Quality Management Review (QMR): Definition, How to Conduct, SOP, and Requirements

A Quality Management Review (QMR) is a formal, documented evaluation of an organization’s Quality Management System (QMS) conducted at planned intervals. The purpose of the QMR is to ensure that the QMS remains suitable, adequate, and effective. The QMR ensures that the QMS complies with regulatory requirements and supports continual improvement across business and quality operations.

To conduct an effective QMR, organizations must collect and analyze objective data such as audit results, CAPA status, customer feedback, process performance, resource adequacy, and any agreed follow-up actions. QMR effectiveness is evaluated through measurable outcomes like CAPA closure rates, improvement trends, verified risk reduction, and other outcomes.

A QMR includes supporting documents, review inputs, and review outputs. Inputs comprise audit results, complaint data, performance indicators, and regulatory updates. Outputs include improvement actions, resource decisions, and documented evidence of quality system effectiveness.

A QMR Standard Operating Procedure (SOP) defines the process for planning, conducting, documenting, and following up on management reviews. A QMR SOP includes purpose and scope, defined roles and responsibilities, review frequency, data requirements, reporting format, and record retention instructions.

QMR requirements are outlined in standards and regulations such as ISO 9001:2015 (Clause 9.3), ISO 13485:2016 (Clause 5.6), FDA 21 CFR Part 820.20(c), and ICH Q10 (Sections 2.6 and 4.1). As per QMR requirements, top management must periodically review QMS performance and maintain documented evidence of QMS effectiveness and continual improvement.

SimplerQMS streamlines QMR processes by automating data collection, task tracking, and documentation control. SimplerQMS provides real-time dashboards for reviewing QMS performance, maintains electronic records with audit trails and electronic signatures compliant with FDA 21 CFR Part 11, and EU Annex 11. It enables management to track actions, verify effectiveness, and demonstrate accountability through data-driven reviews.

What Is a Quality Management Review (QMR)?

A Quality Management Review (QMR) is a formal, documented assessment conducted at defined intervals to evaluate the performance, suitability, and effectiveness of a Quality Management System (QMS). A QMR ensures that the QMS continues to meet regulatory, customer, and business requirements while driving continual improvement.

QMR requirements are established across key international standards and regulations, including ISO 9001, ISO 13485, ICH Q10, and FDA 21 CFR Part 820. These standards and regulations require top management to periodically review the effectiveness, adequacy, and regulatory compliance of the QMS. QMS effectiveness is assessed using objective evidence such as audit results, CAPA data, and performance metrics.

The primary purpose of a QMR is to provide top management with data-driven insight into the performance of the QMS and its processes, confirming compliance and driving continuous improvement.

Executive or Top Management responsible for the QMS conducts the QMR. QMR participants typically include Quality Assurance and Regulatory Affairs leadership, functional process owners such as R&D, engineering, or manufacturing, as well as the Management Representative or Quality Management Review Coordinator.

QMR inputs include audit results, customer and complaint feedback, process and product performance data, CAPA status, post-market and vigilance information, regulatory changes, resource adequacy, and progress toward quality objectives. QMR outputs document required QMS improvements, updated objectives or policies, resource or training needs, process or product optimization measures, and assigned follow-up responsibilities.

Why Is a QMR Needed?

A QMR is needed to ensure the QMS remains effective, compliant, and aligned with business and regulatory objectives. A QMR allows executive management to assess quality data, identify issues, allocate resources, and drive continual improvement across the organization.

The purpose of the QMR is to ensure top management oversight, verify the adequacy of quality processes, and demonstrate compliance during audits and inspections. Regular management reviews ensure organizations have visibility over QMS performance and compliance with applicable regulatory requirements.

The key reasons why QMRs are essential for life science manufacturers are outlined below.

