Top 10 Reasons Labs Fail NABL Assessment — And How to Avoid Them

After working with 25+ labs through the NABL assessment process, Ease Care Consultancy has identified the most common reasons labs receive major non-conformances or have their accreditation delayed.

Understanding these pitfalls before your assessment can save months of delay and thousands of rupees in repeat assessment fees.

1. Incomplete or Inconsistent Documentation

The most common reason for assessment failure. Labs often have SOPs that don’t match actual practice, outdated quality manuals, or missing records. NABL assessors cross-check your documentation against what they observe on the floor. Any gap is a non-conformance.

Fix: Conduct a thorough documentation audit 3 months before your assessment. Ensure every SOP has been reviewed within 2 years, is signed by the current lab director, and reflects current practice.

2. Inadequate Internal Quality Control (IQC)

Many labs run IQC without properly applying Westgard rules, documenting failures, or initiating corrective actions. NABL assessors specifically check IQC records and Levey-Jennings charts.

Fix: Implement a structured IQC review process. Every out-of-control result must be documented with investigation and corrective action. Run two-level IQC for all quantitative tests daily.

3. Missing or Inadequate Competency Assessment

ISO 15189:2022 requires documented competency assessment for every person performing testing. Labs often have training records but lack formal competency evaluations with defined criteria.

Fix: Create a competency assessment SOP. For each staff member, document: direct observation, blind sample testing results, Q&A assessment, and annual competency re-evaluation.

4. Equipment Calibration Not Traceable to National Standards

Calibration certificates that don’t show traceability to NABL-accredited reference standards are a major non-conformance. Many labs use calibration services from non-accredited vendors.

Fix: Only use NABL-accredited calibration laboratories. Verify that calibration certificates clearly show the traceability chain. Keep all calibration records organised and accessible.

5. EQA Non-Participation or Poor Performance

NABL requires participation in External Quality Assessment (EQA/Proficiency Testing) programs. Labs that participate but don’t analyse and respond to poor EQA results face major NCs.

Fix: Enrol in a recognised EQA program (EQAS from CMC Vellore, AIIMS EQA, or CAP). Document your review of each EQA report and initiate corrective action for any unacceptable results.

6. No Formal Sample Rejection Policy

Rejecting unsuitable samples (haemolysed, insufficient volume, wrong container) must be formally documented. Assessors check rejection logs and look for systematic recording.

Fix: Implement a sample acceptance and rejection SOP. Log all rejections with reason, date, referring source, and action taken. Review monthly.

7. Critical Value Notification Without Documentation

ISO 15189:2022 requires documented critical value notification with read-back verification. Many labs notify verbally but don’t document the communication, the recipient’s name, or the read-back.

Fix: Create a critical value register. For every critical result, document: time of notification, person notified (name and designation), read-back confirmation, and the notifying lab staff name.

8. Measurement Uncertainty Not Calculated

Under ISO 15189:2022, measurement uncertainty must be calculated for all quantitative tests. This remains one of the weakest areas in most Indian labs.

Fix: Use the IQC-based approach to calculate MU. Document the sources of uncertainty, calculation method, and expanded uncertainty (U) for each quantitative test. Review annually.

9. No Risk Register or Risk Assessment Process

ISO 15189:2022 explicitly requires a risk-based approach to quality management. Many labs have no formal risk register or risk assessment documentation.

Fix: Create a risk register covering all major lab processes (pre-analytical, analytical, post-analytical). For each risk, document: likelihood, impact, current controls, and additional actions. Review quarterly.

10. Staff Unaware of Quality Policy and Objectives

During assessments, NABL assessors routinely ask staff members about the lab’s quality policy and objectives. If staff cannot articulate these, it signals the QMS is not embedded in lab culture.

Fix: Display the quality policy prominently. Conduct quarterly awareness sessions. Include quality policy in the staff orientation for all new joiners.