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ISO 17025 · Testing & Calibration Labs · QC & Analytics

The auditor is coming. Is your lab ready?

Accredited contract labs are under documentation pressure every day. Equipment records, calibration history, error logs, SOP version. LabThunder ensures all records are complete, unalterable, and instantly retrievable. Not just at the next audit. Every day.

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Trusted by

GMP/GLP

ISO 15189

ISO 17025

Customer story · ISO 17025 · Wine Analysis

From Excel chaos to audit-proof documentation in 10 weeks.

Our problem wasn't the lack of a system. It was that nobody enjoyed documenting things. With LabThunder, the barrier is so low that it just happens - usage has increased significantly, without us having to convince anyone to do it. And LabThunder doesn't replace our LIMS - it complements it where it previously fell short.

Fred Langenwalter

Lab Manager & Quality Manager · Zentrallabor Witowski

ISO 17025 certified
since 2008

70^%

less documentation time

Measured in daily operations

107

paper logbooks replaced

Replaced at the customer’s laboratory

10^wk

until full rollout

Actual implementation period

96^%

User satisfaction

User survey result

Does this sound familiar?

Five situations every
ISO-17025-Lab knows.

1 2 3 4 5

„The DAkkS assessment starts in two hours. The assessor asks for the calibration record of last year's HPLC pump. The document is somewhere - in a folder, in an Excel file, maybe with colleague Mayer."
‍
45 minutes of searching. Found: maybe.

The missing calibration record

ISO 17025 Ch. 6.4 requires a complete equipment history. A mid-sized testing lab generates thousands of calibration records, maintenance logs, and training certificates each year. Managing that volume with paper and spreadsheets is operationally unsustainable.

Audit · Traceability · ISO § 6.4

„The lab is ISO 17025 accredited. But its logbooks still run in Excel. The internal audit reveals: entries were altered after the fact - no timestamp, no record of who changed what and when."
‍
A classic finding.

Excel can be edited after the fact

ISO 17025 requires records that are tamper-proof and maintain complete audit trails - with timestamps that cannot be altered. Excel structurally cannot meet this requirement. It's a finding that affects hundreds of labs every year.

Data integrity · ISO § 7.11 · Audit finding

„The HPLC is showing pressure deviations. Nobody knows whether the problem occurred before - the logbook is a paper binder, and the error history exists only in the head of the equipment owner, who is out sick today."

Service technician called out. Cause: incorrect parameter. Cost: €1,400.

A service call that wasn't necessary

60-80% of service technician visits in lab environments would have been avoidable - if equipment knowledge, error history, and manuals had been instantly available. Most equipment failures are user-induced, not device-related.

Audit · Traceable · Avg. €1,800-2,500 per visit ·
Preventability · ISO § 6.4

„Mr. Schmidt was the equipment owner for all chromatography systems for 12 years. He knew which HPLC column caused problems with which method, and what pressure profile was normal."

Since he retired: three unresolved errors, two missed calibration deadlines, one open audit finding.

Knowledge walks out the door with the colleague

80% of lab staff depend on the knowledge of individual people. ISO 17025 Ch. 6.2 requires documented personnel competence - but no system enforces that this knowledge is also documented and made transferable.

Staff turnover · ISO § 6.2 · Knowledge loss

„The QM system requires a logbook entry after every measurement. The reality: most entries get filled in retroactively on Friday afternoon - from memory, incomplete, sometimes simply forgotten."

Not because employees do bad work. But because a paper form between the HPLC and the PC is not a sensible interruption in the workflow.

Documentation as a burden - not a tool

Documentation as a burden - not a toolThe real problem behind all the others: documentation is experienced as an obligation, not as something valuable. The more pressure management applies, the more it's perceived as a burden - and the worse it gets. LabThunder changes this not through pressure, but through design: entries are created directly at the device, in seconds, because the system immediately gives something back to the employee - the equipment history, the last error, the next maintenance date. Documentation shifts from a mandatory chore to a useful tool.

