NABL Audit Preparation Checklist for Testing Labs (ISO 17025)
An actionable, clause-by-clause audit readiness guide and downloadable 8-page printable checklist covering equipment calibration, method verification, Levey-Jennings QC, and NABL 133 ULR compliance.
Complete ISO 17025 mapping
Clipboard printable checklist
Sequential ULR audit rules
Automated in ExactLIMS
Pre-Audit Laboratory Readiness Walkthrough
Mark items as verified to calculate your live audit readiness score. Click "Download Printable PDF" to save the complete 8-page formatted clipboard asset.
Your Laboratory Compliance Score: 20%
4 of 20 core NABL 133 / ISO 17025 compliance clauses marked as verified.
Impartiality & Conflict of Interest Declarations
The laboratory must be structured and managed to safeguard impartiality. Signed declarations must be executed by all analytical chemists, technicians, and directors.
Annual signed impartiality commitments in personnel files; risk assessment log for commercial conflicts.
Confidentiality & Data Protection Agreements
Legal agreements protecting client sample data, formulation proprietary secrets, and non-disclosure obligations.
Signed NDAs for internal staff, third-party instrument service engineers, and waste disposal contractors.
Organizational Structure & Designated Deputies
Documented organogram establishing Technical Manager, Quality Manager, and deputies for all critical roles.
Updated organizational chart with role descriptions and authorized delegation letters during managerial leave.
Personnel Competence & Training Records
Documented competence authorization for each analyst covering sampling, testing, equipment operation, and result evaluation.
Four-phase qualification records (Education -> Training -> Supervised Testing -> Independent Authorization).
Master Asset Register & Calibration Schedule
All testing equipment affecting results must have unique asset codes, manufacturer details, and up-to-date calibration schedules.
Master equipment inventory with serial numbers, commissioning dates, calibration frequency, and location.
Overdue Calibration Bench Lockout
Equipment that has been subjected to overloading, mishandling, or overdue calibration must be taken out of service and labeled.
Defective equipment quarantine log with physical red tags and maintenance verification records.
Calibration Certificates with Metrological Traceability
Calibration certificates must be issued by a NABL or ILAC accredited calibration lab (CC discipline) citing national standard traceability.
Valid calibration reports citing expanded measurement uncertainty (U) and coverage factor (k=2).
Intermediate Equipment Check Logbooks
Intermediate checks must be carried out according to a defined procedure to maintain confidence in calibration status.
Daily zero/span balance checks with calibrated E2 class weights; daily temperature logs for stability chambers/ovens.
NABL Audit Preparation & Internal Assessment Checklist
Testing & Calibration Laboratories Audit Walkthrough Document
| Clause | Audit Checklist Item | Required Physical Evidence / Records | Compliant | NC / Notes |
|---|---|---|---|---|
| Clause 4.1 | Impartiality & Conflict of Interest Declarations The laboratory must be structured and managed to safeguard impartiality. Signed declarations must be executed by all analytical chemists, technicians, and directors. | Annual signed impartiality commitments in personnel files; risk assessment log for commercial conflicts. | ||
| Clause 4.2 | Confidentiality & Data Protection Agreements Legal agreements protecting client sample data, formulation proprietary secrets, and non-disclosure obligations. | Signed NDAs for internal staff, third-party instrument service engineers, and waste disposal contractors. | ||
| Clause 5.5 | Organizational Structure & Designated Deputies Documented organogram establishing Technical Manager, Quality Manager, and deputies for all critical roles. | Updated organizational chart with role descriptions and authorized delegation letters during managerial leave. | ||
| Clause 6.2 | Personnel Competence & Training Records Documented competence authorization for each analyst covering sampling, testing, equipment operation, and result evaluation. | Four-phase qualification records (Education -> Training -> Supervised Testing -> Independent Authorization). |
| Clause | Audit Checklist Item | Required Physical Evidence / Records | Compliant | NC / Notes |
|---|---|---|---|---|
| Clause 6.4.4 | Master Asset Register & Calibration Schedule All testing equipment affecting results must have unique asset codes, manufacturer details, and up-to-date calibration schedules. | Master equipment inventory with serial numbers, commissioning dates, calibration frequency, and location. | ||
| Clause 6.4.10 | Overdue Calibration Bench Lockout Equipment that has been subjected to overloading, mishandling, or overdue calibration must be taken out of service and labeled. | Defective equipment quarantine log with physical red tags and maintenance verification records. | ||
| Clause 6.4.11 | Calibration Certificates with Metrological Traceability Calibration certificates must be issued by a NABL or ILAC accredited calibration lab (CC discipline) citing national standard traceability. | Valid calibration reports citing expanded measurement uncertainty (U) and coverage factor (k=2). | ||
| Clause 6.4.12 | Intermediate Equipment Check Logbooks Intermediate checks must be carried out according to a defined procedure to maintain confidence in calibration status. | Daily zero/span balance checks with calibrated E2 class weights; daily temperature logs for stability chambers/ovens. |
| Clause | Audit Checklist Item | Required Physical Evidence / Records | Compliant | NC / Notes |
|---|---|---|---|---|