• Regulatory Compliance: Management reviews are required by ISO 13485, ISO 9001, 21 CFR Part 820, and ICH Q10, among other standards and regulations. Management reviews provide documented proof that top management evaluates QMS effectiveness and makes decisions based on quality performance data.
• QMS Suitability and Effectiveness: QMRs confirm whether the QMS continues to meet regulatory, customer, and internal requirements. Management uses QMR data to ensure that documented processes and procedures function as intended.
• Data-Driven Decision-Making: QMRs consolidate information from audits, CAPAs, complaints, and performance indicators. QMR outcomes allow management to make evidence-based decisions on resource needs, improvement priorities, and risk control actions.
• Continual Improvement: QMRs identify opportunities to improve QMS process performance and product quality through review of trend data, recurring issues, corrective actions, and preventive actions.
• Risk Control and Product Safety: Management can review risk management data, including risks identified from post-market feedback. This review ensures product quality and safety are maintained and that residual risks remain acceptable.
• Management Responsibility and Commitment: A QMR shows active leadership engagement in quality oversight, QMS effectiveness, and regulatory compliance.
• Alignment of Quality Objectives With Business Strategy: Management reviews connect quality metrics with strategic goals, ensuring that QMS performance supports operational efficiency, compliance, and customer satisfaction.
• Regulatory Audits and Inspections: A well-documented QMR provides clear evidence of management oversight and continuous improvement of quality system performance. QMR provides information on focus areas for internal audits, which serves as input for regulatory audit preparation.

What Is the Relationship Between QMR and QMS?

The QMR provides top management with a structured method to evaluate the QMS’s suitability, adequacy, and effectiveness.

The QMR verifies that QMS processes function as intended and comply with regulatory requirements such as ISO 13485, FDA 21 CFR Part 820, and ICH Q10, among other regulations and standards.

The QMR consolidates key QMS inputs such as audit results, CAPAs, complaints, and performance metrics to enable data-driven decisions and continual improvement. The QMR ensures that management oversight is documented, proactive, and aligned with quality and business objectives. The QMR serves as the control point that ensures the QMS remains compliant, effective, and that areas of continuous improvement are identified.

How to Conduct a Quality Management Review?

To conduct a Quality Management Review, organizations gather and analyze key input data such as audit results, customer feedback, and quality performance metrics. Management then reviews this information in a structured meeting to evaluate QMS effectiveness, make informed decisions, and assign actions for improvement, which are documented and followed up on in subsequent reviews.

The QMR process follows 6 defined stages to ensure the review is planned, data-driven, and results in measurable outcomes that improve system effectiveness and compliance.

The 6 key steps in conducting a QMR are listed below.

1. Preparation and Planning: In the preparation and planning step, define the scope, objectives, and agenda of the QMR. Identify participants and schedule the review at a frequency defined in the QMS procedure.
2. Data Collection and Analysis: In the data collection and analysis step, compile and analyze QMS performance data. Gather inputs such as audit results, CAPA data, customer feedback, process and product performance metrics, and regulatory updates. Evaluate trends, key performance indicators (KPIs), nonconformance rates, complaint patterns, and audit findings to determine the overall state of quality performance.
3. Conducting the Review Meeting: In the review meeting step, hold the QMR meeting with top management and relevant process owners. Present summarized data, discuss identified risks, assess resource adequacy, and review progress against quality objectives. Ensure discussions are factual, traceable, and outcome-oriented.
4. Identifying Action Items and Follow-Up: In the identification of action items and follow-up step, document decisions and improvement actions agreed upon during the meeting. Assign responsibilities, define completion timelines, and record follow-up requirements for verification during the next review cycle.
5. Documentation and Reporting: In the documentation and reporting step, prepare a formal QMR report summarizing key inputs, decisions, and outputs. Ensure all supporting records, such as meeting minutes, data summaries, and action trackers, are controlled and maintained as part of QMS documentation.
6. Implementation of Improvement Actions: In the implementation of improvement actions stage, execute approved actions such as process updates, resource allocations, or policy revisions. Monitor and verify completion and effectiveness through CAPA, change control, and ongoing management oversight.

What Is Included in a QMR?

