Cross-Framework Mapping

ISO 15189:2022 — Medical Laboratories Requirements for Quality and CompetencevsAS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence

See exactly how ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls map to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence. Pre-computed mappings, identified gaps, and coverage analysis.

28
Controls Mapped
36
Gaps Found
17%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence maps to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence with 17% coverage across 11 directly mapped controls. Analysis of 64 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls identifies 53 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 64 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 28 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Clause 5: Structural and Governance Requirements(4 mappings)

ISO-15189-5.1Legal entity
9.2Network Domain Security
ISO-15189-5.4Structure and authority
9.2Network Domain Security
ISO-15189-5.6Risk management2 targets
AS9100D-8.1Operational Planning and Control
ISO27003-8.3Information Security Risk Treatment

Clause 6: Resource Requirements(16 mappings)

ISO-15189-6.3Facilities and environmental conditions6 targets
4.1External Standards
4.2Building Fabric and Facilities
5.3Management of Allergens
7.1Training and Competence
8.5Production and Service Provision
8.5.2Identification and Traceability
ISO-15189-6.5Equipment calibration and metrological traceability6 targets
4.1External Standards
4.2Building Fabric and Facilities
5.3Management of Allergens
7.1Training and Competence
8.5Production and Service Provision
8.5.2Identification and Traceability
ISO-15189-6.7Service agreements
9.2Network Domain Security
ISO-15189-6.8Externally provided products and services2 targets
AS9100D-8.4Control of Externally Provided Processes, Products, and Services
ISO27003-8.1Operational Planning and Control
ISO-17025-6.5Metrological traceability
4.1External Standards

+8 more mappings

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Related Comparisons

Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons

Other AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence comparisons

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What are the key differences between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence has 64 controls across its framework, while AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence covers 38 controls. Direct mapping analysis identifies 11 overlapping controls (17% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 19 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence equivalent.

How many controls map between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

Of 64 total ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls, 11 map directly to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence controls — representing 17% coverage. The remaining 53 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

53 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence. The highest concentration of gaps is in Clause 7: Process Requirements with 19 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

The domain with the highest gap count is Clause 7: Process Requirements (19 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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