NABL Consultancy for Medical Laboratories
We prepare pathology and diagnostic laboratories for NABL accreditation as per ISO 15189:2022: gap analysis, documents, IQC and EQA, staff training and a mock assessment, then support on assessment day and after. Most labs are ready for assessment in about 90 days.
- Granted by
- NABL, Quality Council of India
- Standard
- ISO 15189:2022 and NABL 112A
Included with every engagement
- A full internal audit by our experts, at no extra cost
- A dedicated Quality Manager beside you on assessment day
- Every document handed over digitally, ready to use
- Labs & hospitals
- 150+
- States covered
- 16+
- Customer satisfaction
- 96%
Company data as of Oct. 26
Who needs NABL consultancy
For most medical laboratories in India, NABL accreditation is a choice rather than a legal requirement, but referring doctors, hospitals, corporate clients, insurers and many health schemes look for it. These are the laboratories that come to us.
Laboratories applying for the first time
Pathology laboratories and diagnostic centres that have never been assessed, and want a clear plan from gap analysis to assessment day rather than learning ISO 15189:2022 by trial and error.
Laboratories in hospitals
A hospital laboratory is accredited by NABL separately from the hospital. If the hospital is also preparing for NABH, we look at both and recommend where to start.
Labs without a full-time quality expert
Smaller laboratories where the person responsible for quality also works at the bench. We train and support that person, and our team does the heavy lifting on documents and audits.
Labs that need accreditation for tie-ups
Laboratories that want to work with hospitals, corporate clients, insurers or government health schemes, many of which ask for NABL accreditation.
Accredited labs facing a visit
Laboratories with a surveillance visit or reassessment coming up, or open non-conformities to close, that want their system checked before the assessors arrive.
What our NABL consultancy covers
Implementation support from the first gap analysis to your surveillance visits: this is what our team does for your laboratory, with your staff rather than around them.
ForPathology laboratories · Diagnostic centres · Laboratories in hospitals
Gap analysis against ISO 15189:2022
Our experts review your systems, documents and records, interview staff and check your infrastructure, then give you a prioritised action plan.
Quality manual, SOPs and forms
Drafted for your laboratory by our team and handed over digitally, ready to use.
IQC and EQA set up with you
Internal quality control and proficiency testing in place, the way NABL expects to see them.
Hands-on staff training
Your team trained on ISO 15189:2022 and NABL requirements by our expert trainers.
Internal audit and mock assessment
A full internal audit at no extra cost, and a mock assessment run the way an NABL assessor would.
Assessment day and after
A dedicated Quality Manager beside you on the day, help closing every non-conformity, and support for surveillance visits and reassessment.
Documentation and quality management
NABL assessors judge a laboratory on its records as much as its procedures: a document only counts if the work follows it and the records show it. We write the documents with your staff, then help you run the quality system they describe until it is routine.
Documents and records we prepare with you
- Quality manual, quality policy and quality objectives
- SOPs for the pre-examination, examination and post-examination processes, from test request and sample collection to the final report
- Document control: a master list, version numbers, review dates and approvals
- IQC records and Levey-Jennings charts, and EQA or proficiency testing records with your review of each cycle
- Method verification records, such as precision, linearity and carryover studies, and measurement uncertainty estimates
- Equipment, calibration and maintenance records, with metrological traceability
- Staff qualification, training, authorisation and competence records
- Risk, impartiality and confidentiality records
- Internal audit, management review, complaint, non-conformity and corrective action records
Making the system work day to day
- IQC reviewed every run against your control rules, with the action recorded when a run fails
- Every EQA report reviewed, with corrective action when a result is unacceptable
- An internal audit programme that covers every clause and every section of the laboratory
- Management review with the inputs ISO 15189:2022 lists, and actions with owners and deadlines
- Competence assessed for every member of staff at the intervals your procedures set
- Documents reviewed on schedule, so SOPs keep matching what staff actually do
ISO 15189:2022 implementation for NABL
NABL accredits medical laboratories against ISO 15189:2022, the international standard for quality and competence in medical laboratories, together with its own specific criteria. Putting the standard into practice in your laboratory is most of the work of getting accredited.
The 2022 edition replaced ISO 15189:2012. It arranges the requirements in clauses 4 to 8, makes risk management and impartiality explicit, and includes the requirements for point-of-care testing that used to sit in a separate standard, ISO 22870.
We implement it clause by clause, so that by assessment day each requirement has a working process and the records to show it.
Clauses 4 and 5
General requirements, such as impartiality and confidentiality, and structure and governance.
Clause 6
Resources: personnel competence, equipment, facilities and externally provided services.
Clause 7
Processes: pre-examination, examination and post-examination, from request to report.
Clause 8
The management system: document control, risk, internal audit and management review.
The NABL accreditation process, step by step
- Granted by
- NABL, Quality Council of India
- Standard
- ISO 15189:2022 and NABL 112A
What NABL asks for
Step 1: Build your quality system
Quality manual, SOPs, IQC, proficiency testing, internal audit and management review in place.
How we help
We write your documents, set up IQC and proficiency testing, and train your staff.
Step 2: Apply
Submit your scope of tests and documents on the NABL portal. NABL reviews them.
