How to Hold a Management Review

 

Includes a Free Downloadable Management Review Agenda Template for FDA and ISO 13485 Compliance

 

Conducting an effective management review is a foundational requirement under both FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016.

This article explains the regulatory expectations, outlines the required agenda topics and discussion points, and offers a free downloadable Management Review Agenda Template that includes valuable optional elements that support broader quality system oversight. These optional elements are particularly helpful because many ISO and FDA requirements call for planned, periodic reviews (e.g., validation, regulatory tracking, risk management, and supplier evaluations). Incorporating those into the management review can be an efficient way to ensure they are completed on schedule and documented without needing to create and manage entirely separate processes. This approach helps streamline compliance by centralizing documentation and reducing the risk of missed reviews. However, it’s not always appropriate: if a topic requires more than 10–15 minutes or involves detailed discussion (such as a full risk management update or a deep-dive into cybersecurity posture), it should be handled in a separate, focused meeting outside the scope of the management review. As always, use this article and template as a starting point and customize it to meet the needs of your organization.

Management Review Requirements: FDA vs. ISO 13485

FDA 21 CFR Part 820

Under 21 CFR 820.20(c), the FDA requires:

“Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals… The dates and results of quality system reviews shall be documented.”

That’s it. No agenda. No checklist. No guidance on what “suitability and effectiveness” look like.

ISO 13485:2016

ISO 13485 is more prescriptive. Clause 5.6 outlines:

• • Required inputs (5.6.2) – These define what must be discussed
  • Required outputs (5.6.3) – These define what must result from the review

This structure makes ISO 13485 a practical framework for companies who want to satisfy both requirements through a unified management review process.

Required Management Review Inputs

The downloadable template agenda reflects ISO-required inputs and is structured to meet FDA expectations as well, with built-in prompts and formatting to ensure documentation is clear, complete, and audit-ready. This list includes commentary on what type of information to include in each section – not all of it is expressly required, but including it will ensure a comprehensive management review. The optional, but encouraged items are noted in italics.

1. Follow-Up from Previous Reviews

• • Track completion of prior action items
  • Carry incomplete tasks forward to the current review’s output section

2. Quality Policy

• • Review the current quality policy
  • Document whether it remains suitable and relevant
  • Updates to whether organizational scope, product lines, or markets have changed

3. Quality Objectives

• • Review each objective’s measurable target and actual performance
  • Indicate whether the objective was met (e.g., “Process 100% of complaints within 15 days; actual = 98%; not met”)
  • Include discussion of trends or contributing factors
  • If objectives were not met, discuss follow-up actions

4. Feedback (Other Than Complaints)

• • Capture relevant input from surveys, field feedback, service reports, or internal users
  • Summarize key themes or concerns

5. Complaints

• • Report quantity, nature, and trends of complaints
  • Review response timeliness and resolution quality
  • Evaluate open and closed complaints for systemic issues

6. Reporting to Regulatory Authorities

• • Confirm whether any adverse events have been or should be reported (e.g., MDRs)
  • Review timeliness and completeness of required reports
  • Identify upcoming reporting deadlines (e.g., biennial safety reports)

7. Audits

• • Include dates, scope, and results of:
    • • Internal audits
      • External audits (e.g., ISO, MDSAP)
      • Regulatory inspections
      • Supplier/vendor audits
  • Summarize findings, trends, and closure of related actions

8. Monitoring and Measurement of Processes

• • Evaluate whether management reviews, audits, CAPAs, and complaint closures are occurring on schedule
  • Discuss process validation status and any failures or triggers for revalidation
  • Review software validation status (for QMS tools or other process-related software, not commercialized products)

9. Monitoring and Measurement of Product

• • Nonconformances; number and nature
  • Product failures and recalls
  • QC data and yield trends
  • Summarize any trends or lessons to be learned

10. CAPA Activity

• • Document number and nature of corrective and preventive actions
  • Evaluate trends, root causes, closure timelines, and effectiveness

11. Regulatory and Standards Updates

• • Include a current external document list
  • Identify any changes in applicable regulations or standards
  • Evaluate whether updates are required to procedures or controls

12. Changes That Could Affect the QMS

• • Discuss recent or upcoming changes such as:
    • • New product launches
      • Expansion into new markets
      • Organizational restructuring
      • Facility relocations
      • Key personnel turnover

13. Recommendations for Improvement

• • Capture suggestions for process improvement, QMS streamlining, or new metrics

Required Management Review Outputs

Each agenda includes a Review Output section where the following questions are answered and justified:

• • Is the Quality Policy suitable?
  • Are the Quality Objectives suitable?
  • Is the Quality Management System suitable and effective?
  • Are changes needed to the QMS, product, or processes?
  • Are resource needs adequate and appropriate?
  • Are there any actions required to meet new or revised regulatory requirements?
  • Were risk management implications considered during the review?

This output section provides clear, auditable answers supported by documentation from the input section.

Optional Topics to Consider

Although not required by ISO 13485, the templates offer optional agenda items that are often useful for comprehensive QMS oversight. These may be especially valuable when integrated into the management review as a central checkpoint for long-cycle tasks.

Organizations should tailor inclusion of these items based on size, risk level, and scope of operations.

Optional Agenda Topics

• • Regulatory Calendar Tracking
    
    • • Required post-market report due dates
      • Training and/or recertification intervals
      • Cumulative regulatory change reviews since last 510(k)
      • Cybersecurity reviews
      • Risk review
  • Training Effectiveness
    • • Competency review for non-production employees
      • Metrics on whether training reduces errors, NCRs, or audit findings
  • Supplier Evaluations
    • • Review timing and outcomes of supplier re-evaluations
      • Summarize disqualifications, risk ratings, or conditional approvals
  • External Standards Review
    • • Document the list of controlled standards
      • Confirm they are current and relevant
  • Software Validation (QMS Software)
    • • Track validation status for software like document control systems, complaint tracking tools, or calibration programs
      • Note any upcoming revalidations or failure events

These elements are not one-size-fits-all, but may offer an efficient way to manage documentation and accountability for tasks that otherwise fall outside routine reviews.

 

Download the Template

To support both compliance and operational efficiency, download the fully customizable Management Review Agenda and Minutes Template. This tool:

• • Meets ISO 13485:2016 requirements for inputs and outputs
  • Addresses 21 CFR 820 expectations for management oversight
  • Suitable for the upcoming QMSR requirements from FDA
  • Includes space for additional items relevant to your QMS and business goals
  • Provides example phrasing and formatting to support ease of use

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Download the Management Review Agenda Template Now