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Labs

ISO 15189 Certification —
Medical Laboratories

Prepare your medical laboratory for accreditation with reliable testing, quality control and patient-focused processes.

Timeline3–6 weeks
Validity3 years
Price from[₹ price]
AuditOn-site / remote

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What is ISO 15189?

ISO 15189 sets requirements for quality and competence in medical laboratories. In India, medical labs are accredited to it by NABL.

We help labs build the quality system, internal quality control, external quality assessment and documentation needed for accreditation.

Who needs ISO 15189?

Diagnostic labsHospital labsPathology chains

What you gain

Win more businessCustomers and tenders increasingly ask for this certificate.
Fewer problemsRisks are identified and controlled before they cause losses.
Clear processesEveryone knows what to do, and records prove it.
Customer trustAn internationally recognised mark on your quotes and website.
Legal readinessThe obligations that apply to you, tracked in one place.
Continual improvementRegular audits and reviews keep the system working.

ISO 15189 certification process

  1. 1Free consultation & quoteScope, price and timeline confirmed on the first call.Day 1
  2. 2Gap analysisWe compare your current way of working with ISO 15189 requirements.Week 1
  3. 3DocumentationPolicy, objectives, procedures and record formats made for your business.Week 1–2
  4. 4Training, internal audit & management reviewYour team learns the system; we audit it and close any gaps.Week 2–4
  5. 5Certification audit & certificateAn accredited certification body audits you and issues the certificate.Week 4–6

Documents we prepare for you

  • Policy and objectives
  • Scope and context document
  • Risk assessment and treatment records
  • Procedures and work instructions
  • Formats, registers and checklists
  • Internal audit and review reports

What we need from you

  • Company registration / GST certificate
  • Address of each location
  • List of products or services
  • Organisation chart and staff count
  • One coordinator from your team

ISO 15189 FAQs

01 How long does ISO 15189 certification take?

Most small and mid-size organisations are certified in 3–6 weeks. It depends on your size, locations and how much is already documented.

02 How long is the certificate valid?

Certificates are usually valid for 3 years, with a short surveillance audit each year. We help you prepare for those too.

03 Is the certificate accredited and verifiable?

Yes. Audits are done by accredited certification bodies, and your certificate can be verified online by customers and tender committees.

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Free consultation. Fixed price. Certificate in weeks, not months.

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