Applicable technical framework
ISO 15189:2022 specifies medical laboratory quality and competence requirements. Use the current NABL criteria and document versions for the actual application. [1][4]
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NABL laboratory quality
Build confidence in every result.
Medical laboratory quality and competence support for ISO 15189:2022 and applicable NABL criteria.
Official references reviewed 19 October 2026 · India
UNDERSTAND THE SERVICEA clear scope.
A clear scope.
An informed next step.
This service addresses laboratory quality and competence for a defined test scope. It does not confer hospital-wide NABH accreditation.
WHY YOUR HOSPITAL NEEDS THIS WORKING PARTNERSHIP
Connect laboratory readiness with reliable service delivery.
We coordinate the agreed laboratory quality workplan with qualified technical specialists and hospital management, keeping scope, responsibilities and evidence visible.
FINANCIAL BENEFITS FOR YOUR HOSPITALRevenue opportunities.
Revenue opportunities.
Stronger financial discipline.
Position the hospital laboratory for eligible testing relationships and stronger cost control within its approved test scope.
- Approach institutional and healthcare buyers that require accreditation for the relevant tests.
- Support professional referrals by clearly presenting the laboratory’s assessed capabilities.
- Review sample rejection, reagent control and technical rework to address avoidable costs.
- Assess whether the proposed work fits laboratory capacity and commercially viable service terms.
Accreditation applies to the approved scope. Testing contracts, referrals, prices and financial results depend on the buyer, demand and actual delivery costs.
01 / APPLICABLE FRAMEWORKGovernment &
Government &
regulatory position.
The requirement depends on the programme, state, services and workforce model. References below support the regulatory overview; confirm the current notice and facility-specific applicability before applying.
Define the application scope
NABL identifies NABL 153 as the medical laboratory application form and provides an online application route. Scope, system documents and supporting evidence must match the laboratory. [2]
Independent review
Follow NABL’s applicable document review, assessment, corrective-action and decision process. The laboratory remains responsible for its technical competence. [3]
02 / VALUE FOR THE HOSPITALWhat stronger
01 02 03 04 05 06
What stronger
systems can support.
Recognition of laboratory competence
Accreditation recognises competence within the approved examination scope.
Confidence in laboratory reports
Assessed technical and quality systems support confidence in laboratory results.
Traceable examination workflows
Sample, method, equipment and reporting records support investigation and review.
Stronger technical controls
Quality-control and external-assessment activities help identify technical performance issues.
Visible capability for clinicians
An accurate accredited scope helps clinicians and partners understand demonstrated laboratory services.
Continuous laboratory improvement
Audits, competence reviews and corrective actions support ongoing performance management.
Potential operational benefits depend on implementation and the hospital’s circumstances. No approval, saving, patient volume or payment outcome is guaranteed.
03 / PREPARE YOUR EVIDENCEDocuments
Documents
to organise.
This is a preparation checklist. The official application or a facility-specific compliance review may require additional items. Keep patient records, worker identity documents and bank details out of the website enquiry form.
- Legal identity, laboratory registration and service/location profile
- Proposed disciplines, tests, methods and examination scope
- Technical staff qualifications, experience, authorisation and competency evidence
- Quality system documents and sample-management procedures
- Equipment inventory, maintenance, calibration and method verification/validation evidence
- Internal quality control and EQA/PT plans/results as applicable
- Audit reports, management reviews, risks, nonconforming work and corrective actions
04 / FROM DISCUSSION TO DELIVERYYour step-by-step
Your step-by-step
working plan.
Suggested hospital and consulting workflow. Official assessment, inspection and decision stages follow the selected authority’s current process.
- 01
Scope the laboratory
Confirm disciplines, methods, tests, locations and responsible technical personnel.
- 02
Review technical gaps
Use a qualified laboratory expert to assess staff, environment, equipment and examination workflows.
- 03
Build the quality system
Control documents and records; implement sample acceptance, result review, complaint and nonconformity processes.
- 04
Validate implementation
Organise method evidence, quality controls, EQA/PT and traceability appropriate to the scope.
- 05
Audit and apply
Complete internal review, verify actions and support the authorised laboratory application and official payments.
- 06
Address assessment findings
Coordinate authentic evidence and technical responses to observations, with laboratory sign-off.
- 07
Sustain the approved scope
Use the formal decision and scope correctly; track changes, ongoing quality activities and reassessment obligations.
WHAT COMPLETION MEANS
Accreditation is evidenced by NABL’s formal decision and approved scope. The project handover identifies continuing technical actions and review dates.
Know who
owns each action.
Your responsibilities
- Provide a qualified technical lead and competent authorised staff.
- Own examination methods, results, patient records and technical decisions.
- Fund equipment, calibration, EQA/PT and other laboratory requirements.
CareAxis support
- Scope review, technical gap plan and quality-system implementation support.
- Evidence organisation, audit coordination and application assistance.
- Technical specialists assigned according to the agreed disciplines.
View the complete service deliverables
- Test scope and technical gap assessment
- Quality system and document control
- Method verification and validation planning
- Internal quality control and EQA/PT planning
- Equipment traceability and competence records
- Internal audit, management review and NC closure
Delivered with a qualified laboratory technical specialist. Accreditation covers the approved scope of tests; it is not a blanket certificate for the hospital.
Costs, timing
and common pitfalls.
Dependent on scope, technical gaps and evidence maturity
Price by disciplines, tests, locations, technical maturity and visits. Official fees, reference materials, equipment work, calibration and EQA/PT are separate unless expressly included. Duration depends on implementation evidence and NABL scheduling.
Request a scoped proposal07 / CHECK THE ORIGINAL REQUIREMENTSOfficial
Official
reference desk.
- ISO 15189:2022 - Medical laboratories
- NABL official FAQs and medical laboratory application route
- NABL accreditation process and scope
- NABL current accreditation documents
- NABL official benefits of accreditation
Reference review: 19 October 2026. Official bodies may amend criteria, rules, fees and portals. Some sources are standing guidance and must be read with subsequent notifications. Consulting workflow and suggested hospital benefits are CareAxis planning guidance, not government approval or an official checklist.
A stronger association.
A clearer way forward.
Discuss your hospital’s priorities Connect financial priorities, people and hospital systems through an agreed working relationship.