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Summary

Your Management Review SOP defines how your leadership team systematically evaluates QMS effectiveness, reviews quality objectives, and makes strategic decisions to ensure continuous improvement and regulatory compliance through structured annual assessments.

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Why is SOP Management Review important?

Management review exists because regulators require top management accountability for quality system effectiveness. It demonstrates that your leadership actively oversees quality performance rather than delegating it entirely to quality personnel. This process transforms quality management from a compliance exercise into a strategic business function that drives organizational improvement. The SOP ensures consistency in how management evaluates QMS performance, makes data-driven decisions about resource allocation, and responds to regulatory changes. It also provides auditors with evidence that your organization has systematic oversight mechanisms in place and that quality management receives appropriate executive attention.

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Regulatory Context

  • FDA
  • MDR
Under 21 CFR Part 820 (Quality System Regulation):
  • Management review is mandatory under Section 820.20(c)
  • Must include adequate resources and assignment of trained personnel
  • Review must cover QMS effectiveness and corrective actions
  • Top management must demonstrate commitment to quality system
Special attention required for:
  • Management responsibility documentation (820.20)
  • Integration with CAPA system (820.100)
  • Resource allocation decisions (820.20(a))
  • Quality system effectiveness metrics tracking

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Guide

Your Management Review SOP establishes the framework for systematic quality system evaluation. Design the process to provide meaningful insights rather than just completing a compliance checklist.

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Defining Key Performance Indicators (KPIs)

Establish measurable KPIs that align with your quality objectives and provide meaningful insights into QMS effectiveness. Include metrics for training completion, audit findings, customer complaints, CAPA closure rates, and regulatory compliance. Avoid metrics that are too numerous or difficult to track consistently. Set realistic acceptance criteria for each KPI. Not every metric needs to achieve 100% success - focus on trends and continuous improvement rather than perfection. Document the rationale for your acceptance criteria so auditors understand your approach.

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Input Data Collection

Systematically collect input data throughout the year rather than scrambling before the review. Assign responsibility for each data type to specific team members. Include feedback and complaints, audit results, monitoring data, CAPA status, regulatory changes, and improvement recommendations. Create a centralized system for tracking this information. Many organizations use spreadsheets or quality management software to maintain ongoing data collection. The key is consistency and completeness rather than sophisticated tools.

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Review Meeting Structure

Plan your management review meeting to be productive and decision-focused. Distribute input data in advance so participants can prepare. Structure the agenda around KPI review, trend analysis, problem identification, and action planning rather than just reading through data. Include all management team members with quality responsibilities. This typically includes C-level executives, quality managers, and functional area leaders. Document attendance and ensure decisions have appropriate authority backing.

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Decision Documentation and Follow-up

Document specific decisions and action items with assigned responsibilities and timelines. Avoid vague commitments like “improve training” - instead specify “implement quarterly training effectiveness assessments by Q3.” This provides clear direction and accountability. Establish a follow-up mechanism to track action item completion. Many organizations incorporate management review follow-up into quarterly business reviews or monthly quality meetings. The goal is ensuring decisions translate into actual improvements.

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Integration with Other QMS Processes

Connect management review outputs to other QMS processes. CAPA investigations may arise from review findings. Resource allocation decisions affect multiple processes. Quality objective updates impact performance monitoring throughout the organization. This integration demonstrates that management review is not an isolated activity but a central coordination mechanism for your quality system.

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Example

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Scenario

BioMed Innovations conducts their annual management review after completing internal audits and collecting customer feedback data. The CEO, VP of Quality, CTO, and VP of Operations evaluate QMS performance against predetermined KPIs, identify improvement opportunities, and set strategic direction for the upcoming year.

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Example Management Review Process

Pre-Review Data Collection:
  • Training completion rates: 98% (Target: 95%)
  • Internal audit findings: 2 minor nonconformities (Target: <5)
  • Customer complaints: 12 received, 11 resolved (Target: 95% resolution)
  • CAPA closure rate: 89% (Target: 90%)
  • Regulatory updates: 3 identified, all implemented within 6 months
Review Meeting Agenda:
  1. KPI Performance Review - Quality Manager presents dashboard
  2. Trend Analysis - Discussion of year-over-year improvements
  3. Problem Areas - Focus on CAPA closure rate shortfall
  4. Resource Needs - Request for additional training budget
  5. Regulatory Changes - Impact assessment of new FDA guidance
  6. Action Planning - Specific improvement initiatives for next year
Key Decisions:
  • Approve 20% increase in training budget for specialized courses
  • Implement monthly CAPA status reviews to improve closure rates
  • Assign VP of Operations to lead regulatory change assessment process
  • Update quality objectives to include customer satisfaction metrics
  • Schedule quarterly mini-reviews to monitor progress
Follow-up Actions:
  • Quality Manager to implement monthly CAPA reviews by March 15
  • VP of Operations to develop regulatory change procedure by April 30
  • CEO to approve budget allocation by February 28
  • All department heads to incorporate new objectives by January 31

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Q&A

Internal audits are required for ISO 13485 compliance and involve testing your team’s understanding of processes. Management reviews should be done annually, focusing on KPIs and quality performance. They are recommended before a conformity assessment but are not mandatory before product release. The SOP should integrate audit results as key input data.
Unofficial audit recommendations should be reviewed and considered for implementation. They don’t require a CAPA but can be managed through change management by updating documents to improve compliance. Include these recommendations in your management review input data for evaluation.
Include feedback and complaints, reporting to regulatory authorities, audit results, monitoring and measurement of processes and products, corrective and preventive actions, follow-up from previous reviews, changes affecting the QMS, improvement recommendations, and applicable new regulatory requirements.
Management review should be conducted at least annually, but more frequent reviews may be beneficial for rapidly growing organizations or those experiencing significant changes. The SOP should specify timing relative to other QMS activities like internal audits and regulatory deadlines.
The management team should include C-level executives and other key personnel responsible for quality-affecting work. This typically includes the management representative, functional area leaders, and anyone with authority to allocate resources or make strategic decisions affecting quality.
Management review outputs should be recorded according to your document control SOP and should address QMS improvement needs, product improvement related to customer requirements, responses to new regulatory requirements, and resource needs. Assign specific responsibilities and timelines for each action item.
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