26% of ISO 15189:2022 you already have
NIST SP 800-171 already covers about 26% of ISO 15189:2022, leaving
55 of 74 controls as genuinely new work.
Already covered 0
Likely covered 19
New work 55
No control in NIST SP 800-171
maps directly to one in ISO 15189:2022. Everything counted as covered is covered because both
map to the same third standard, which is what a crosswalk is, but it is an inference rather
than a lookup.
What is genuinely new work
Nothing in NIST SP 800-171 reaches these. This is the list to scope.
27006-6.1Competence of personnel
27006-6.2Personnel Records
5.4Establishing Audit Programme
6.8Externally Provided Products and Services
7.8Consequence estimation
ISO-15189-4.1Impartiality
ISO-15189-4.2Confidentiality
ISO-15189-4.3Requirements regarding patients
ISO-15189-5.2Laboratory director
ISO-15189-5.3Laboratory activities
ISO-15189-5.5Objectives and policies
ISO-15189-6.6Reagents and consumables
ISO-15189-7.2Pre-examination processes
ISO-15189-7.3Examination processes
ISO-15189-7.5Nonconforming work
ISO-15189-7.6Data and information management
ISO-15189-8.1General requirements
ISO-15189-8.2Management system documentation
ISO-15189-8.3Control of documents
ISO-15189-8.5Actions addressing risks and opportunities
ISO-15189-8.7Nonconformities and corrective actions
ISO-15189-8.9Management reviews
ISO-17025-4.1Impartiality
ISO-17025-4.2Confidentiality
ISO-17025-6.3Facilities and environmental conditions
ISO-17025-6.6Externally provided products and services
ISO-17025-7.1Review of requests, tenders and contracts
ISO-17025-7.10Nonconforming work
ISO-17025-7.11Control of data and information management
ISO-17025-7.2Selection, verification and validation of methods
ISO-17025-7.4Handling of test or calibration items
ISO-17025-7.5Technical records
ISO-17025-7.6Evaluation of measurement uncertainty
ISO-17025-7.7Ensuring the validity of results
ISO-17025-7.8Reporting of results
ISO-17025-8.2Management system documentation
ISO-17025-8.3Control of management system documents
ISO-17025-8.4Control of records
ISO-17025-8.5Actions to address risks and opportunities
ISO-17025-8.7Corrective actions
ISO-17025-8.8Internal audits
ISO-17025-8.9Management reviews
Show the 19 you already have
6.4Logging and Monitoring
6.5Preparing and Distributing Audit Report
6.6Confidentiality or non-disclosure agreements
6.7Conducting Audit Follow-up
8.5Control effectiveness review
8.8Management of technical vulnerabilities
A.1Point-of-Care Testing Additional Requirements
ISO-15189-5.1Legal entity
ISO-15189-5.4Structure and authority
ISO-15189-5.6Risk management
ISO-15189-6.3Facilities and environmental conditions
ISO-15189-6.5Equipment calibration and metrological traceability
ISO-15189-6.7Service agreements
ISO-15189-6.8Externally provided products and services
ISO-15189-7.4Post-examination processes
ISO-15189-7.8Continuity and emergency preparedness
ISO-15189-8.4Control of records
ISO-17025-6.5Metrological traceability
How this is calculated
Already covered means a mapping runs from a control in NIST SP 800-171 to that control. Likely
covered means no direct mapping exists but both frameworks map to the same control in a third
standard. New work means neither. We keep those separate rather than adding them into one
friendlier number, because blending them would present a two-hop inference as a verified
fact.
Coverage is not symmetric.
Run it the other way and you will get a
different number; both are correct.
From 332,959 cross-framework control
mappings across 723 frameworks, 531 of them verified against
their source documents. It does not tell you that you are compliant: a mapped control means
the two standards ask for the same thing, not that you have done it.
Try another pair ยท
Today's edition