Cross-Framework Mapping

NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and ProductionvsFDA Quality Management System Regulation (QMSR)

See exactly how NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
9
Gaps Found
35%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production maps to FDA Quality Management System Regulation (QMSR) with 35% coverage across 7 directly mapped controls. Analysis of 20 NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production controls identifies 13 compliance gaps — primarily concentrated in Design and Development.

Source: TheArtOfService Knowledge Graph | 20 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Chapter 4 - ISO 9001 Application(1 mappings)

AQAP-4.1Application of ISO 9001:2015
ISO 13485 Cl. 7.4Purchasing Controls

Performance and Improvement(4 mappings)

AQAP-5.10Internal Audit (NATO)2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)
AQAP-5.12Corrective Action2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)

Chapter 5 - Additional NATO Requirements(2 mappings)

AQAP-5.5Nonconformity Notification2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)

Supplier Control(2 mappings)

AQAP-5.8Subcontractor QMS
ISO 13485 Cl. 7.4Purchasing Controls
AQAP-5.9Government Surveillance
ISO 13485 Cl. 7.4Purchasing Controls

Design and Development(2 mappings)

ISO 13485 Cl. 7.3.1Design and Development Planning2 targets
§ 820.10(b)Device Tracking
§ 820.10(c)Medical Device Reporting

Related Comparisons

Other NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production comparisons

Other FDA Quality Management System Regulation (QMSR) comparisons

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What are the key differences between NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production and FDA Quality Management System Regulation (QMSR)?

NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production has 20 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 34 controls. Direct mapping analysis identifies 7 overlapping controls (35% coverage). The frameworks diverge most significantly in Design and Development, where 7 NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production and FDA Quality Management System Regulation (QMSR)?

Of 20 total NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production controls, 7 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 35% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production to FDA Quality Management System Regulation (QMSR)?

13 NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in Design and Development with 7 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 NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is Design and Development (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.