Almost everything an assessor asks for is one click away in Crelio — from IQC and critical callouts to the LIS validation certificate. For the few things it isn't, there's a free template. This is the map.
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ISO 15189 clauses mapped — all covered
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already answered on a live Crelio screen
IQ·OQ·PQ
LIS validation certificate, from us
For your NABL file
The documents we hand you
The proof NABL wants for your software is ready on request: the LIS validation certificate (IQ / OQ / PQ), the Backup & Restore Policy (RPO/RTO), and our information-security / ISO 27001 documentation. The vendor covers the system, so your lab never builds this from scratch.
A practical NABL prep guide for Crelio labs — and a look at how much of the audit is already handled for you. For each ISO 15189 / NABL requirement: the exact Crelio
screen that answers it — or, where Crelio doesn't go directly, the easiest free way to cover it (a Google
Sheet, a Drive folder, a ready template). Green = in Crelio; soft-green = a standard record you keep on file; amber = partly in Crelio; blue = a free tool with a downloadable template.
Standards: ISO 15189:2022 · NABL 112A · NABL 112B · NABL 128Verdicts from: live product screens
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In Crelio — show the assessor
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In place — a standard record on file
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Partly in Crelio — plus a free tool
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Free tool — a downloadable template does it
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Every ISO 15189 clause, mapped
In Crelio In place (on file) Partly in Crelio + free tool Free tool + template
How to use this: Crelio already runs the operational, analytical, authorization, reporting and audit-trail
layers as working screens — for those, you just show the assessor the screen. For the few things no LIMS owns —
PT/EQAS, CAPA closure, document control, internal audit, management review — every card below carries a
free path: the easiest zero-cost tool and a ready-to-copy template. Set up the free stack once, and your
whole audit is either a screen or a checklist.
🧰 The free stack — set up once
Everything Crelio doesn't do directly can be covered — for entry-level and small labs — with free tools you
likely already have. Set these up once and the amber/blue cards below turn into checklists instead of blockers.
Get the full toolkit by email →14 registers pre-filled with sample data + 7 starter SOPs, in one file. Enter your email below and we send it over. (Individual templates above download instantly.)
Google Drive + DocsControlled documents — folders, a naming rule, and built-in version history as your change trail.
Honest note: the free stack needs discipline and manual upkeep — perfect to get accredited and for
small labs. CrelioHealth can automate these same registers and pull the data from your Crelio account once that upkeep stops scaling.
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Want this handled for you?
The free paths above will get a small or entry-level lab accredited. When manual upkeep across Sheets and Drive
stops scaling — more locations, more disciplines, surveillance pressure — CrelioHealth can automate
these same modules and pull the data straight from your Crelio account, so there is no double entry. Talk to us for a walkthrough.
Documents to request from CrelioHealth
Ask your CrelioHealth account or IT/security team for these — they cover the software side of your NABL file, so your lab doesn't build them.
Ready
LIS Validation Certificate (IQ / OQ / PQ)
cl. 7.6
Proof the LIS is validated for its intended use.
Ready
Backup & Restore Policy
cl. 7.8
RPO/RTO, restore testing, ISO 27001-mapped (POL-07).
ISO 27001 & SOC 2 certificates
cl. 7.6 · 4.2
Independent security assurance for the platform.
Information Security Policy
cl. 7.6
How data is protected, access-controlled and logged.
Data Privacy statement (DPDP / HIPAA)
cl. 4.2 · 4.3
Handling of patient data under applicable law.
Access-control & user-management policy
cl. 4.2 · 7.6
Role-based access, unique logins, audit trail.
SLA / uptime report
cl. 7.8 · 6.x
Availability commitment and actual uptime.
Change management / release notes
cl. 7.6
How software changes are controlled and communicated.
VAPT (penetration-test) summary
cl. 7.6
Security-testing evidence, on request.
Get the full NABL toolkit — free
Enter your details and we'll email you the toolkit: 14 registers pre-filled with sample data and 7 starter SOPs. The CrelioHealth team will follow up to help you get audit-ready.
We use your email and phone only to send the toolkit and help you with NABL readiness.