Management Review Example: Agenda, Inputs, Outputs and Minutes (ISO 13485 / AS9100)
Management review is where top management checks that the quality system is suitable, adequate and effective and decides what resources and changes are needed. This management review example gives a filled-in agenda, inputs, outputs and action log that you can adapt for ISO 13485 or AS9100.
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ISO 13485 Management Review Example and Minutes Template
Management Review Minutes
Organization: Meridian Medical Components Inc. Date: 2026-10-08 Standard: ISO 13485 Chair: Plant director Attendees: Plant director, quality manager, operations manager, regulatory affairs lead, purchasing manager, engineering manager
1. Agenda
1. Actions from the previous review 2. Changes that could affect the quality management system, including regulatory changes 3. Review inputs 4. Review outputs, decisions and resource needs 5. Action log and next review date
2. Review inputs
Audits (internal, external, customer): Four internal audits completed; 1 major and 3 minor nonconformities, 2 closed on time. Notified body surveillance audit: no major findings.
Feedback and complaints: 14 complaints in the period, down from 19. Two reportable events assessed; none met reporting criteria after investigation. On-time delivery 94 percent.
Process performance and product conformity: First pass yield 96.8 percent. Scrap rate 2.1 percent, above the 1.5 percent target. Supplier incoming reject rate 0.9 percent.
Corrective and preventive action, risk management, post-market surveillance: 22 CAPAs open, 5 overdue. Risk management files for two product families updated after post-market data review.
Also reviewed: status of previous actions, new or revised regulatory requirements, supplier performance, adequacy of resources and recommendations for improvement.
3. Review outputs
Conclusion on suitability, adequacy and effectiveness of the quality management system: adequate and suitable, with effectiveness gaps in supplier control and scrap performance.
Decision 1: Approve one additional inspector for incoming inspection to resolve backlog and overdue supplier evaluations.
Decision 2: Set scrap rate target at 1.5 percent and require a root cause study on molding cell 2 by end of quarter.
Changes to the system needed: update supplier evaluation procedure to include a risk-based interval. Resource needs: see decision 1.
4. Action log
| No. | Action | Owner | Due date | Status |
|---|---|---|---|---|
| 1 | Recruit incoming inspector | Operations manager | Open | |
| 2 | Root cause study, molding cell 2 | Engineering manager | Open | |
| 3 | Revise supplier evaluation procedure | Quality manager | Open | |
| 4 | Close overdue CAPAs or re-baseline with justification | Quality manager | Open |
5. Records and next review
These minutes are retained as a quality record. Next scheduled management review: per the management review procedure, at planned intervals.
6. Approval
The numbers are examples only. The required inputs and outputs differ by standard: ISO 13485 clause 5.6 and AS9100D clause 9.3 list them, and AS9100 adds items such as on-time delivery and product conformity. Check your licensed standards and tailor the template to your procedure. Records must show the review took place and what was decided.
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How to use this management review example
Change the sample text to match your own data, delete lines that do not apply and export the minutes to Word or PDF. Collect the inputs before the meeting so that time is spent on decisions, not on reading charts aloud. The chair should be top management, not the quality manager. Make sure every output has a decision, an owner and a date, because auditors look for evidence that the review led to action, not just discussion.
- Circulate inputs a few days before the meeting.
- Keep the sample numbers only as a format guide.
- Record decisions and resource commitments explicitly.
- Track every action to closure in the next review.
Inputs and outputs to cover
Typical inputs include feedback, complaints, audit results, process performance and product conformity, status of corrective and preventive actions, follow-up from earlier reviews, changes that could affect the system, regulatory changes, and recommendations for improvement. ISO 13485 also expects reporting to authorities and risk management to be considered. AS9100 adds delivery performance and the performance of external providers. Outputs normally cover improvement of the system and its processes, product improvement related to customer requirements, changes needed and resource needs.
Common mistakes
Weak reviews are a slide show with no decisions, sign-off by the quality manager alone, copy-pasted minutes with unchanged data, missing inputs such as regulatory changes, and no link between actions and the next review. Another gap is holding the review once a year with no change in between, even when a major event, such as a recall, audit failure or change of site, happened. Use the review to set measurable objectives and then show the trend at the next one.
- No decisions or resource commitments recorded.
- Top management absent from the meeting.
- Required inputs missing from the agenda.
- Old actions never reported on.
Frequently Asked Questions
How often should a management review be held?
At planned intervals set in your procedure. Annually is the minimum most organizations use, though many hold it twice a year or quarterly. Hold an extra review after major events such as a product recall or failed audit.
Who must attend a management review?
Top management must take part and decide. Process owners for quality, operations, regulatory, purchasing and engineering normally attend. The quality manager usually prepares inputs and records minutes but should not be the only decision maker.
What records must be kept from a management review?
Both ISO 13485 and AS9100 require records of the review. Keep the minutes, the input data, the decisions and outputs, and action tracking. Retain them for the period your record control procedure and regulations specify.
Is the AS9100 management review different from ISO 13485?
Largely similar in intent. ISO 13485 puts weight on regulatory requirements, complaints and risk management, while AS9100 adds delivery performance and external provider performance. Merged systems can use one review that covers both lists.
If your inputs come from ERP and QMS data, we can show how a private AI layer on your own servers assembles the review pack. The template is free either way.
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