# Management Review Template for ISO 13485 (Agenda and Minutes)

> Source: https://netray.co/tools/iso-13485-management-review-template-clause-5-6
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

An ISO 13485 management review agenda and minutes covering every clause 5.6.2 input and 5.6.3 output, with action tracking and sign-off.

## Category

quality

## Industry

Medical Devices

## Audience

- Med device quality manager
- Regulatory affairs
- Top management

## Tool

**Kind:** template

**Output:** document

**Fields:**

#### Company

**Key:** company

**Type:** text

**Default:** Meridian Medical Components Inc.

#### Meeting date

**Key:** date

**Type:** date

**Default:** 2026-10-21

#### Review period

**Key:** period

**Type:** text

**Default:** 1 Oct 2025 to 30 Sep 2026

#### Chair (top management)

**Key:** chair

**Type:** text

**Default:** J. Okafor, CEO

#### Attendees

**Key:** attendees

**Type:** textarea

**Default:** J. Okafor (CEO), L. Chen (Quality), M. Patel (Regulatory), D. Smith (Operations), R. Alvarez (Engineering)

#### Follow-up from previous reviews

**Key:** prev

**Type:** textarea

**Default:** Action 24-03 (supplier re-evaluation for sterilizer) closed. Action 24-05 (complaint trending dashboard) in progress, due Dec.

#### Feedback and complaint handling

**Key:** feedback

**Type:** textarea

**Default:** 14 complaints, 2 reportable events evaluated, none met reporting criteria. Top cause: packaging seal variation.

#### Reporting to regulatory authorities

**Key:** reg

**Type:** textarea

**Default:** No vigilance or MDR submissions required. Field safety notices: none.

#### Audits (internal, external, supplier)

**Key:** audits

**Type:** textarea

**Default:** Internal audit: 6 findings, 4 closed. Surveillance audit: 1 minor nonconformity, closed.

#### Process monitoring and product monitoring

**Key:** process

**Type:** textarea

**Default:** First pass yield 97.8 percent. Final inspection rejects trending down. Sterile barrier seal strength within limits.