A QMR includes all documented evidence needed to evaluate QMS performance. QMR documentation consists of supporting documents, review inputs, and review outputs. Inputs define the review agenda. Supporting documents provide the objective evidence for evaluation. Outputs document the decisions, actions, and improvements required to ensure ongoing compliance and product quality. These records form the basis of the QMR report, which summarizes management’s evaluation, decisions, and follow-up actions.

A QMR report typically includes concise summaries of each review input, with full supporting documents referenced in the QMS. The summaries present the essential information required for management decisions. Referencing the source records ensures traceability, while keeping the QMR report concise and easy to review.

Typical inputs reviewed during a QMR are listed below.

• Audit results and findings
• Nonconformances, deviations, and any ongoing investigations
• Management review action items and change control activities
• Customer feedback and complaint trends
• Product and process performance data
• CAPA status and effectiveness data
• Resource adequacy and training status
• Performance against quality objectives and targets
• Updates to regulatory requirements or standards

Risk management updates, supplier performance data, and supporting documents included in a QMR are listed below.

• Previous QMR reports and meeting minutes
• Internal and external audit reports
• CAPA records
• Nonconformance reports
• Customer complaint logs
• KPI and process performance reports
• Management review checklist with applicable clauses from the required regulation or standard
• Risk assessment summaries (risk management reports, FMEA, risk registers)
• Post-market surveillance data
• Regulatory updates and corresponding QMS updates or change summaries.
• Change control summary reports
• Training records and resource plans
• QMR meeting agenda and attendance list

Outputs that should result from a QMR are listed below.

• Updated quality objectives and policies
• Identified improvement actions or risk mitigation strategies
• Decisions for resource allocation
• Process and system updates
• Assigned responsibilities and timelines
• Management follow-up and verification plans
• Communication of results to relevant functions
• Updated or approved QMR report

Supporting Documents

Supporting documents are the factual and traceable evidence required for management to evaluate QMS performance. Supporting documents substantiate the information presented in a QMR, such as quality data and trends presented during the QMR. A QMR report includes concise summaries of each review input. The full underlying documents are referenced within the QMS. The summaries present the essential information required for management decisions. Referencing the source records ensures traceability, while keeping the QMR report concise and easy to review.

Key items typically included as supporting documents are listed below.

• Audit Reports and Findings Summaries: Audit reports provide evidence of system compliance and highlight areas requiring corrective or preventive actions. Audit reports verify the effectiveness of QMS processes and the implementation of prior improvement efforts.
• CAPA and Nonconformance Records: CAPA and nonconformance records demonstrate how quality issues are identified, investigated, and resolved. CAPA records provide evidence that root causes are addressed in a timely manner and effectiveness is verified.
• Customer Complaints and Feedback: Customer complaints capture product and service performance from the user perspective. Customer complaints and feedback data support the identification of recurring issues and improvement opportunities.
• Process Performance Metrics and KPIs: Process performance metrics quantify operational efficiency and product quality. Trends and deviations guide data-driven decisions during the review.
• Risk Management Reviews and Updates: Reflect ongoing identification, evaluation, and control of quality and safety risks. Risk management documentation must also be reviewed to ensure that risk management is integrated into QMS processes.
• Resource and Training Records: Confirm that personnel are qualified and resources remain adequate to maintain QMS performance. Training gaps must trigger targeted training or resourcing actions.
• Regulatory Updates and Change Logs: Record new or revised regulations, standards, or guidance documents to ensure that the QMS remains aligned with current regulatory requirements.

Supporting documents are typically prepared by process owners and reviewed by QA prior to the QMR. Supporting documents are maintained as controlled records under document control and retained per the organization’s record retention schedule. A few requirements that apply for the preparation and maintenance of supporting documentation include the ISO 13485:2016, Clause 4.2.5, ISO 9001:2015, Clause 7.5.3. and other equivalent quality management standards.

Supporting documents ensure traceability of all QMR data, support audit readiness, and provide verifiable proof of QMS performance.

