Management review

ISO 13485 asks top management to review the quality system at documented planned intervals, using inputs such as feedback, complaints, reports to authorities, audits, process and product monitoring, CAPA and new regulatory requirements. The output records the decisions and actions on improvements, changes and the resources needed. Auditors read these records to see whether management acts on what the system tells it.

Top management shall review the organization's quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness.

ISO 13485:2016, clause 5.6.1

Under the FDA's QMSR, management review follows ISO 13485 clause 5.6. The former QSR exception that kept management review records out of FDA inspections (21 CFR 820.180(c)) was not carried over, so FDA investigators can now ask for them, as notified bodies and MDSAP auditing organizations already do.