I’ll never forget the moment my pathology lab’s NABL application was rejected—after 9 months of effort and ₹2.2 lakhs spent.
The problem? Our documentation was off. Staff weren’t trained. And our QMS? A Frankenstein of copied SOPs.
That rejection hit hard. But it also pushed me to find a real solution. Enter: NABL certification consultancy.
With professional help, I restructured everything. We got certified in 73 days.
Now, through Prgenix, I help other labs skip the mess and get it right—the first time.
If you’re wondering whether NABL certification consultants are worth it, or how to choose one, this guide lays it all out.
Why NABL Certification Consultancy Matters?
1.1 NABL Isn’t a Formality—It’s a System
Most lab owners think NABL certification is a checklist. It’s not. It’s a robust Quality Management System (QMS) based on standards like:
- ISO/IEC 17025:2017 (Testing/Calibration)
- ISO 15189:2022 (Medical)
- ISO/IEC 17020 (Inspection bodies)
Getting certified isn’t just about documents—it’s about aligning your people, processes, and infrastructure with global standards.
And that’s where a consultancy changes the game.
1.2 The Hidden Costs of Doing It Alone
Every failed audit delays your certification. For every 60-day delay, most labs lose:
- At least 3 B2B clients
- ₹1–3 lakhs in potential revenue
- Government or hospital tender eligibility
Without expert support, you risk:
- Audit rejections
- Non-conformities (NCRs)
- Incomplete documentation
- Failed staff assessments
A consultancy doesn’t just help you “get accredited”—they help you avoid burning cash while trying.
1.3 Prgenix’s Role as Your NABL Navigator
At Prgenix, we offer end-to-end NABL consultancy services:
- Gap analysis
- Documentation from scratch
- SOP customization
- Mock audits
- Liaisoning with NABL team
- Post-certification support
Our team includes former NABL assessors, ISO auditors, and QMS experts—because no lab deserves to drown in jargon or bureaucracy.
Step-by-Step Breakdown – How NABL Certification Consultancy Works?
Step 1: Initial Lab Evaluation (Gap Analysis)
We physically visit your lab to audit:
- Personnel qualifications
- Equipment calibration
- Test method validation
- Documentation gaps
- Internal audit readiness
This becomes your custom “Accreditation Roadmap.”
Step 2: QMS Documentation & Training
We create:
- Quality Manual
- 15–30 SOPs based on your scope
- Record formats & calibration logs
- Internal audit schedule
- CAPA process docs
Our trainers then educate your staff in:
- ISO clauses
- Equipment traceability
- Sample handling
- Customer complaints
- Assessment simulations
Personal Story: We once trained 14 people from a microbiology lab using bilingual modules (Hindi + English), making ISO 17025 digestible for everyone—from junior techs to PhD leads.
Step 3: Mock Audit & Readiness Check
Before NABL’s actual assessment:
- We simulate the full audit
- Coach key personnel for interviews
- Identify & fix last-minute red flags
- Perform document trace exercises
Step 4: Application Filing and Support
We handle:
- NABL portal upload
- Form NABL 100A/B filing
- Document indexing
- CAR (Corrective Action Report) writing
- Post-assessment support
If issues arise during review, our team liaises directly with NABL assessors for clarification and corrections.
Pro Tips to Maximize Value from Your NABL Consultant
✅ Don’t Hide Problems—Expose Them Early
Transparency helps us help you. Be honest about:
- Missing SOPs
- Old equipment
- Untrained staff
- Skipped internal audits
The earlier we know, the faster we fix.
✅ Insist on Customization
If your consultant is giving you “copy-paste” ISO docs, run.
At Prgenix, no two labs get the same QMS pack. We customize SOPs to your instruments, sample volume, and staff roles.
✅ Think Beyond Certification
Post-certification services matter:
- Expansion of scope
- Surveillance audits (every 2 years)
- Corrective action response to non-conformities
- Internal audit refreshers
A good consultant plans for your long game.
Case Study: How a Tier-2 Hospital Lab Got NABL Certified in 74 Days?
Client: 75-bed private hospital lab in Bhopal
Challenge: No QMS, uncalibrated equipment, high sample volume
What We Did:
- Created ISO 15189-ready SOPs from scratch
- Conducted bilingual staff training in 3 phases
- Audited 17 instruments for calibration traceability
- Filed NABL application with a compliance score of 92%
Results:
- Certified in 74 working days
- Became the only NABL lab in their district
- Won a ₹1.2 crore pathology outsourcing deal with a diagnostic brand
FAQs: People Also Ask
Q1. What is NABL certification consultancy?
It’s a professional service that helps labs prepare, document, and clear the NABL accreditation process, ensuring compliance with ISO standards.
Q2. How much does NABL consultancy cost?
It depends on lab type and scope. Prgenix offers packages from ₹85,000 to ₹2.5 lakhs depending on lab size and standards involved.
Q3. How long does the certification process take with consultancy?
With consultancy, most labs get certified in 60–90 working days. Without help, it often takes 6–12 months or more.
Q4. What is the difference between ISO 17025 and NABL?
ISO 17025 is the standard. NABL is the Indian authority that certifies labs based on that standard. NABL accreditation = ISO 17025 compliance.
Q5. Is Prgenix approved by NABL?
While NABL doesn’t officially endorse consultants, our documentation success rate is 98.3% with over 120+ labs certified in the past 3 years.
Don’t Let Documentation Derail Your Dreams
I’ve been on both sides of the NABL process—first as a frustrated lab owner, then as a successful consultant. And I can tell you one thing:
Trying to “wing it” without guidance costs more—time, money, reputation.
Prgenix’s NABL certification consultancy exists so you never face those hurdles.
GET YOUR NABL LAB AUDIT