Back in 2018, I ran a pathology lab in Pune. Our team was confident—we had top-tier equipment, well-qualified staff, and solid test outcomes. So, when we applied for NABL accreditation, we thought it’d be a cakewalk.
Wrong.
Our application bounced back. Twice. The audit was a disaster. We received 17 non-conformities.
It wasn’t because our lab was bad. It was because we didn’t understand the process.
That’s when I realized that NABL isn’t about capability—it’s about proving capability in a very structured, standard-compliant way.
Fast forward to today—at Prgenix, we’ve helped over 100+ Indian labs become NABL-accredited through full-spectrum process support. This post is everything I wish I had when I first applied.
Why NABL Accreditation Process Support is a Game-Changer?
1.1 The Standard Isn’t the Problem—Interpretation Is
Let’s be clear: ISO/IEC 17025, 15189, and 17020 are not flexible guidelines—they’re strict standards. And NABL assessors evaluate your lab’s every move against those clauses.
Without proper interpretation, labs:
- Misunderstand requirements
- Submit incomplete or non-conforming documentation
- Fail to present evidence correctly
- Delay accreditation by 6–12 months
A process support partner like Prgenix bridges this knowledge gap.
1.2 Process Fatigue = Staff Burnout
We’ve seen teams burn out trying to manage operations and accreditation at the same time. Staff get overwhelmed with:
- Preparing SOPs
- Handling mock audits
- Filing CAR responses
- Learning ISO clauses from scratch
Our process support offloads the burden from your internal team.
1.3 Accreditation Delays Cost Money
For every month you’re not accredited:
- You lose government tenders
- You miss out on insurance partnerships
- You lack trust signals in B2B markets
With expert support, labs cut average accreditation time from 9–12 months to just 3–4 months.
The Step-by-Step Breakdown of NABL Process Support by Prgenix
Step 1: Scope Finalization & Readiness Review
We start with a preliminary audit of your lab, mapping:
- Test scope
- Available infrastructure
- Equipment calibration status
- Personnel qualification
- Internal documentation
Then we match your lab’s needs with the right NABL standard:
- ISO/IEC 17025 for Testing/Calibration
- ISO 15189 for Medical Labs
- ISO/IEC 17020 for Inspection Bodies
Personal Insight: One client thought they needed 15189, but after scope alignment, it turned out 17025 was a better fit. Saved 3 months of rework.
Step 2: QMS Documentation & Control
We create:
- A tailor-made Quality Manual
- SOPs for every test parameter
- Document control systems
- Records for calibration, maintenance, traceability
Each document is:
- Aligned with the exact ISO standard
- Audit-ready
- In a format acceptable to NABL reviewers
Step 3: Internal Audit + Management Review
Before NABL assessors walk in, your lab must:
- Conduct internal audits
- Review non-conformities
- Conduct a management review meeting
- Document preventive/corrective actions
We handle:
- Audit checklist creation
- Auditor training
- Templates for audit reports & meeting MOMs
Step 4: Application Filing & NABL Liaison
We submit:
- NABL 100 form (A or B)
- All annexures
- Scope of testing
- Quality and technical documentation
We handle communications, schedule your assessments, and respond to NABL queries.
Step 5: Pre-Audit Simulation + Staff Training
We conduct a mock assessment:
- Simulates actual NABL audit
- Interviews with key staff
- Testing of SOP implementation
- Evidence walkthrough drills
Staff are coached on:
- Answering auditor queries
- Document referencing
- Handling non-conformities gracefully
Advanced Tips to Nail NABL Accreditation Faster
✅ Tip 1: Start With What You Have—Not What You Think You Need
Labs often delay applications waiting for “perfect conditions.” Start now. Our process support helps upgrade your lab as we go.
✅ Tip 2: Don’t Over-Scope
More scope = more scrutiny = higher failure risk. Begin with core services, then expand after initial accreditation.
✅ Tip 3: Train Everyone (Not Just the Lab Head)
We ensure even housekeeping staff understand sample handling protocols. Everyone’s role matters during assessment.
✅ Tip 4: Track Every Calibration
NABL assessors love traceability. We implement a calibration tracker system that flags missed deadlines before the audit does.
✅ Tip 5: Keep an Audit Calendar
Surveillance audits happen every 12–18 months. We help labs stay compliant year-round with automated QMS reminders and follow-ups.
Case Study: From Rejection to Recognition in Just 62 Days
Client: Environmental Testing Lab, Hyderabad
Challenge: Application rejected previously due to documentation gaps
What Prgenix Did:
- Rewrote 100+ pages of SOPs
- Installed a real-time calibration tracker
- Conducted 2 mock audits and staff drills
- Filed CARs within 72 hours of NCR issuance
Results:
- NABL-accredited in 62 days
- Gained approval for 6 pollution control board tenders
- Monthly revenue grew by 55% in 90 days
FAQs: People Also Ask
Q1. What is NABL accreditation process support?
It’s professional, end-to-end assistance in helping labs meet NABL’s ISO-based requirements—covering documentation, audits, training, and post-certification support.
Q2. How long does the NABL process take with proper support?
With expert help, most labs are accredited in 60–90 working days. Without support, delays can stretch beyond 9–12 months.
Q3. Can we apply directly without a consultant?
Yes, but most self-applied labs face documentation issues, fail mock audits, and experience rejections. Process support increases first-time success rates significantly.
Q4. What kind of labs does Prgenix support?
We’ve worked with:
- Pathology labs
- Calibration labs
- Environmental labs
- Food testing labs
- Pharma quality units
- Inspection bodies under 17020
Q5. What happens after NABL accreditation?
We offer:
- Scope expansion support
- Surveillance audit readiness
- SOP updates for standard revisions
- Internal audit outsourcing
- Compliance training for new staff
Don’t Let the Process Stop You
The NABL process isn’t easy—but it doesn’t have to be painful.
With the right support, you move faster, avoid audit shocks, and turn accreditation into a strategic advantage, not a regulatory checkbox.
At Prgenix, we’ve helped over 100 labs navigate this journey—and we’re ready to help yours next.
FREE NABL READINESS AUDIT