Molecular Diagnostics, Hospitals & Pathology Labs
Quality Systems
Precision-Built for Your Lab
NABL-NABH · ISO 15189 · CAP-CLIA · ASHI · EFI · EMQN End-to-end quality consulting for diagnostic, pathology and hospital laboratories that demand audit confidence and operational excellence.
Service Domains
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Accreditation Support
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TRUSTED STANDARDS
NABL Accreditation
ISO 15189
CAP Accreditation
Hospital Labs
Molecular Diagnostics
OUR SERVICES
Six domains of
laboratory excellence
From gap assessment through accreditation renewal — we cover every layer of your diagnostic quality system.
Quality Systems & Regulatory Consulting
NABL, ISO 15189 advisory, QMS setup, SOP creation, RCA/CAPA programs, and accreditation renewal support.
Proficiency Testing & QC Readiness
PT preparation, IQC system design, EQA readiness, and data-driven QC monitoring for Molecular Diagnostics, Hospitals & Pathology Labs
Cost-Optimized Lab Design & Setup
Compliance-focused layout planning, workflow optimization, biosafety controls, and molecular lab setup advisory.
Accreditation & Certification Readiness
Clause-by-clause compliance mapping, mock audits, staff training, and documentation restructuring for CAP and ISO.
Internal Audits, RCA & Corrective Actions
Clause-based internal audits, root cause analysis, CAPA frameworks, and customized audit checklist tools.
Scientific & Experimental Project Advisory
Experimental design, assay validation, and molecular test development, with scientific consulting that bridges research, diagnostics, and clinical applications.
WHY CHOOSE QLAXY
Audit-ready labs begin
with the right framework
From first gap analysis to post-accreditation KPI dashboards, we embed quality into every layer of your lab operations.
- NABL & CAP documentation aligned to your lab's exact scale
- Continuous QC monitoring and trend analysis system design
- Structured RCA frameworks that close non-conformities effectively
- Mock audits and virtual assessment simulation support
- End-to-end lab setup and workflow optimization
ACCRED.
Mock Audits
IQC / EQA / PT
SOP & Documentation
QMS Foundation
OUR PROCESS
From Gap to Accreditation
A structured four-phase engagement that turns compliance gaps into certified quality systems.
01
Gap Assessment
Deep-dive laboratory audits to identify compliance gaps against NABL, ISO 15189, and CAP requirements, with focused review of processes.
02
QMS & Documentation
SOPs, Quality Manuals, and document control systems built from scratch, audit-ready and clause-mapped.
03
Mock Audits & Training
Simulation-based mock audits, staff readiness training, and virtual assessment support to prepare your team.
04
Accreditation & Beyond
Final accreditation readiness support, KPI dashboards, and ongoing renewal advisory for sustained compliance.
QLAXY ACADEMY
Building the Next Generation of Lab Quality Leaders
Practical workshops, auditor certification training, and online awareness sessions designed for freshers through senior laboratory professionals.
FREQUENTLY ASKED QUESTIONS
Everything you need to know
about Qlaxy
Have a question not answered here? Reach out for a free consultation and we’ll be happy to help.
What is Qlaxy?
Qlaxy is a Molecular Diagnostics, Hospitals & Pathology Lab quality consulting firm that helps laboratories build audit-ready quality systems, improve operational quality, and prepare for accreditation.
What accreditation standards does Qlaxy support?
Qlaxy provides consulting and accreditation-readiness support for NABL, ISO 15189 and CAP requirements.
Can Qlaxy help a laboratory prepare for NABL accreditation?
A gap assessment is a detailed review of your laboratory’s existing processes, documentation, and quality systems against applicable accreditation requirements. Qlaxy uses this assessment to identify compliance gaps and define the actions required to become audit-ready.
What is a laboratory gap assessment?
Yes. Qlaxy can assess your laboratory’s current compliance, identify gaps, develop or restructure documentation, conduct mock audits, support staff readiness, and help establish a structured path toward accreditation.
Can Qlaxy build a Quality Management System (QMS) from scratch?
Yes. Qlaxy can help develop and restructure SOPs, Quality Manuals, and document-control systems to create consistent, controlled, and audit-ready laboratory documentation.
Does Qlaxy provide SOP and laboratory documentation support?
Yes. Qlaxy supports QMS setup, including Quality Manuals, SOPs, document-control systems, RCA/CAPA frameworks, and clause-mapped documentation designed for accreditation readiness.
Can Qlaxy conduct internal laboratory audits?
Yes. Qlaxy provides clause-based internal audits, customized audit checklists, root cause analysis, and corrective and preventive action (CAPA) support.
Can Qlaxy help with RCA and CAPA?
Yes. Qlaxy helps laboratories identify root causes of non-conformities and establish structured corrective and preventive action frameworks to address and prevent recurring issues.
Does Qlaxy provide proficiency testing and quality-control support?
Yes. Qlaxy supports proficiency testing (PT) participation, internal quality control (IQC) system design, EQA readiness, and data-driven QC monitoring for molecular diagnostic, pathology and hospital laboratories.
Can Qlaxy help design and set up a molecular laboratory?
Yes. Qlaxy provides compliance-focused laboratory layout planning, workflow optimization, biosafety controls, and molecular laboratory setup advisory.
Does Qlaxy support molecular diagnostics laboratories?
Yes. Qlaxy specializes in quality consulting for molecular diagnostics and lab operations, including quality systems, QC, accreditation readiness, laboratory setup, and QA.
Can Qlaxy help laboratories prepare for accreditation audits?
Yes. Qlaxy can assess your laboratory’s current compliance, identify gaps, develop or restructure documentation, conduct mock audits, support staff readiness, and help establish a structured path toward accreditation.
Does Qlaxy provide scientific and experimental consulting?
Yes. Qlaxy provides clause-by-clause compliance mapping, mock audits, staff training, documentation restructuring, and final accreditation-readiness support.
What does the Qlaxy consulting process look like?
Qlaxy follows a structured four-phase approach: Gap Assessment → QMS & Documentation → Mock Audits & Training → Accreditation & Beyond. This takes the laboratory from identifying compliance gaps through audit readiness and ongoing quality improvement.
How can I get started with Qlaxy?
You can start with a free gap assessment/consultation. Qlaxy will evaluate your laboratory’s requirements and help define a structured path toward quality-system improvement and accreditation readiness.
ACCREDICHECK BY QLAXY
Don't guess your lab's readiness —
score it in under 10 minutes.
Before your consultation, get a clear, objective picture of exactly where your laboratory stands today. AccrediCheck is Qlaxy’s intelligent scoring calculator — it maps your lab across 8 NABL & ISO 15189 quality domains, pinpoints compliance gaps, and delivers a personalised readiness score and priority action report straight to you.
- Covers all 8 NABL & ISO 15189 quality domains
- Personalised score + prioritised gap report delivered to your inbox
- Takes under 10 minutes — know your status today
- Built specifically for molecular clinical labs
YOUR READINESS SCORE
Illustrative — complete the assessment to get your lab’s actual score
Ready to build your audit-ready lab?
Start with a free gap assessment. We’ll define your clear, structured path to accreditation — from day one.