- Owner
- Quality Manager
- Effective date
- September 15, 2026
- Review cycle
- Every 12 months
1.Purpose
To make sure top management periodically reviews the performance of the quality management system, decides on needed changes, resources and improvement actions, and that decisions are tracked to completion.
2.Scope
Applies to planning, gathering inputs for, running and following up on scheduled management review meetings. Execution of individual CAPAs and audits is covered by their own SOPs; this SOP covers reviewing their combined results.
Definitions
- Management review
- A scheduled meeting where top management evaluates quality system performance and decides on changes.
- Input
- A standard agenda item, such as audit results or complaint trends, that feeds the review.
- Action item
- A decision from the review assigned to a named owner with a due date.
- Quality objective
- A measurable target the organization has set for quality performance.
3.Responsibilities
- Quality Manager
- Schedules the review, compiles inputs, and tracks action items to completion.
- Executive Sponsor
- Leads decision-making on changes, resources and improvement priorities.
- Process Owner
- Presents performance data for their area against quality objectives.
- Document Controller
- Records minutes, distributes them, and archives review inputs.
RACI matrix
| Activity | Quality Manager | Executive Sponsor | Process Owner | Document Controller |
|---|---|---|---|---|
| Schedule the review and compile inputs | R/A | I | C | I |
| Present performance against objectives | C | I | R/A | - |
| Decide on changes and resources | C | R/A | C | - |
| Record and distribute minutes and actions | C | I | I | R/A |
| Track action items to completion | R/A | I | C | I |
R = Responsible, A = Accountable, C = Consulted, I = Informed
4.Materials and PPE
Materials, tools and systems
- →Management review agenda and input template
- →Meeting minutes template
- →Action item tracker
- →Quality objective performance data
5.Procedure
- 5.1
Schedule the review meeting
Quality ManagerThe Quality Manager schedules the management review meeting according to the defined review cycle and invites the required attendees.
- 5.2
Compile the inputs
Quality ManagerThe Quality Manager compiles the standard inputs, including audit results, CAPA status, complaint trends, quality objective performance, and the status of prior action items.
Checkpoint: Every standard input area appears in the compiled package; none are skipped for the sake of time.
- 5.3
Distribute the pre-read
Quality ManagerThe Quality Manager distributes the compiled input package to attendees ahead of the meeting so they arrive prepared.
- 5.4
Present each input area
Process OwnerThe Process Owner presents performance in their area against the relevant quality objectives during the meeting.
- 5.5
Discuss risks and opportunities
Executive SponsorThe Executive Sponsor leads a discussion of risks, resource needs and opportunities for improvement raised by the inputs.
- 5.6
Decide on changes
Executive SponsorThe Executive Sponsor decides on needed changes to the quality management system, processes or resources based on the discussion.
Checkpoint: Each decision made in the meeting has a named owner and a due date before the meeting ends.
- 5.7
Record decisions and action items
Document ControllerThe Document Controller records the decisions, action items and owners from the meeting in the minutes.
- 5.8
Distribute approved minutes
Document ControllerThe Document Controller distributes the approved minutes and action items to attendees and relevant process owners.
- 5.9
Track action items
Quality ManagerThe Quality Manager tracks each action item to completion between review cycles using the action item tracker.
Warning: An action item without a tracked due date tends to never get closed.
- 5.10
Escalate overdue items
Quality ManagerThe Quality Manager escalates any overdue action item to the Executive Sponsor for a decision on how to proceed.
- 5.11
Report prior action status
Quality ManagerThe Quality Manager reports the status of prior action items as a standard input to the next management review meeting.
- 5.12
Archive review records
Document ControllerThe Document Controller archives the management review minutes and supporting inputs in the document management system.
6.Quality checks
- →Every scheduled input area appears on the agenda for each review meeting.
- →Decisions and action items are recorded with a named owner and due date.
- →Overdue action items are escalated to the Executive Sponsor.
- →Prior action item status is reported as an input to the next review.
7.Records
- →Management review agenda and pre-read package
- →Meeting minutes with decisions and action items
- →Action item tracker
- →Archived review inputs
8.KPIs
- →Percentage of management reviews held on schedule
- →Percentage of action items closed on time
- →Number of overdue action items at any given time
- →Trend in quality objective performance across reviews
9.Common mistakes
- →Skipping a standard input area because there's nothing urgent to report.
- →Recording a decision without a named owner or due date.
- →Not following up on action items between meetings.
- →Letting the review become a status readout with no actual decisions made.
10.Revision history
| Revision | Date | Description | Reviewed by |
|---|---|---|---|
| 1.0 | September 15, 2026 | Initial release | Ilia Pirozhenko |
This is a template. Adapt it to your organization, equipment and local regulations before use.
