Document and record control
Controlled documents, approvals, periodic review and retained records.
ISO 13485 · 4.2.4, 4.2.5FDA QMSR · 21 CFR 820.10, Part 11
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Regulatory Coverage
Qevatrix QualityOSqualityos.qevatrix.comRegulatory coverage map
For medical device professionals and manufacturers: every requirement QualityOS is built against, the module that produces the objective evidence, and what that module holds right now. Use it to brief an auditor or to see where your quality system is thin.
United States
FDA QSR / QMSR and Part 11
21 CFR 820 (QMSR, 21 CFR 820.10), 21 CFR Part 11, 21 CFR 803, 21 CFR 806
International
ISO 13485:2016
ISO 13485:2016 (Amd 1:2021), ISO 14971:2019
European Union / United Kingdom
EU GDPR 2016/679 & UK GDPR
GDPR Art. 5, 6, 9, 15–22, 28, 30, 32–34, Chapter V (SCCs), UK GDPR & Data Protection Act 2018
Open module
Change control
Assessed, justified and trained-out changes to the quality system.
ISO 13485 · 4.2.4, 7.3.9FDA QMSR · 21 CFR 820.30(i)
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Corrective and preventive action
Root cause analysis, action plans and verification of effectiveness.
ISO 13485 · 8.5.2, 8.5.3FDA QMSR · 21 CFR 820.100
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Control of nonconforming product
Identification, containment, disposition and escalation to CAPA.
ISO 13485 · 8.3FDA QMSR · 21 CFR 820.90
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Risk management
Hazard analysis, risk controls, residual risk and benefit-risk conclusion.
ISO 14971 · Clauses 5–10ISO 13485 · 7.1
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Complaint handling and vigilance
Complaint intake, reportability decision and authority reporting.
ISO 13485 · 8.2.2FDA · 21 CFR 820.198, 21 CFR 803
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Internal audit
Planned audit programme with classified findings closed through CAPA.
ISO 13485 · 8.2.4FDA QMSR · 21 CFR 820.22
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Management review
Clause 5.6.2 inputs reviewed and 5.6.3 outputs recorded and signed.
ISO 13485 · 5.6FDA QMSR · 21 CFR 820.20(c)
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Competence and training
Assigned, completed and evidenced training against controlled documents.
ISO 13485 · 6.2FDA QMSR · 21 CFR 820.25
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Purchasing and supplier control
Supplier qualification, risk rating and periodic re-evaluation.
ISO 13485 · 7.4FDA QMSR · 21 CFR 820.50
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Regulatory and standards monitoring
Monitoring of new or revised requirements and applicable standards.
ISO 13485 · 5.6.2(k)
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