| Clause 7.2.1 | Standard Test Method Library (SOP Version Control) The laboratory must use appropriate validated methods from recognized standards (BIS, FSSAI, ISO, AOAC, APHA, USP). | Controlled SOP master index with documented effective dates and withdrawal of superseded versions. | ||
| Clause 7.2.2 | Method Verification Records (LOD, LOQ & Recovery) Before adopting standard methods, the laboratory must verify its ability to achieve stated performance characteristics. | Verification dossiers establishing precision, repeatability, recovery %, linearity, and expanded uncertainty. | ||
| Clause 7.4.2 | Sample Inwarding & Chain of Custody (CoC) Unambiguous identification of samples throughout transport, receipt, preparation, analysis, and retention. | Inward register documenting arrival condition, temperature, preservative status, client requisition form (CRF). | ||
| Clause 6.3 | Environmental Conditions Monitoring Environmental conditions (temperature, humidity, dust) must be controlled and logged to prevent invalidating test results. | Twice-daily calibrated thermo-hygrometer logs in chemical, microbiological, and balance rooms. |
| Clause | Audit Checklist Item | Required Physical Evidence / Records | Compliant | NC / Notes |
|---|---|---|---|---|
| Clause 7.7.1 | Internal Quality Control (IQC) & Control Charts Quality control data must be recorded in such a way that trends are detectable. Control limits and statistical analysis required. | Levey-Jennings charts with ±1SD, ±2SD (warning), and ±3SD (action) limits evaluated per test batch. | ||
| Clause 7.7.2 | Proficiency Testing (PT) & Inter-Lab Comparisons (ILC) Participation in accredited PT programs (ISO 17043) or bilateral inter-laboratory comparisons covering all accredited parameters. | Annual 4-year PT participation plan with z-score evaluation reports and CAPA for any questionable (|z| > 2) results. | ||
| Clause 7.8.2 / NABL 133 | Atomic Sequential ULR Number Generation Test reports issued under accredited scope must bear an unbroken sequential ULR number without skips, gaps, or duplicates. | Continuous ULR counter sequence matching calibration and testing registers with zero unaccounted number gaps. | ||
| NABL 133 Scope Rule | Dual-Mode Scope Protection (/N Suffix & Disclaimers) NABL emblem must only appear on accredited parameters. Mixed reports must clearly flag non-accredited tests with disclaimers. | Audit sample of reports confirming non-accredited tests have emblem stripped, ULR suppressed, and /N suffix appended. |
| Clause | Audit Checklist Item | Required Physical Evidence / Records | Compliant | NC / Notes |
|---|---|---|---|---|
| Clause 8.8 | Comprehensive Annual Internal Audit Internal audits must be conducted at planned intervals covering all managerial and technical testing clauses. | Approved internal audit schedule, qualified auditor competence certificates, and signed audit closure summaries. | ||
| Clause 8.7 | Non-Conformance & CAPA Root Cause Analysis When non-conforming work occurs, the lab must evaluate the root cause, determine corrective action, and verify effectiveness. | CAPA logs documenting 5-Why analysis, immediate containment, corrective action, and 60-day effectiveness review. | ||
| Clause 8.9 | Management Review Meeting (MRM) Minutes Top management must review the management system at planned intervals (at least once per 12 months) covering all mandatory inputs. | Signed MRM agenda and minutes covering QC trends, customer feedback, PT outcomes, resource needs, and audit findings. | ||
| Clause 8.3 | Document Control & Master List of Quality Documents All internal and external documents (quality manual, SOPs, forms) must be uniquely identified, reviewed, and controlled. | Master document register indicating document number, current revision number, issue date, and authorized signatories. |
Auditor Final Sign-Off & Action Plan
Generated via ExactLIMS Quality Resource Engine | www.exactlims.in | Automated ISO 17025 & NABL 133 Compliance
How ExactLIMS Automates 85% of this Checklist Automatically
Instead of scrambling through binders of paper logs before audit day, ExactLIMS embeds ISO/IEC 17025 controls directly into your daily routine bench workflows.
1. Atomic Non-Skip ULR Sequential Counter
Guarantees compliance with NABL 133 by atomically generating sequential ULR numbers within database transaction locks. Eliminates duplicate number race conditions and accidental gaps.
2. Equipment Calibration Dynamic Lockout
Automatically flags instruments due for calibration and locks analysts out from logging test results on overdue or unverified balances, spectrophotometers, or chromatographs.
3. Levey-Jennings & Westgard QC Automation
Plots internal quality control data in real time with ±1SD, ±2SD warning, and ±3SD action limits. Alerts section heads automatically when analytical drift occurs.
4. Dual-Mode Scope Engine (/N Suffix)
Intelligently strips the official NABL emblem, suppresses the ULR, and appends the /N suffix for non-accredited parameters, protecting your license from accidental misuse.
5. Method Versioning & SOP Bench Authorization
Strict 3-tier version control (DRAFT -> EFFECTIVE -> SUPERSEDED). Analysts only execute active standard methods, and outdated SOPs are watermarked and removed instantly.
6. Instant QR Code Verification
Every issued CoA contains an indelible QR code that assessors or clients can scan with any smartphone to verify raw data validity against live electronic records.
NABL Audit Readiness FAQs
Crucial insights for Quality Managers facing upcoming surveillance, desktop, or on-site assessments.
Pass Your Upcoming NABL Assessment with Total Confidence
Download the 8-page printable checklist for your walk-through, or discover how ExactLIMS automates calibration tracking, ULR sequential numbering, and Levey-Jennings charts natively.