Cross-Framework Mapping

Automotive SPICE (ASPICE) v4.0 - Process Assessment ModelvsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

See exactly how Automotive SPICE (ASPICE) v4.0 - Process Assessment Model controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.

24
Controls Mapped
7
Gaps Found
10%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Automotive SPICE (ASPICE) v4.0 - Process Assessment Model maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 10% coverage across 6 directly mapped controls. Analysis of 31 Automotive SPICE (ASPICE) v4.0 - Process Assessment Model controls identifies 46 compliance gaps — primarily concentrated in Software Engineering.

Source: TheArtOfService Knowledge Graph | 31 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 24 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Acquisition Process Group(2 mappings)

ACQ.4Supplier Monitoring2 targets
A.1Point-of-Care Testing Additional Requirements
ISO-15189-6.8Externally provided products and services

Management, Acquisition, and Validation(2 mappings)

ACQ.4Supplier Monitoring2 targets
A.1Point-of-Care Testing Additional Requirements
ISO-15189-6.8Externally provided products and services

Machine Learning Engineering (v4.0 new)(10 mappings)

MLE.1Machine Learning Requirements Analysis5 targets
6.5Preparing and Distributing Audit Report
6.7Conducting Audit Follow-up
ISO-15189-5.1Legal entity
ISO-15189-5.4Structure and authority
ISO-15189-6.7Service agreements
MLE.3Machine Learning Training5 targets
6.5Preparing and Distributing Audit Report
6.7Conducting Audit Follow-up
ISO-15189-5.1Legal entity
ISO-15189-5.4Structure and authority
ISO-15189-6.7Service agreements

Hardware and Machine Learning Engineering(6 mappings)

MLE.1Machine Learning Requirements Analysis5 targets
6.5Preparing and Distributing Audit Report
6.7Conducting Audit Follow-up
ISO-15189-5.1Legal entity
ISO-15189-5.4Structure and authority
ISO-15189-6.7Service agreements
MLE.3Machine Learning Training
6.5Preparing and Distributing Audit Report

+4 more mappings

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Related Comparisons

Other Automotive SPICE (ASPICE) v4.0 - Process Assessment Model comparisons

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

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What are the key differences between Automotive SPICE (ASPICE) v4.0 - Process Assessment Model and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

Automotive SPICE (ASPICE) v4.0 - Process Assessment Model has 31 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 6 overlapping controls (10% coverage). The frameworks diverge most significantly in Software Engineering, where 6 Automotive SPICE (ASPICE) v4.0 - Process Assessment Model controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.

How many controls map between Automotive SPICE (ASPICE) v4.0 - Process Assessment Model and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

Of 31 total Automotive SPICE (ASPICE) v4.0 - Process Assessment Model controls, 6 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 10% coverage. The remaining 46 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Automotive SPICE (ASPICE) v4.0 - Process Assessment Model to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

46 Automotive SPICE (ASPICE) v4.0 - Process Assessment Model controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Software Engineering with 6 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 Automotive SPICE (ASPICE) v4.0 - Process Assessment Model and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

The domain with the highest gap count is Software Engineering (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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