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Cross-Framework Mapping

FDA Quality Management System Regulation (QMSR)vsIATF 16949:2016 - Quality Management System for Automotive Production

See exactly how FDA Quality Management System Regulation (QMSR) controls map to IATF 16949:2016 - Quality Management System for Automotive Production. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
6
Gaps Found
31%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA Quality Management System Regulation (QMSR) maps to IATF 16949:2016 - Quality Management System for Automotive Production with 31% coverage across 4 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 9 compliance gaps — primarily concentrated in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status.

Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(7 mappings)

QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)2 targets
→IATF16949-Clause10-Improvement-Nonconformity-CorrectiveAction-Problem-ErrorProofIATF 16949 Clause 10 - Improvement + Nonconformity + Corrective Action + Problem Solving + Error Proofing + Continual Improvement
→IATF16949-Clause4-Context-Scope-CustomerSpecific-ProductSafetyIATF 16949 Clause 4 - Context of Organization + QMS Scope + Customer Specific Requirements + Product Safety
QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)2 targets
→IATF16949-Clause10-Improvement-Nonconformity-CorrectiveAction-Problem-ErrorProofIATF 16949 Clause 10 - Improvement + Nonconformity + Corrective Action + Problem Solving + Error Proofing + Continual Improvement
→IATF16949-Clause9-Performance-Monitoring-InternalAudit-ManagementReviewIATF 16949 Clause 9 - Performance Evaluation + Monitoring + Internal Audit + Manufacturing Process Audit + Management Review
QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)
→IATF16949-Clause8-Supplier-QMS-Development-Externally-ProvidedIATF 16949 Clause 8 Supplier - Control of Externally Provided Processes + Type and Extent + Supplier QMS Development
QMSR-ISO13485-Sec8Measurement, analysis and improvement (ISO 13485:2016 Section 8)2 targets
→IATF16949-Clause10-Improvement-Nonconformity-CorrectiveAction-Problem-ErrorProofIATF 16949 Clause 10 - Improvement + Nonconformity + Corrective Action + Problem Solving + Error Proofing + Continual Improvement
→IATF16949-Clause4-Context-Scope-CustomerSpecific-ProductSafetyIATF 16949 Clause 4 - Context of Organization + QMS Scope + Customer Specific Requirements + Product Safety

Related Comparisons

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Other IATF 16949:2016 - Quality Management System for Automotive Production comparisons

USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement) vs IATF 16949:2016 - Quality Management System for Automotive Production6 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs IATF 16949:2016 - Quality Management System for Automotive Production6 mappingsAS9100D - Aerospace Quality Management System vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappingsISO/IEC 27003:2017 vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappingsISO/IEC 27014:2020 vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappingsGerman Supply Chain Due Diligence Act (LkSG) vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappingsAnnex 11 to EU GMP - Computerised Systems vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappingsIAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1) vs IATF 16949:2016 - Quality Management System for Automotive Production5 mappings

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What are the key differences between FDA Quality Management System Regulation (QMSR) and IATF 16949:2016 - Quality Management System for Automotive Production?

FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while IATF 16949:2016 - Quality Management System for Automotive Production covers 10 controls. Direct mapping analysis identifies 4 overlapping controls (31% coverage). The frameworks diverge most significantly in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status, where 2 FDA Quality Management System Regulation (QMSR) controls have no direct IATF 16949:2016 - Quality Management System for Automotive Production equivalent.

How many controls map between FDA Quality Management System Regulation (QMSR) and IATF 16949:2016 - Quality Management System for Automotive Production?

Of 13 total FDA Quality Management System Regulation (QMSR) controls, 4 map directly to IATF 16949:2016 - Quality Management System for Automotive Production controls — representing 31% coverage. The remaining 9 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to IATF 16949:2016 - Quality Management System for Automotive Production?

9 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in IATF 16949:2016 - Quality Management System for Automotive Production. The highest concentration of gaps is in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status with 2 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between FDA Quality Management System Regulation (QMSR) and IATF 16949:2016 - Quality Management System for Automotive Production?

The domain with the highest gap count is QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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