Review Inputs

Review inputs are the data and information evaluated during the QMR to assess the suitability, adequacy, and effectiveness of the QMS. Review inputs provide management with objective evidence to confirm system performance, identify risks, and determine opportunities for improvement.

Key items that typically constitute review inputs are listed below.

• Audit Results (Internal, Supplier, and External): Audit results present verified findings that indicate the level of process and system compliance. Audit results serve as a key performance indicator for QMS maturity.
• Customer Satisfaction and Complaint Trends: Customer satisfaction and complaint trends provide insight into external product performance, service quality, and emerging issues that require investigation or improvement actions.
• Product and Process Conformity Data: Product and process conformity data summarize key metrics such as yield rates, deviations, and defect levels. This data demonstrates consistency in product quality and process control effectiveness.
• CAPA Action Status: CAPA status includes closure rates, overdue items, and effectiveness checks, and verifies that systemic issues are being addressed and controlled.
• Changes Affecting the QMS: Changes affecting the QMS include organizational, process, or regulatory changes that could influence quality system performance. These changes are reviewed to assess QMS impact and required updates.
• Quality Objectives and their Achievement Status: Compare defined targets for fulfilling quality objectives against actual QMS performance. Variances guide the setting of new goals and improvement priorities.
• Resource Adequacy and Training Needs: Resource adequacy evaluates whether staffing levels and competencies meet operational requirements. Identified resource or training gaps support training and workforce planning.
• Post-Market Feedback and Risk Analysis Updates: Combine real-world data from post-market surveillance activities with existing risk assessments to ensure continued product safety and regulatory compliance.

Review inputs are collected and presented by functional or process owners and verified for completeness by QA prior to the QMR. Review inputs are compiled and referenced in the QMR report and archived as part of management review records. Applicable standards and guidelines that define requirements for review inputs include ISO 13485:2016, Clause 5.6.2, and ICH Q10, Section 4.1.

Review inputs to ensure that QMR discussions are evidence-based, data-driven, and aligned with the organization’s quality and compliance objectives.

Review Outputs

Review outputs are the decisions, conclusions, and actions agreed upon during the QMR to maintain or improve the QMS. Review outputs document how management evaluates system performance and ensures accountability for implementing improvements.

Key items that typically constitute review outputs are listed below.

• Actions for QMS Improvement: QMS improvement actions define measurable steps to improve process efficiency, product quality, or compliance. Each action includes accountability and defined timelines for verification of completion and effectiveness.
• Updates to Quality Objectives and Policies: Updates to quality objectives and policies reflect revised priorities based on performance and regulatory expectations. Updates to quality policy and objectives align quality goals with organizational strategy.
• Resource Allocation Decisions: Resource allocation decisions confirm that the management ensures the provision of adequate personnel, infrastructure, and tools to meet QMS objectives.
• Process and System Modifications: Process and system modifications document approved changes to improve quality system control or reduce risk. Such modifications are tracked through change management.
• Follow-up Assignments and Timelines: Follow-up assignments and timeline outline responsibilities and due dates for implementation of actions. Timely follow-up ensures accountability and closure verification.
• Communication of QMR Results: Communication of QMR results ensures that review outcomes are shared with relevant teams to ensure organizational alignment and promotes transparency.

Review outputs are approved by top management and tracked by QA or the management representative to verify completion. Review outputs are summarized in the QMR report, which serves as the official record of management review outcomes. Requirements that apply for documenting review outputs include ISO 13485:2016, Clause 5.6.3, and ICH Q10, Section 4.3.

Review outputs demonstrate management accountability, verify follow-up implementation, and provide traceable evidence of continual QMS improvement.

How to Evaluate QMS Effectiveness After a QMR?

QMS effectiveness refers to the ability of the quality management system to meet quality objectives, fulfill regulatory or customer requirements, and support continual improvement.

