Evidence is produced while you work — not the night before the audit
LabNote.Light covers the workflows for which ISO/IEC 17025 and ISO 9001 require evidence: from the request through sampling, method, instrument and result to report, deviation, audit and management review. Every change is recorded with time, author and signature.
Workflows by clause
The clauses that need evidence in an audit
Each workflow is a feature in the app — with a link to the module it lives in.
Organisation and people
Who may do what, who is competent, who signed — and how long it stays valid.
17025 · 4
Impartiality and confidentiality
Declarations and conflicts of interest per person, confidentiality commitments with expiry and reminders.
Quality management17025 · 6.2
Personnel and competence
Training plan, records, per-method authorisations and an overview of expiring approvals.
Quality management17025 · 8.2–8.4
Management system and manual
Manual, policy and objectives as controlled documents, records with retention periods in one place.
Quality management9001 · 7.5
Controlled documents
Versions, two-person release, per-person acknowledgement and review reminders before expiry.
Quality management17025 · 8.5 · 9001 · 6.1
Risks and opportunities
Assessment by likelihood and impact, actions with owners and a re-assessment afterwards.
Quality management9001 · 7.5
Certificates and accreditation documents
Accreditation document, certificates and annexes stored with validity and reminders before expiry.
Quality managementTechnical prerequisites
Instruments, rooms, standards and procedures — evidently fit before anything is measured.
17025 · 6.4
Equipment, calibration, qualification
Equipment file with calibration and maintenance due dates, IQ/OQ/PQ, faults — the status sits on the result.
Equipment & calibration17025 · 6.5
Metrological traceability
Reference materials and standards with lot, certificate, shelf life and consumption per measurement.
QC & analytics17025 · 6.3
Facilities and environmental conditions
Environmental monitoring with limits per room, excursions documented instead of noted on paper.
QC & analytics17025 · 6.6
Externally provided services
Suppliers with evaluation and approval, subcontracting including the response coming back to the order.
Quality management17025 · 7.2
Method validation and verification
Method catalogue with validity, validation plans, performance characteristics, verification and revalidation reminders.
QC & analytics17025 · 7.2.2
Flexible scope
Scope maintained per method and matrix, changes within the scope justified traceably.
QC & analytics9001 · 7.1 · GefStoffV
Lab safety as a prerequisite
Hazardous substance register, risk assessments with approval and operating instructions with acknowledgement.
Lab safetyFrom request to test report
The path of the sample — every step with time, person and evidence.
17025 · 7.1
Requests, tenders and contract review
Enquiry, quote, order with the agreed scope, method and date — departures from the order are recorded.
Sample management17025 · 7.3
Sampling
Sampling plans with location, procedure and owner; the record hangs on the sample.
Sample management17025 · 7.4
Handling of test items
Intake, condition, storage location, an unbroken chain of custody plus retention and documented disposal.
Sample management17025 · 7.5
Technical records
Lab journal, worklists and raw data references with versions — corrections overwrite nothing.
Lab journal17025 · 7.6
Measurement uncertainty
Budgets per method, contributions recorded individually, expanded uncertainty reportable on the test report.
QC & analytics17025 · 7.7
Validity of results
Control samples, control charts with warning and action limits, proficiency tests and second-person review before release.
QC & analytics17025 · 7.8
Test reports and statements of conformity
Report templates, specification checks, decision rule, amendments and versioned issues.
QC & analytics17025 · 7.11
Data integrity and access
Roles and permissions per area, electronic signatures and an unbroken change log with time and author.
Quality managementImprove and evidence
What goes wrong gets worked through — and the effectiveness is evidenced.
17025 · 7.10 · 9001 · 10.2
Nonconforming work, OOS and corrective actions
Record the deviation, investigate the cause, define the action with a due date, verify effectiveness and close.
Quality management17025 · 7.9
Complaints
Intake, handling, customer response and links to the order and the test report.
Quality management9001 · 9.2
Internal audits
Audit programme, checklists, findings and the actions derived from them with due dates.
Quality management9001 · 9.1.2 · 10.3
Improvement and customer satisfaction
Improvement suggestions from the team, customer feedback and its path through to implementation.
Quality management9001 · 9.3
Management review and objectives
Inputs, metrics, objectives and decisions in one place, with a history per review.
Quality managementLabNote.Light supports these workflows. The software itself is not accredited or certified and replaces neither your assessment nor your quality management system. The technical judgement stays with your lab.
What you open directly in an audit
No gathering from folders and spreadsheets: the evidence sits on the record it belongs to.
- Training and competence records per person and method, expiring approvals included
- Calibration and maintenance history per instrument with certificate, signature and next due date
- Method validity, validation plan, performance characteristics and uncertainty budget
- Control charts, control samples and proficiency test results per method
- Test reports with versions, amendments, decision rule and two-person release
- Deviations and OOS with cause, action, due date and effectiveness check
- Document control with release, distribution and per-person acknowledgement
- An unbroken change log with time, author and both the old and the new value
Frequently asked questions
- Is LabNote.Light accredited to ISO 17025?
- No. Laboratories are accredited, not software. LabNote.Light supports the workflows you must evidence and keeps that evidence traceable.
- What can I show directly in an audit?
- Training and competence records, calibration and maintenance history per instrument, method validity and validation files, control charts and proficiency tests, test reports with versions and amendments, deviations with effectiveness checks, document control with acknowledgements, and the full change log.
- How are changes and signatures recorded?
- Every change is logged with timestamp, person, old and new value; the log cannot be altered afterwards. Releases are electronic signatures with re-authentication and the meaning of the signature.
- Can assessors look into the evidence?
- You can give assessors read-only access with a limited scope or export the evidence as a file. Both stay logged.
- Is a flexible scope supported?
- Yes. The scope is maintained per method and matrix; changes within the scope are recorded with a rationale and a release.
- Can we start with a single module?
- Yes. Modules can be switched on individually. Many labs start with equipment and methods and add reporting and quality management later.
- Where is the data stored?
- In Frankfurt, Germany. Data processing agreement under Art. 28 GDPR, encrypted at rest.
Security & Compliance
Built into every plan, not bolted on
GDPR, ALCOA+, and the hash-chain audit trail ship with every LabNote.Light plan — no add-ons, no surcharge, EU-hosted.
Start with one module
Equipment and methods first, reporting and quality management later — the data stays the same.