Cross-Framework Mapping

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration LaboratoriesvsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

See exactly how ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.

37
Controls Mapped
53
Gaps Found
17%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 17% coverage across 15 directly mapped controls. Analysis of 90 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls identifies 75 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 90 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 37 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

General(1 mappings)

17025-4.2Confidentiality
6.6Confidentiality or non-disclosure agreements

Clause 4: General Requirements(2 mappings)

ISO-15189-4.2Confidentiality
6.6Confidentiality or non-disclosure agreements
ISO-17025-4.2Confidentiality
6.6Confidentiality or non-disclosure agreements

Clause 6: Resource Requirements(14 mappings)

ISO-15189-6.3Facilities and environmental conditions3 targets
8.5Control effectiveness review
ISO-15189-6.5Equipment calibration and metrological traceability
ISO-17025-6.5Metrological traceability
ISO-15189-6.5Equipment calibration and metrological traceability3 targets
8.5Control effectiveness review
ISO-15189-6.3Facilities and environmental conditions
ISO-17025-6.5Metrological traceability
ISO-15189-6.7Service agreements4 targets
6.5Preparing and Distributing Audit Report
6.7Conducting Audit Follow-up
ISO-15189-5.1Legal entity
ISO-15189-5.4Structure and authority
ISO-15189-6.8Externally provided products and services
A.1Point-of-Care Testing Additional Requirements
ISO-17025-6.5Metrological traceability3 targets
8.5Control effectiveness review
ISO-15189-6.3Facilities and environmental conditions
ISO-15189-6.5Equipment calibration and metrological traceability

Clause 7: Process Requirements(2 mappings)

ISO-15189-7.4Post-examination processes2 targets
ISO-15189-5.6Risk management
ISO-15189-8.4Control of records

Clause 8: Management System Requirements(1 mappings)

ISO-15189-8.1General requirements
ISO-17025-8.1Options

+17 more mappings

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Related Comparisons

Other ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories comparisons

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

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What are the key differences between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories has 90 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 15 overlapping controls (17% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.

How many controls map between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

Of 90 total ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls, 15 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 17% coverage. The remaining 75 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

75 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Clause 7: Process Requirements with 18 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/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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