To evaluate QMS effectiveness after a QMR, management should verify that actions identified during the review are implemented, measurable, and result in improved performance or compliance. Evaluation of QMS effectiveness focuses on data-driven evidence that the QMS continues to function as intended and achieves its objectives.

The main indicators used to measure the effectiveness of the QMS after a QMR are listed below.

• Closure and Verification of QMR Action Items: Closure of QMR Actions confirms that all improvement actions, CAPAs, and resource decisions from the QMR are completed, documented, and verified for effectiveness.
• Achievement of Quality Objectives: Achievement of quality objectives involves comparing actual performance against established quality goals and KPIs to determine whether planned improvements have been realized.
• Audit and Inspection Outcomes: Audit and inspection outcomes are assessed to identify trends in internal and external findings, including reductions in the recurrence or severity of nonconformances.
• CAPA Effectiveness: CAPA effectiveness is evaluated to confirm that implemented actions have addressed root causes, resulted in measurable quality improvements, and prevented recurrence across related processes or products.
• Process and Product Performance Metrics: Process and product performance metrics, such as defect rates, on-time delivery, and yield performance, are reviewed. Trends are analyzed to verify process stability, product consistency, and ongoing compliance with defined specifications.
• Customer Feedback and Complaint Trends: Customer feedback and complaint trends are analyzed to confirm that effective processes exist for capturing, evaluating, and trending customer feedback and complaints. Complaint investigations should verify that appropriate corrective actions are implemented to prevent recurrence and enhance product or service quality.
• Training and Resource Adequacy: Training and resource adequacy are verified to ensure that competence levels, staffing, and resources meet operational and compliance requirements. Improvement in training completion and performance metrics further supports these adequacy requirements.
• Risk Register Status & Mitigation Effectiveness: Risk register status assesses how proactively risks are identified, assessed, prioritized, and controlled. This includes verification of residual risk acceptability and effectiveness of mitigation measures.
• Supplier Quality Performance: Supplier quality performance is evaluated during the management review using risk-based metrics aligned with supplier classification and criticality. Key indicators assessed in the QMR include incoming defect rates, on-time delivery, and the effectiveness of supplier corrective actions.

How Often Should a Quality System Undergo Management Review?

The frequency of conducting QMRs should be defined in the organization’s QMS procedures and determined based on the complexity, scale, and regulatory environment of its operations.

Standards and guidelines such as ISO 9001, ISO 13485, and ICH Q10 require management reviews to be performed at planned intervals, typically at least once per year, or more frequently when significant quality events or changes occur. Performing management reviews at planned intervals ensures management oversight remains current and capable of addressing quality and compliance risks in a timely manner.

The factors that determine how often a QMR should be performed are listed below.

• Regulatory and Standard Requirements: Standards and guidelines such as ISO 9001, ISO 13485, and ICH Q10 require QMRs at planned intervals to demonstrate management oversight and continual improvement. In practice, regulated organizations typically perform reviews annually or semi-annually.
• Business and Operational Complexity: The higher the business and operational complexity, the more frequently QMRs should be conducted. Companies operating across multiple sites, regions, or product lines benefit from more frequent reviews to ensure consistent process control, identify systemic issues, and maintain alignment between QMS performance and organizational quality objectives.
• Quality and Compliance Risk Level: The higher the quality and compliance risk level, the greater the need for frequent QMRs. A high volume of nonconformances, CAPAs, or recurring complaints may necessitate quarterly or event-driven reviews, allowing management to monitor risk trends closely and verify the effectiveness of corrective measures.
• Process and Product Change Activity: Frequent process and product changes increase the need for additional QMRs. Regular reviews help verify that updates to design, manufacturing, or procedures are properly controlled, documented, and assessed to maintain product quality and regulatory compliance.
• Audit and Inspection Findings: Significant audit and inspection findings should trigger unscheduled management reviews. Early review of major or critical findings enables timely evaluation of corrective actions and helps prevent recurrence in related areas.
• Post-Market or Customer Feedback Trends: Increasing post-market or customer feedback issues indicate a need for earlier or more frequent QMRs. Reviewing complaint data, field failures, and satisfaction trends allows management to detect and address emerging product or process risks promptly.
• Organizational Growth or Structural Changes: Organizational growth and structural changes often necessitate additional QMRs. Reviews conducted during mergers, expansions, or leadership transitions help ensure quality governance, resource adequacy, and process continuity are maintained.
• Reviews Based on Quality Metrics: Reviews based on live quality metrics allow organizations to adjust QMR frequency dynamically. Companies using digital QMS platforms may conduct continuous or rolling reviews supported by real-time data, complemented by formal periodic reviews to consolidate and assess overall QMS performance.

