ISO 15189:2022 · NABL readiness · Medical laboratories

Know exactly where your laboratory stands — before the assessor arrives.

Vayden Accreditation Services prepares medical laboratories for NABL (ISO 15189:2022) accreditation, surveillance and reaccreditation — a systematic, evidence-traced review of your quality management system, delivered as a clear, prioritised path to assessment readiness.

Pathologist-led. Every review is conducted personally by a doctor trained as an ISO 15189:2022 lead auditor. Trusted by laboratories from NABL-accredited hospital labs to first-time applicants — engagements under way across three states.

We get laboratories ready to pass — we are not NABL. Think of us as the coach and the mock exam, before the real assessment.

Services

Four ways we get your laboratory assessment-ready

From a first readiness review to a full quality-management build — each engagement is scoped to exactly where your laboratory is on its accreditation journey.

01

Accreditation Readiness Review

A complete, clause-by-clause evaluation of your documents and records against ISO 15189:2022 / NABL 112. Every applicable requirement is checked; every finding is traced to the specific document or record behind it; the result is a prioritised remediation roadmap — not a pile of observations.

For: first-time applicants · surveillance & reaccreditation preparation
02

Documentation & Gap Closure

Customised controlled documents prepared from Vayden's library of 100+ ISO 15189:2022 templates — quality manual, quality-system procedures, department SOPs across biochemistry, haematology, microbiology and histopathology, and 35+ forms and registers — each tailored to your laboratory and delivered as drafts for your own review, approval and release.

For: laboratories with specific documentation gaps found in review
03

Full QMS Build

The complete documentation system — 100+ structured, numbered, release-ready documents — for a laboratory beginning its accreditation journey, built around your scope, equipment, test menu and staff.

For: new laboratories preparing a first NABL application
04

Continuous Readiness

Stay assessment-ready year-round: periodic re-reviews, document-control upkeep and a surveillance-preparation calendar, with a standing quality partner your quality manager can call.

For: accredited laboratories between assessment cycles
How an engagement runs

A clear path, from first call to closed gaps

1
Discovery call20 minutes — your scope, timeline and concerns.
2
DocumentsYou share what you choose, through a secure channel.
3
Expert reviewSystematic evaluation, personally validated by the auditor.
4
Report & walkthroughA signed report and a live findings session.
5
RemediationClose the gaps yourself, or with Vayden.

Reviews are conducted remotely from your documents and records; the findings walkthrough is held by video call or on-site at your laboratory. Laboratories across India are served.

The methodology

The Vayden Accreditation Readiness Framework

Every review is conducted using a structured, proprietary methodology that evaluates a laboratory's quality management system against all applicable requirements of ISO 15189:2022 and NABL 112. Every requirement is assessed, every finding is traced to specific documentary or record evidence, and every conclusion is reproducible and consistent from one engagement to the next — and personally signed by the lead auditor.

The framework has been validated retrospectively against real NABL assessment outcomes — its findings compared, item by item, with the non-conformities actually raised by assessors in a real laboratory's assessment. It is deliberately honest about its boundaries: it separates records that are merely not yet provided from documents that need attention, and it never claims to predict or replace the assessor's judgment.

What every client receives

  • Accreditation Readiness Report — signed by the reviewing lead auditor
  • Clause-by-clause gap analysis (ISO 15189:2022 / NABL 112)
  • Severity-ranked risk summary
  • Prioritised remediation roadmap, with effort estimates
  • Records checklist — exactly what to prepare before assessment
  • Live findings walkthrough (45–60 minutes) with the auditor
  • One-page executive summary for the laboratory director
  • Optional: customised controlled-document drafts
Why laboratories choose Vayden

The difference is who reviews you, and how

Pathologist-led. Your QMS is reviewed by a doctor who understands laboratory practice — bench to bench, not binder to binder.
Complete by design. Every applicable requirement is evaluated on every engagement. Nothing is skipped, and nothing depends on memory.
Evidence-traced. Every finding cites the document or record behind it, so your team can act on it immediately — and defend it confidently.
Honest boundaries. We separate "not yet provided" from "needs attention", we do not inflate findings, and we never promise certification outcomes.
Confidential by default. Your documents remain within India, are seen only by the reviewing auditor, and are deleted on request after the engagement.
About

Conducted by a peer, not a generalist consultant

V

Dr. Vishal Tayade

MBBS, MD (Pathology) · Founder & Reviewing Auditor

Trained Lead Auditor, ISO 15189:2022 & ISO 19011 — Foundation for Quality (India), an organisational member of the Quality Council of India. A practising pathologist, so your review is conducted by someone who works in the laboratory world and understands what an assessor is really looking for.

Now open — serving laboratories across India

Laboratories are already on the journey with us.

Vayden is open for engagements, and the work is under way across three states: an NABL-accredited hospital laboratory preparing for its next assessment cycle, a document review for a senior institutional quality professional, and a new multi-department diagnostic centre building its quality management system from the ground up.

You will not find client names on this page — confidentiality is the basis of every engagement, including yours.

Book your readiness review
Get in touch

Start with a 20-minute call

Tell us a little about your laboratory and where you are on the accreditation journey. We'll take it from there.

Call / WhatsApp
+91 90822 85186
Based in
Mumbai, Maharashtra — serving laboratories across India
We reply within one working day. Your details are used only to respond to your enquiry.