The Management Review Problem: Book a Demo

Management review, quality review and design review meetings are where quality decisions are made and where auditors look for proof that leadership is engaged. The meeting itself is rarely the challenge. Keeping a complete, controlled record of it is.

The eLeaP Solution:

Give every quality meeting a controlled home. eLeaP Meetings records management reviews, quality reviews, design reviews and audit meetings in the same system that holds the quality data they discuss. → Talk to an Expert or start a free trial.

Management Reviews and Quality Meetings, Recorded and Signed Off

Top management review is a requirement of ISO 13485 clause 5.6, ISO 9001 clause 9.3, AS9100 and IATF 16949. Because the FDA’s Quality Management System Regulation incorporates ISO 13485:2016, medical device manufacturers carry the same expectation in the United States. The standards ask for planned reviews at defined intervals, documented inputs, documented outputs and retained records.

eLeaP Meetings sits under the Events module and gives your team one place to schedule, run and sign off formal meetings. Each meeting carries its type, date, location, chairperson, attendees and status, so the record of every review is complete, searchable and ready when an auditor asks how management oversees the quality system.

Key Features

What a Management Review Draws On

Management review is most useful when the discussion starts from current facts. The inputs your standards describe already live in eLeaP modules, so the evidence for a review is collected from one platform. The table shows where each common input lives. Your procedures define the exact inputs and outputs your organization reviews.

Typical review input Where it lives in eLeaP
Results of audits Audit management: audit scores, findings and their closure status.
Nonconformities, corrective and preventive actions Events and CAPA: investigations, actions and effectiveness checks.
Risks and opportunities Risk management: the risk acceptability matrix and linked control measures.
Changes that could affect the quality system Change control: change requests and change orders across the organization.
Supplier performance and approval status Supplier management: approval status, risk level, renewals and supplier audits.
Design and development status Design controls: items not yet verified or validated and design review progress.
Training and competence Training management: assignments, completions and records.
Follow-up from previous reviews The action items recorded with earlier meetings.

What You Get with eLeaP Meetings

Why Select eLeaP Quality?

Meetings are most valuable when they connect to the data they discuss. eLeaP brings document control, risk, events, audits, suppliers, change control and Learning Management into one platform, so the records behind a review are already in the same system as the review itself.

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Standards Supported

ISO 13485:2016 clause 5.6 | FDA QMSR
ISO 9001 clause 9.3 | AS9100 | IATF 16949
ISO 19011 clause 6.4
21 CFR Part 11

Meeting Types

Management Review
Quality Review
Design Review
Audit Opening and Closing Meetings
Your Own Custom Types

Proven Benefits:

Take the next step toward management reviews that leave a clean, complete record. Start your free trial below or schedule a demo today.

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Meetings is part of the comprehensive eLeaP Quality Management System.

Meetings FAQs

Explore Related Capabilities

Meetings work best connected to the audits, actions, risks and changes they review.

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