What Is the Standard Operating Procedure for QMR?

A Standard Operating Procedure (SOP) for the QMR defines the formal process by which management reviews are planned, conducted, documented, and followed up. A QMR SOP’s primary function is to ensure a consistent, traceable, and compliant approach to evaluating QMS performance and driving continuous improvement across all quality processes.

The QMR SOP outlines responsibilities, review frequency, required inputs and outputs, and documentation controls. It ensures each review is performed according to regulatory and organizational requirements.

The core components included in a QMR SOP are listed below.

• Purpose and Scope: Purpose and scope describe the objective of the QMR procedure and define which parts of the QMS and organizational functions the QMR covers. The scope ensures that the review process remains comprehensive and aligned with organizational quality objectives.
• Roles and Responsibilities: Roles and responsibilities specify who prepares, reviews, and approves QMR-related data and documentation. QMR roles and responsibilities are held by top management, QA and RA leadership, process owners, and the management representative.
• Frequency and Planning Information: Frequency and planning define how often QMRs are conducted and the criteria for scheduling additional reviews. QMR planning includes planning of the agenda, required inputs, and attendees.
• QMR Inputs and Data Sources: QMR inputs and data sources list the required information for evaluation, such as audit results, CAPA status, complaint data, quality metrics, and resource adequacy.
• Meeting Process: The meeting process describes how meetings are conducted, including presentation of key data, discussion of risks, and decision-making protocols.
• Outputs and Action Tracking: Outputs and action tracking define how decisions, improvement actions, and resource allocations are documented and monitored to closure. Establishes measurable criteria and timelines for verifying action effectiveness.
• Documentation and Records: Documentation and records include QMR reports, attendance records, and supporting data, including information on document control and retention. Document control must ensure regulatory and internal retention requirements are met for traceability and audit purposes.
• Applicable Standards and Regulations: Standards and regulations include all applicable regulatory clauses maintained in a documented list. A standard and regulations checklist ensures effective verification of the QMS with applicable regulatory requirements.

Who Is Responsible for Conducting the QMR?

The responsibility for conducting a QMR lies primarily with top management, supported by QA, RA, and other functional process owners. Each role has defined accountability to ensure the QMR is planned, executed, and documented in compliance with QMS and regulatory requirements.

QMR execution follows a hierarchical structure where top management provides oversight and decision-making authority, while QA and process owners prepare and present performance data for evaluation.

The hierarchical structure of responsibility during QMR execution is listed below.

1. Top Management: Top Management holds ultimate accountability for the QMS and leads the QMR process. It reviews system performance, approves improvement actions, allocates resources, and ensures that QMR decisions align with strategic goals and quality objectives.
2. Quality Assurance (QA) or Quality Management Representative: The Quality Assurance or Quality Management Representative coordinates QMR planning, scheduling, and documentation. This role ensures data integrity, compiles inputs from all departments, maintains QMR records, and monitors follow-up actions to closure.
3. Functional and Process Owners: Functional and process owners provide input data from their respective operational areas, such as production, design, supply chain, or post-market activities. They present performance metrics, audit results, and CAPA status relevant to their processes to support data-driven management review.
4. Regulatory Affairs Representative (if applicable): The Regulatory Affairs representative advises management on regulatory changes and compliance risks that may impact the QMS. This role ensures that QMR decisions remain aligned with current regulatory expectations and applicable standards.
5. Risk Management or Compliance Lead: The risk management or compliance lead analyzes and presents risk-related data that influences product or process risk control. This individual supports the integration of risk management outcomes into QMR decision-making and improvement planning.
6. Document Control or Quality Systems Administrator: The document control or quality systems administrator maintains and archives QMR documentation, including meeting minutes, reports, and action trackers. This role verifies document version control and ensures that record retention complies with QMS and regulatory requirements.
7. Executive Secretary or QMR Coordinator (optional): The executive secretary or QMR coordinator assists with meeting logistics, coordination, and communication of QMR outcomes. This position ensures that review summaries, decisions, and approved actions are accurately documented and distributed to relevant stakeholders.

