Management Review
Top-management evaluation of QMS performance at planned intervals.
Definition
ISO 13485 clause 5.6 and 21 CFR 820.20 require top management to review the QMS at defined intervals, evaluating audit results, customer feedback, process performance, CAPA, and the need for resources or improvement. Typical inputs include feedback and complaints, audit results, process monitoring, product conformity, CAPA status, follow-up from previous reviews, changes affecting the QMS, new regulatory requirements and reports to authorities. Outputs must cover improvements to the QMS and processes, changes to meet regulatory requirements and resource needs. Under the QMSR, management review records are no longer exempt from FDA inspection.What this means in practice
Management reviews should produce documented decisions and actions. Inspectors often request meeting minutes and follow-up evidence.Examples
- A MedTech company reviews its QMS annually, where top management examines internal audit reports, customer complaint trends, and production output data to decide on resource allocation for new equipment.
- During a management review, a manufacturer identifies a recurring issue with product non-conformities and decides to initiate a corrective action plan, including retraining production staff.
- Following new regulatory updates, a management review meeting assesses the impact on the QMS and approves changes to design control procedures to maintain compliance with EU MDR Annex I.
- •Failing to document management review outputs, including decisions and actions, can lead to audit findings.
- •Not involving appropriate top management personnel in the review process undermines its effectiveness and regulatory compliance.
- •Conducting reviews as a mere formality, without genuine critical evaluation and follow-up on identified actions, is a common pitfall.
- •Excluding crucial inputs, such as audit results, customer feedback, or process performance data, can result in an incomplete and ineffective review.
- •Delaying or omitting corrective and preventive actions (CAPA) identified during management review can lead to systemic quality issues and regulatory non-compliance.
Frequently asked questions
Cross-references
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Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPlanned, independent evaluation of QMS conformity and effectiveness.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
International standard for medical device quality management systems.
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· Same categoryAbility of a material to perform with an appropriate host response in a specific application.
Verification step confirming a corrective or preventive action actually fixed the problem.
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Process for receiving, evaluating, and responding to device complaints.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1ISO 13485:2016Tier 1 VerifiedISOiso.org
- 2AAMI - Quality Systems ResourcesTier 2 VerifiedAAMIaami.org
- 3MDIC Case for QualityTier 4 VerifiedMDICmdic.org
Inline markers like [1] jump to the matching reference above.