NABL Accreditation for Medical Laboratories
ISO 15189 — Medical laboratories: requirements for quality and competence
NABL accreditation to ISO 15189 shows that a medical laboratory produces reliable results for patient care. Certsure helps pathology labs, diagnostic centres and hospital laboratories prepare for NABL assessment.
How Certsure helps with NABL (ISO 15189)
Certsure Certification is a consultancy based in Lucknow, working with organisations across India. We help you understand the requirements, close the gaps and get ready for assessment — gap analysis, documentation, implementation support, training, internal audits and support during the external audit. The certificate, licence, registration or report itself is granted by the relevant authority, accreditation board or independent auditor.
Who this is for
- Stand-alone pathology laboratories and diagnostic centres
- Hospital laboratories — often prepared alongside NABH accreditation
- Laboratories in blood centres and public health facilities
- Collection-centre networks that need a consistent pre-examination process
What assessors focus on
- Pre-examination: test requests, patient identification, sample collection, transport, acceptance and rejection criteria
- Examination: method verification/validation, internal quality control, measurement uncertainty and biological reference intervals
- External quality assessment (EQAS) or inter-laboratory comparison for each examination
- Post-examination: result review, critical-result reporting, report format and retention of samples and records
- Risk management and patient safety, personnel competence, equipment, reagents and information systems
How Certsure supports your laboratory
- Decide the first scope of examinations and departments (biochemistry, haematology, microbiology, clinical pathology and others)
- Gap assessment against ISO 15189:2022 and NABL requirements
- Quality manual, SOPs for every examination, and practical formats for QC, EQAS and corrective action
- Training of technicians and pathologists, internal audit and management review
- Application on the NABL portal and support during assessment and closure of findings
Read the NABL accreditation process for laboratories for the full route.
Not sure whether NABL (ISO 15189) is the right fit? Read how to choose the right ISO standard or ask our team.
Benefits of NABL Accreditation for Medical Laboratories
Patient safety
Empanelment and referrals
Reliable results
Doctor and patient trust
Smoother operations
Recognised competence
NABL (ISO 15189) process, step by step
- Define examinations and departments in scope
- Gap assessment against ISO 15189:2022
- Quality manual, SOPs and formats
- IQC, EQAS, uncertainty and reference intervals
- Training, internal audit and management review
- Application on the NABL portal
- Assessment by NABL and closure of findings
- Accreditation decision and yearly surveillance
Timelines depend on your organisation's size, the scope and how much of the system already exists. Read how to prepare for an ISO audit.
Documents typically required
We provide a checklist tailored to your organisation. Commonly needed:
NABL (ISO 15189): frequently asked questions
Which standard applies to medical laboratories?
Can a small pathology lab get NABL accreditation?
Does Certsure issue the accreditation?
What is EQAS and do we need it?
Related services
Helpful guides
Request a free NABL (ISO 15189) consultation
Tell us about your organisation and we'll explain the requirements, timeline and next steps — no obligation.