REPORTREFERENCE OUTLINE

Quality Management Review Pack

Management review pack assembling PQS performance metrics, deviation/CAPA/change status, and audit outcomes for leadership decisions. Structures the ICH Q10 / ISO 13485 clause 5.6 (QMSR; formerly 21 CFR 820.20) review.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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HOW TO FILL THIS IN
How to Conduct a Management Review, step by step →
REGULATIONS MAPPED
ICH Q1021 CFR Part 820
DOCUMENT TYPE
Report
LAST UPDATED
January 2025
PURPOSE

The pack that puts the pharmaceutical quality system in front of the people accountable for it — performance metrics, open quality events, product performance, and the actions and resources leadership commits to in response. Management review is often documented as an event and treated as a report-out; what makes it useful, and what an inspector looks for, is the record of decisions taken and resources allocated.

What's Inside

✓Review scope, period, and attendees, with the accountable executives named
✓Status of actions from prior reviews, carried forward until closed rather than reset each period
✓PQS performance metrics and trends, chosen because they indicate system health rather than because they are easy to count
✓Deviation, CAPA, and change status, with ageing and overdue items shown rather than totals alone
✓Complaints, recalls, audit outcomes, and regulatory inspection commitments
✓Product quality and process performance, including trends that cross product lines
✓Decisions, actions, owners, and the resources committed — the section that distinguishes governance from reporting

How to Use It

1Fix the review period and the metric set, and keep both stable so trends mean something across reviews
2Carry prior actions forward until they close; a review that restates open actions without ageing them hides the problem
3Show ageing and overdue counts rather than totals — a stable CAPA count with rising age is a deteriorating system
4Bring cross-product and cross-site trends, which no single product review can see
5Record decisions, owners, dates, and the resources committed, in the words the meeting used
6Publish the outcome and track the committed resources, because an unresourced action is a decision not taken
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Review Scope, Period, and Attendees
2Status of Actions from Prior Reviews
3PQS Performance Metrics and KPIs
4Deviations, CAPAs, and Change Control
5Complaints, Recalls, and Audit Outcomes
6Product Quality and Process Performance
7Decisions, Actions, and Resources
8Sign-off
REGULATORY CONTEXT

ICH Q10 requires management review of the pharmaceutical quality system, with defined inputs including process performance and product quality monitoring, audit results, and regulatory inspections, and defined outputs including improvements and resource allocation. For devices, the QMSR (ISO 13485:2016 clause 5.6; formerly 21 CFR 820.20) requires top management to review the quality management system at defined intervals, with the results documented. Neither prescribes the metric set — the choice of indicators is the organisation's, and this pack exists to record it and hold it stable.

MAPPED STANDARDS
ICH Q1021 CFR Part 820
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WHERE NEXT

  1. FILL IT INHow to Conduct a Management Review →The procedure this template records, one step at a time.
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