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ISO 15189:2022 - Medical Laboratories Requirements for Quality and CompetencevsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

See exactly how ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls map to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. Pre-computed mappings, identified gaps, and coverage analysis.

49
Controls Mapped
28
Gaps Found
23%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence maps to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements with 23% coverage across 18 directly mapped controls. Analysis of 77 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls identifies 59 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 77 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 49 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Resource Requirements(16 mappings)

6.4Logging and Monitoring2 targets
→3.7Establish and Maintain a Data Classification Scheme
→3.7.1Key generation procedures
6.5Preparing and Distributing Audit Report5 targets
→3.3Configure Data Access Control Lists
→3.7Establish and Maintain a Data Classification Scheme
→3.7.1Key generation procedures
→FEDRAMP-CM-6Configuration Settings
→FEDRAMP-CP-9System Backup
6.6Confidentiality or non-disclosure agreements3 targets
→FEDRAMP-SC-13Cryptographic Protection
→FEDRAMP-SC-28Protection of Information at Rest
→FEDRAMP-SC-8Transmission Confidentiality and Integrity
6.7Conducting Audit Follow-up6 targets
→3.3Configure Data Access Control Lists
→FEDRAMP-CM-6Configuration Settings
→FEDRAMP-CP-9System Backup
→FEDRAMP-SC-13Cryptographic Protection
→FEDRAMP-SC-28Protection of Information at Rest
→FEDRAMP-SC-8Transmission Confidentiality and Integrity

Management System(3 mappings)

8.5Control effectiveness review3 targets
→3.1Physical Security
→3.2Establish and Maintain a Data Inventory
→3.4Enforce Data Retention

Annex A(1 mappings)

A.1Point-of-Care Testing Additional Requirements
→3.16System and Services Acquisition

+29 more mappings

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Related Comparisons

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

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO/IEC 17025:2017 - General Requirements for Testing and Calibration31 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products17 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories17 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs BRCGS Global Standard for Food Safety Issue 914 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs AS9100D - Aerospace Quality Management System14 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO/IEC 27003:201714 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ICH Q10 - Pharmaceutical Quality System13 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs IEC 62304:2015 Medical Device Software Lifecycle Processes13 mappings

Other NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements comparisons

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements20 mappingsNIST SP 800-53 Rev 5 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements18 mappingsMTCS (Singapore) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements17 mappingsNIST Privacy Framework vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements16 mappingsNIST SP 800-146 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-145 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-144 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsISMAP (Japan) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappings

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What are the key differences between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 77 controls across its framework, while NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements covers 35 controls. Direct mapping analysis identifies 18 overlapping controls (23% 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements equivalent.

How many controls map between ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

Of 77 total ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, 18 map directly to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls — representing 23% coverage. The remaining 59 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

59 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

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.

Related Resources

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

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