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Medical & Clinical Laboratories

NABL ISO 15189 accreditation for medical laboratories

Clinical laboratories carry the weight of diagnosis. ISO 15189 accreditation proves your results are reliable, your processes are controlled, and your team is competent. We prepare you for every clause, from pre-examination to post-examination.

NABLISO 15189Clinical
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20+Years of mastery
200+Accreditations delivered
98%First-attempt success
25+Expert consultants
Who this is for

Built for your kind of organisation

  • Standalone diagnostic and pathology laboratories
  • Multi-discipline clinical laboratories (haematology, biochemistry, microbiology, histopathology, immunology)
  • Hospital-based laboratories
  • Collection-centre networks seeking a common quality system
What we do for you

End-to-end, nothing left to chance

  • Gap analysis against ISO 15189 with a prioritised report
  • Quality manual, SOPs, policies and records written for your scope
  • Method verification, quality control and internal quality assurance set-up
  • Staff training on competence, quality and documentation
  • Internal audit and mock assessment by former NABL assessors
  • On-site support during the official NABL assessment and closure of non-conformities
NABL โ€” ISO 15189

Multi-Discipline Diagnostic Laboratory, Delhi NCR

An 8-discipline clinical laboratory covering haematology, biochemistry, microbiology, histopathology and immunology. NABL accreditation across 200+ test parameters in 14 months from a 38% baseline compliance, first attempt.

Our methodology

Five steps from gap to certificate

01

Gap analysis

Prioritised gap report within 7 working days.

02

Documentation

Manuals, SOPs and records written for your scope.

03

Training

Your team trained to own and sustain the system.

04

Internal audit

Mock assessment by former assessors.

05

Assessment & award

On-site support until the certificate is awarded.

Questions

Frequently asked questions

How long does ISO 15189 accreditation take?

It depends on where you start. Our Delhi NCR diagnostic laboratory project went from a 38% baseline to accreditation in 14 months. After a free consultation we give you a realistic timeline for your laboratory.

Do you only write documents?

No. Documents are one step. We also train your staff, set up quality control, run an internal audit and mock assessment, and support you on the day of the official assessment.

Who awards the accreditation?

NABL (National Accreditation Board for Testing and Calibration Laboratories) awards it after its own assessment. We prepare you for that assessment and support you through it.

Can you help if we failed an earlier assessment?

Yes. Tell us what happened in the consultation form. We will review the non-conformities and show you what has to change.

Ready to start your accreditation?

Book a complimentary 60-minute strategy session. An honest assessment of where you stand and exactly how we will get you there.

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