How we help
By this stage our team has written and reviewed your documents with you.
Step 3: On-site assessment
Assessors check records, watch tests being run and interview staff.
How we help
We run a mock assessment first, and stay with your team on the day.
Step 4: Close non-conformities
Send corrective actions, with evidence, by NABL's deadline.
How we help
We write them with you.
Step 5: Accreditation
Granted for a fixed cycle, with surveillance visits in between and a reassessment before it expires.
How we help
We prepare you for every surveillance visit and reassessment.
Free NABL consultation
Get a timeline for your organisation, or our step-by-step roadmap.
Common challenges in NABL preparation
Most findings at NABL assessments come from the same few places. We plan for them from the gap analysis onwards.
Documents that don't match practice
SOPs adapted from templates describe a different laboratory, or were not updated after a change of analyser or method. Assessors compare the SOP with what they see at the bench.
We write your documents around your own workflow and equipment, and go through each one with the staff who use it.
Gaps in IQC and EQA records
Controls are run but not plotted, rule violations have no recorded action, or EQA reports are filed without anyone reviewing them.
We set up IQC and EQA with you, including who reviews what and how each action is recorded.
Method verification and measurement uncertainty
Analysers already in use have no verification records, or quantitative tests have no measurement uncertainty estimates.
We plan the verification studies and uncertainty estimates with you; our free calculators work out precision, linearity and carryover.
Calibration and equipment records
Missing calibration certificates, overdue maintenance or no traceability, often for small equipment such as pipettes, thermometers and centrifuges.
The gap analysis checks your equipment records, so missing calibrations are found and fixed before assessment day.
Staff who can't explain the system
Assessors interview bench staff, not only the quality team: what they do when IQC fails, how a sample is rejected, how a critical result is reported.
Hands-on training for your team, then a mock assessment with the same kind of questions.
Internal audits done as a formality
A rushed internal audit misses the non-conformities the assessor then finds.
Our experts run a full internal audit, at no extra cost, the way an NABL assessor would.
Letting the system slip after accreditation
Once the certificate arrives, document reviews, training and audits fall behind, and the next surveillance visit finds the gaps.
We prepare you for every surveillance visit and reassessment.
Read more: common challenges in maintaining NABL accreditation
What laboratory owners say
“We got quotes from many places for NABL, but Qualityveda felt the most professional and affordable. Their work speaks louder than their words.”
Dr. Raj KumarDirector at Rajmit Healthcare, Delhi “As a lab owner, I always worried about quality compliance. Qualityveda works like an extended team - regular visits, proper documentation, and always available when needed.”
Dr. Anil GaurDirector at Friends X-Ray Centre, Delhi
NABL consultancy: common questions
How much does NABL consultancy cost?
It depends on the size of your laboratory: the number of departments, tests and sites. After your free consultation, we share the full price up front, with internal audits included at no extra cost.
How long does NABL accreditation take?
Most labs are ready for assessment in about 90 days, from the gap analysis to the assessment visit. Your free roadmap sets out your exact timeline.
Does Qualityveda grant NABL accreditation?
No. Accreditation is granted only by NABL, a constituent board of the Quality Council of India, after its own assessment of your laboratory. We prepare your laboratory and your team for that assessment and support you through it.
What is the difference between ISO 15189 and NABL accreditation?
ISO 15189:2022 is the international standard for quality and competence in medical laboratories. NABL is the body in India that assesses medical laboratories against it, along with its own specific criteria, and grants accreditation.
What do we need in place before we apply to NABL?
A working quality system with records that show it has been running: documents and SOPs in use, IQC and proficiency testing records, an internal audit and a management review. You then submit your scope of tests and your documents on the NABL portal, and NABL reviews them before the on-site assessment.
Do we have to include every test in our NABL scope?
No. You apply for a defined scope of tests, and NABL accredits only those. Many laboratories start with the tests they run most and have the strongest IQC and proficiency testing records for. In your free consultation we help you decide what to put forward first.
Do we need measurement uncertainty for our tests?
For quantitative tests, yes. ISO 15189:2022 asks laboratories to evaluate the measurement uncertainty of measured values where it is relevant, and to keep those estimates under review. We help you work out the estimates and record them for the tests in your scope.
Do you work on-site or remotely?
Both. Our experts visit your lab or hospital for key stages such as the gap analysis and the internal audit, and support you remotely in between. Training runs as live online sessions.
Do we still need our own quality manager?
Yes, in practice. ISO 15189:2022 no longer uses the title "quality manager", but it still requires people in your organisation with the authority to implement, maintain and improve the management system, and assessors expect to meet them. We train and support that person, and a dedicated Quality Manager from our team stands beside you during audits.
What happens if the assessor finds non-conformities?
We help you write the corrective actions, gather the evidence and close every non-conformity, so nothing holds up your accreditation.
Can you help us stay accredited?
Yes. We prepare you for every surveillance visit and for reaccreditation, so you stay accredited year after year.
Which states do you work in?
We work with labs and hospitals in 16+ states across India, including Delhi, Uttar Pradesh, Haryana, Rajasthan, Madhya Pradesh, Gujarat, Bihar, Andhra Pradesh and Goa.
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