What Are the Requirements for QMR?

Different standards, guidelines, and regulations, such as ISO 9001:2015, ICH Q10, and 21 CFR Part 820, define requirements for conducting a QMR. As per these requirements, organizations must evaluate the continuing suitability, adequacy, and effectiveness of their QMS at defined intervals and document management review outcomes. QMRs are essential for demonstrating management accountability, regulatory compliance, and continual improvement.

Key regulations, standards, and guidelines referencing the QMR are listed below.

• ISO 9001:2015: Clause 9.3 Management Review of ISO 9001:2015 requires top management to review the QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the organization’s strategic direction.
• ISO 13485:2016: Clause 5.6 Management Review of ISO 13485:2016 requires documented reviews of the QMS by top management at planned intervals to assess system performance, identify changes needed, and ensure ongoing compliance with regulatory requirements.
• FDA 21 CFR Part 820: 21 CFR Part 820.20(c) Management Review requires management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency. The purpose is to ensure the quality system meets regulatory requirements and the manufacturer’s quality policy and objectives.
• ICH Q10: Section 4.1, management of ICH Q10 requires a formal process for reviewing the pharmaceutical quality system on a periodic basis. The management review must evaluate the achievement of Pharmaceutical Quality System (PQS) objectives and assess performance indicators used to monitor system effectiveness.

ISO 9001:2015

ISO 9001:2015 is an international standard for quality management systems applicable to any industry. The standard promotes a process-based approach, customer focus, risk-based thinking, and continual improvement. ISO 9001 requires management reviews at planned intervals to verify that the QMS remains suitable, adequate, effective, and aligned with the organization’s strategic direction.

Required management review inputs under ISO 9001:2015 include audit results, customer satisfaction and feedback, the extent to which quality objectives have been met, process and product performance, nonconformities and corrective actions, the status of previous actions, changes affecting the QMS, and the performance of external providers. ISO 9001 also requires reviewing the adequacy of resources and the effectiveness of actions taken to address risks and opportunities, as well as identifying opportunities for improvement.

Management review outputs must include decisions and actions related to improving the QMS and its processes, improving products and services, and addressing resource needs. Organizations may also identify additional improvement initiatives or updates to quality objectives based on review findings.

ISO 13485:2016

ISO 13485:2016 specifies QMS requirements for medical device organizations across the full product lifecycle, including design, production, distribution, installation, and servicing. The standard requires management reviews at planned intervals to confirm the continuing suitability, adequacy, and effectiveness of the QMS and its compliance with regulatory requirements.

Management review inputs required under ISO 13485:2016 include audit results, customer feedback, process and product performance data, the status of corrective and preventive actions, follow-up from previous reviews, changes that may affect the QMS, and recommendations for improvement. Organizations may also review post-market data, risk file updates, regulatory changes, and resource needs where relevant to performance and compliance.

Typical outputs of a management review include decisions and actions to improve the QMS and its processes, improve product performance, and address regulatory updates or resource needs. Additional outputs such as training actions, documentation updates, or process optimization measures may be included based on organizational requirements.