#### Corrective and preventive action

**Key:** capa

**Type:** textarea

**Default:** 9 CAPAs opened, 7 closed, 2 open with effectiveness check due next quarter.

#### Changes that could affect the QMS, and new regulatory requirements

**Key:** changes

**Type:** textarea

**Default:** EU MDR transition timeline updated. New contract sterilizer site pending qualification.

#### Recommendations for improvement

**Key:** improve

**Type:** textarea

**Default:** Add seal strength SPC at the pouch machine. Introduce a quarterly supplier risk review.

#### Output: improvement to the QMS and its processes

**Key:** out_qms

**Type:** textarea

**Default:** Approve SPC project and update procedure for supplier risk review.

#### Output: improvement of product related to customer requirements

**Key:** out_prod

**Type:** textarea

**Default:** Revise pouch seal specification after validation.

#### Output: changes needed for regulatory requirements

**Key:** out_reg

**Type:** textarea

**Default:** Update technical documentation index for the MDR timeline.

#### Output: resource needs

**Key:** out_res

**Type:** textarea

**Default:** 0.5 FTE validation engineer for 6 months. Budget for one SPC licence.

**Blocks:**

#### Management Review Minutes (ISO 13485 clause 5.6)

**Body:** Organization: {{company}}
Date: {{date}}
Period reviewed: {{period}}
Chair: {{chair}}

#### Attendees

**Body:** {{attendees}}

#### Review inputs (clause 5.6.2)

**Table:**

**Columns:**

- Input
- Summary and data

**Rows:**

**0:** Follow-up actions from previous reviews

**1:** {{prev}}

**0:** Feedback

**1:** {{feedback}}

**0:** Complaint handling

**1:** See feedback and complaint summary above

**0:** Reporting to regulatory authorities

**1:** {{reg}}

**0:** Audits

**1:** {{audits}}

**0:** Monitoring and measurement of processes and product

**1:** {{process}}

**0:** Corrective action and preventive action

**1:** {{capa}}

**0:** Changes that could affect the QMS, new or revised regulatory requirements

**1:** {{changes}}

**0:** Recommendations for improvement

**1:** {{improve}}

#### Review outputs (clause 5.6.3)

**Table:**

**Columns:**

- Output
- Decision

**Rows:**

**0:** Improvement needed to maintain suitability, adequacy and effectiveness of the QMS and its processes

**1:** {{out_qms}}

**0:** Improvement of product related to customer requirements

**1:** {{out_prod}}

**0:** Changes needed to respond to new or revised regulatory requirements

**1:** {{out_reg}}

**0:** Resource needs

**1:** {{out_res}}

#### Action register

**Table:**

**Columns:**

- No.
- Action
- Owner
- Due date
- Status

**Rows:**

**0:** 1

**0:** 2

**0:** 3

#### Approval

**Signatures:**

- Top management
- Management representative or quality manager

**Notes:** The agenda follows the input and output lists in ISO 13485 clause 5.6, paraphrased. Check the current edition and your own quality manual for additional inputs such as regulatory or customer-specific requirements. Keep the signed minutes as a record, with the supporting data attached.

## Content

**Intro:** ISO 13485 clause 5.6 requires top management to review the QMS at planned intervals and keep records. This template turns the required inputs and outputs into a ready agenda and minutes that you fill in once and export for your records.

**Sections:**

#### How to use the template

**Body:** Before the meeting, collect the data for each input and paste a short summary into the matching field. In the meeting, walk through the inputs, then record decisions in the output fields and add actions with owners and dates. Export the minutes to PDF or Word, sign them and file them with the supporting data. Plan the interval in your procedure; annual is a floor many companies exceed, with a quarterly review during growth or after major change.

#### Required inputs and outputs

**Body:** Clause 5.6.2 lists the inputs: feedback, complaint handling, reporting to regulatory authorities, audits, process monitoring, product monitoring, corrective action, preventive action, follow-up from earlier reviews, changes affecting the QMS, recommendations for improvement and new or revised regulatory requirements. Clause 5.6.3 requires recorded outputs covering improvements needed for the QMS and its processes, product improvement related to customer requirements, changes for regulatory requirements and resource needs.

**Bullets:**

- Every input needs data, not opinions
- Every output needs a decision and an owner
- Keep the records required by 5.6.1

#### Making the review useful

**Body:** The strongest management reviews are short on narrative and long on trends. Show complaint counts by cause, CAPA ageing, first pass yield, supplier performance and audit findings over time. Ask top management to commit resources in the meeting, not afterwards. Auditors look for evidence that top management actually decided something and that the action list is followed up at the next review.

#### Common mistakes

**Body:** Many companies treat the meeting as a slide show, miss the regulatory inputs, or write outputs like continue to monitor. Both weaken the record.

**Bullets:**

- Leaving out complaint trends and reporting to authorities
- No resource decision recorded
- Not attaching the data that supports each input

**Cta:** Netray can help gather the review data from ERP, MES and quality systems with a private AI layer that stays on your own servers, so the inputs are ready before the meeting. Ask us how.

**Faq:**

#### How often is a management review required under ISO 13485?

**Answer:** At planned intervals documented in your procedure. The standard does not fix a frequency. Annual is common as a minimum, and many firms review quarterly or semi-annually.

#### Who must attend?

**Answer:** Top management must conduct the review. Include quality, regulatory, operations and engineering leads who can present inputs and own actions.

#### What records must I keep?

**Answer:** Keep the minutes showing the inputs reviewed, the outputs and decisions, and the action items. Supporting data should be retained or referenced.

#### Is this the same as the AS9100 or ISO 9001 management review?

**Answer:** The idea is similar, but ISO 13485 adds medical device inputs such as complaint handling, regulatory reporting and new regulatory requirements. Use this template for 13485 specifically.

## Search terms

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