eQMS Ilmu Hayati 13 butir
QMSR / 21 CFR 820 Transition Readiness Checklist
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Assesses readiness for the FDA Quality Management System Regulation, which incorporates ISO 13485:2016 by reference effective February 2, 2026. Use to gap-assess a legacy QSR quality system against the QMSR.
21 CFR 820 (QMSR, 2024 Final Rule)ISO 13485:201621 CFR 820.35
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Framework Alignment
- Has the quality system been mapped from the former QSR to ISO 13485:2016 as incorporated by the QMSR? *
- Are the QMSR-specific supplementary FDA definitions and requirements integrated (not ISO alone)? *
- Is the quality system operational under QMSR requirements by the February 2, 2026 effective date? *
Records and Retention
- Are records retention requirements met (design/device lifetime, not less than 2 years)? *
- Are confidential records marked and handled per FDA disclosure requirements? *
Labeling and UDI
- Are device labeling and packaging controls maintained per QMSR-specific provisions? *
- Is Unique Device Identification (UDI) applied and consistent with the DI on labels? *
Traceability and Complaint Terminology
- Is device traceability maintained consistent with ISO 13485 7.5.9 and FDA expectations? *
- Have complaint and servicing terms been reconciled between ISO 13485 and FDA definitions? *
Procedures, Training, and Readiness
- Have SOPs, forms, and the quality manual been updated to reflect QMSR terminology and structure? *
- Has affected personnel been trained on the QMSR/ISO 13485 quality system changes? *
- Has an internal gap audit against the QMSR been completed and gaps remediated via CAPA? *
- Record the target date for full QMSR compliance readiness.
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