FDA 21 CFR Part 820

The FDA 21 CFR Part 820 Quality System Regulation (QSR) establishes current good manufacturing practice (cGMP) requirements for medical device manufacturers in the United States. As per 21 CFR Part 820.20(c), Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency per procedures. The dates and results of management reviews must be documented.

Although FDA 21 CFR Part 820 does not explicitly list required inputs and outputs for management review, manufacturers may adopt ISO 13485 inputs and outputs to ensure reviews are structured, auditable, and comprehensive.

ICH Q10

The International Council for Harmonization (ICH) developed ICH Q10 as a model for a (PQS) covering the product lifecycle from development through commercial manufacturing and discontinuation. ICH Q10 is a guideline that complements GMP requirements and provides a framework for managing pharmaceutical product quality and continual improvement.

Section 4.1 of ICH Q10 requires management to periodically review the performance of the PQS. The management review should evaluate whether quality objectives are being achieved, whether the system remains effective, and whether opportunities for improvement have been identified.

Management review inputs under ICH Q10 include information on process performance and product quality, including outsourced activities, the effectiveness of CAPA and change management, the outcome of internal and external audits and inspections, and feedback from complaints and regulatory authorities. These inputs identify trends or risks that may affect product quality.

Typical outputs of a management review under ICH Q10 include actions to improve the PQS, actions to enhance product quality, decisions on resource needs, and prioritized continual improvement initiatives. The results of the review should be documented and followed up on to ensure that agreed actions are implemented and verified for effectiveness.

What Is the Role of QMS Software in Quality Management Reviews?

The primary role of QMS software in the QMR is to centralize, streamline, and document the review process. QMS software enables management to access up-to-date quality data, track performance metrics, and maintain traceable evidence of decisions and actions.

The primary purpose of QMS software in QMR is to provide a single system for collecting, analyzing, and reporting QMS performance data. QMS software supports the review of audit results, CAPA effectiveness, customer complaints, and other inputs while ensuring that management review records meet regulatory and documentation control requirements.

The key functions of QMS software that support QMR activities are listed below.

• Data Collection and Reporting: Consolidates data from CAPA, audits, complaints, and training modules into dashboards and trend charts for review.
• Document and Record Control: Ensures all QMR inputs, outputs, and meeting minutes are version-controlled, approved, and retrievable for audits.
• Task Assignment and Tracking: Automates assignment of management review actions with due dates and electronic verification of completion.
• Performance Metrics and KPIs: Generates real-time QMS performance indicators such as CAPA closure rate, complaint trends, or audit finding statistics.
• Change and Risk Management Integration: Links QMR findings to related change requests and risk assessments, ensuring identified issues are evaluated for impact and updates to processes, documentation, and risk controls are made when needed. 
• Audit Trail and Compliance Traceability: Maintains complete traceability of QMR data, approvals, and signatures in accordance with 21 CFR Part 11 and EU Annex 11.

QMS software helps ensure that management reviews are performed on time, with complete data, and in compliance with regulatory requirements. QMS software also reduces manual errors and automates reminders for reviews or training.

By centralizing QMR data, QMS software gives visibility into key performance metrics such as CAPA closure rates, audit finding trends, complaint frequency, and on-time training completion, allowing efficient monitoring of quality system activities. Centralized QMR data also supports risk-based decisions, helping prioritize actions based on severity or compliance impact, such as supplier quality risks or recurring deviations. Management accountability is demonstrated through records of assigned responsibilities, action tracking, and timelines for completion of actions identified in the QMR.

SimplerQMS is a QMS software that supports a wide range of interconnected quality processes, including audit management, CAPA, nonconformance handling, change control, document management, training, supplier management, complaint handling, and others within a single validated system.

SimplerQMS supports QMR compliance by maintaining electronic records with complete audit trails and electronic signatures in accordance with FDA 21 CFR Part 11, and EU Annex 11 requirements. SimplerQMS helps ensure that management review records are complete, traceable, and compliant with applicable regulatory requirements. It also helps organizations maintain an effective QMS and drive continuous improvement through data-driven management reviews.