The result: more documentation, better quality, without extra effort. And as a side effect: seamless ISO 17025 compliance.

The core problem · Adoption · Compliance as a byproduct

The common root cause

Not a technology problem.
A knowledge problem.

All five situations share the same root cause: the right knowledge wasn't available at the wrong moment, or documentation was too cumbersome to maintain consistently. LabThunder solves both at once.

70%

less documentation time

10 Wk

until full rollout

38%

ISO nonconformities: equipment. Source: A2LA

The Solution · LabThunder for ISO 17025 Labs

Easier from day one.
ISO 17025 on autopilot.

LabThunder gets used because it makes everyday lab work easier, not because it's mandatory. ISO 17025 compliance happens automatically as a result.

Tamper-proof device log

Every entry is timestamped, immutable, and assigned to a user. Subsequent changes are only possible with a complete audit trail. ISO-17025 compliant from day one - because it’s the simplest way to make an entry.

ISO 6.4

Audit-Trail

Tamper-proof

Automatic calibration monitoring

All inspection equipment intervals are monitored automatically. You receive timely reminders. Calibration certificates are stored directly with the device -including serial number, date, next due date, and the person responsible.

ISO 6.4

Automatic reminder

Test equipment

Complete device history via QR code

Every device has a QR code. Scan it to get instant access to everything: calibration history, error logs, maintenance records, manuals, and SOPs. Available to every employee, instantly, with no searching required.

QR-Code

Instant access

Manuals

Knowledge stays — even when Mr. Schmidt leaves

Practical knowledge, troubleshooting tips, and device-specific quirks - structured, searchable, and available to the entire team directly within the system. No more knowledge walking out the door when a colleague leaves.

ISO 6.2

Thunder Wiki

Knowledge Transfer

Thunder AI - Your virtual device specialist

AI trained on your manuals, logbooks, and error histories. Need information on the GC-MS ion source? Get an answer in seconds - sourced directly from your own documentation, not ChatGPT.

Thunder AI

Troubleshooting

Device Knowledge

Audit preparation in minutes, not days

All records complete, centralized, and instantly exportable. When the audit assessor asks for the calibration history of the scale from 2022, your answer takes 10 seconds, not 45 minutes of searching.

DAkkS

Export

Available immediately

ISO 17025 compliance as a byproduct of everyday lab work.

LabThunder is built so that normal daily use automatically meets the requirements of accredited environments. No separate compliance module. No extra documentation. The next audit is no longer a project - it's routine.

ISO 17025

GMP / GLP

ISO 15189

GDPR

EU Hosting

ISO/IEC 17025:2017 Requirements — LabThunder Coverage
ISO/IEC 17025 Requirement	Clause	LabThunder
Equipment History & Calibration Records	Clause 6.4	✓ Digital equipment logbooks, calibration records and automatic due-date monitoring
Data Integrity & Traceable Records	Clauses 7.5, 7.11 & 8.4	✓ Timestamped records, traceable changes and a complete audit trail
Training & Competence Documentation	Clause 6.2	✓ Centralized documentation of training and competence records
Document Control & SOPs	Clause 8.3	✓ Version-controlled document hub with controlled documents available at the point of use
Nonconforming Work & Corrective Actions	Clauses 7.10 & 8.7	✓ Documentation of equipment issues, troubleshooting activities and corrective actions
Internal Audit Readiness	Clause 8.8	✓ Centralized, searchable and exportable records for efficient audit preparation

Watch the explainer video now

From Excel chaos to audit-proof documentation in 10 weeks.

Five situations everyISO-17025-Lab knows.

The missing calibration record

Excel can be edited after the fact

A service call that wasn't necessary

Knowledge walks out the door with the colleague

Documentation as a burden - not a tool

Easier from day one.ISO 17025 on autopilot.

How long would preparing for your next audit‍take today?

Watch the explainer video now

Five situations every
ISO-17025-Lab knows.

Easier from day one.
ISO 17025 on autopilot.

How long would preparing for your next audit
‍take today?