiveness of the quality system.
Effectiveness of Actions Taken To Address Risks and Opportunities
Tracking the effectiveness of actions taken to address risks and opportunities helps to ensure that the QMS is proactive and effective in managing risks and seizing opportunities.
Opportunities for Improvement
The opportunities for improvement are areas where the QMS can be improved to enhance its effectiveness and efficiency. The QMR should identify opportunities for improvement, such as streamlining processes, reducing waste, or improving customer service.
Audits Findings
The audit findings are the results of internal and external audits of the QMS. They provide independent and objective feedback on the effectiveness of the QMS.
Audit findings should be reviewed and addressed to ensure that the QMS meets its requirements and that any quality issues are corrected.
Applicable New or Revised Regulatory Requirements
Any new or revised regulations that impact the QMS should be reviewed to ensure that the QMS is compliant and that any necessary changes are made.
What Are the Quality Management Review Outputs?
Management review outputs are the results of the management review process. They are the decisions and actions that are taken to improve the effectiveness of the company’s quality management system.
The following are examples of management review outputs based on ISO 9001:2015, ISO 13485:2016, and ICH Q10.
Revisions to Quality Policy and Quality Objectives
Revisions to quality policies and objectives are updates to the company’s policies and objectives to ensure they remain aligned with its strategic goals and requirements.
Improvement of the Quality Management System
Improvement of the QMS includes all actions taken to enhance the effectiveness of the quality system in meeting its objectives and is continuously improving.
Improvement of Product Related to Customer Requirements
The improvement of products related to customers is the actions taken to ensure products meet or exceed customer expectations.
Allocation or Reallocation of Resources
Allocation or reallocation of resources in quality management refers to the decision-making process of determining how to assign or reassign financial, human, and other resources to support the QMS and its processes in being effective.
Personnel Training Needs
Personnel training needs are the gaps between the knowledge, skills, and abilities that personnel currently have and those that they need to perform their jobs effectively.
The QMR should identify training needs and help develop training programs to address the knowledge and skills gaps of personnel involved in the QMS.
Timely and Effective Communication of the Results
Communication of the results is the process of sharing the outcomes of the quality management review with relevant personnel in a timely and comprehensive way. This is important to ensure that all employees are aware of the results of the review and that any necessary actions are taken.
To improve the efficiency and effectiveness of quality management reviews, many Life Science companies are implementing QMS software solutions. Such solutions facilitate the planning, execution, and documentation of the quality management review processes, securing more consistent and reliable outcomes.
What Is the Role of QMS Software in Quality Management Reviews?
The role of QMS software in quality management review is to streamline the entire management review process, enabling companies to consistently assess and improve the quality management system effectively.
The QMS software provides a centralized platform to facilitate the systematic planning, execution, and documentation of management reviews, allowing real-time access to data for informed decision-making.
The software helps track and monitor key review inputs, such as audit findings, nonconformances and CAPAs, customer feedback, and process performance.
Automated reminders and notifications and easy access to quality KPI data improve visibility and accountability, making the review process more transparent and efficient.
SimplerQMS is a fully validated, according to GAMP 5, eQMS software solution for Life Sciences that simplifies quality management reviews.
The software provides several features that can be used to support management reviews, including creating and managing archives and projects related to documents, streamlining data collection, and generating quality KPI reports.
SimplerQMS helps Life Sciences companies comply with a variety of requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, EU GMP, and more.
The system provides comprehensive support for QMS processes, such as document management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.
To assess how an investment in an eQMS solution could benefit your company, download our eQMS Business Case template today.
With the template, you can learn more about the specific benefits that SimplerQMS can offer your business, such as potential efficiency gains, cost savings, and compliance improvements. By clearly and concisely presenting this information to management, you can build a strong case for implementing an eQMS.
Final Thoughts
A Quality Management Review (QMR) is a formal process for top management to assess the quality management system’s (QMS) effectiveness, suitability, and adequacy. The main purpose of QMR is to identify opportunities for improvement and ensure continuous suitability and alignment with the company’s strategic goals.
QMS software collects quality data from production processes, inspections, audits, customer feedback, and more, providing real-time access to information and improving evidence-based decision-making.
SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences that simplifies the management review process by providing a centralized platform for planning, execution, and documentation of management reviews.
Improve your quality management review process with SimplerQMS. Schedule a demo with our quality experts to learn how our software can streamline your QMS management.
