★ Medical Labs

NABL Accreditation (ISO 15189 Medical Labs)

NABL accreditation for medical testing laboratories under ISO 15189.

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Overview of NABL Accreditation (ISO 15189 Medical Labs)

ISO 15189 is the international standard for medical laboratories, and NABL accreditation against it is the accepted proof of technical competence in India. Hospitals, insurers and corporate clients increasingly insist on accredited reports for pathology and diagnostic services.

Key Benefits for Your Business

  • Accredited reports accepted by hospitals and insurers
  • Documented method validation and verification
  • Internal QC, EQAS and measurement traceability
  • Competent staff with defined training and authorisation
  • Faster empanelment with corporate and government clients

Industries We Support

pathology labs, diagnostic chains, hospital laboratories, radiology centres and molecular testing labs and more. Our team will tailor the documentation to your operations.

Documents You Will Need

  • Laboratory registration and scope of tests
  • Quality manual, SOPs and test methods
  • Equipment calibration and maintenance records
  • Internal QC, EQAS and validation records
  • Personnel qualification and competency records

How the Certification Works with SR Certifications

  1. 🔍 Free Gap AnalysisOur auditors review your current processes and identify what is needed to meet the standard.
  2. 📄 Documentation & ImplementationPolicies, manuals, SOPs and formats are prepared and implemented with your team.
  3. 🎓 Awareness TrainingManagement and staff training builds understanding of the new system and their roles.
  4. ✅ Internal Audit & Corrective ActionA practice audit is conducted and findings are closed before the certification audit.
  5. 🏆 Certification Audit & CertificateThe accredited registrar audits your site and the certificate is issued and validated.

Frequently Asked Questions

What is the difference between NABL and NABH?

NABL accredits laboratories for technical competence, while NABH accredits healthcare organisations for quality of care and patient safety.

How long does NABL accreditation take?

A well-prepared medical laboratory typically completes implementation and the assessment process in six to nine months.

Is EQAS participation mandatory?

Yes. NABL requires participation in external quality assessment schemes for accredited test scopes.

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