Every Standard.
Every Sector.
One Partner.
From a single-room diagnostic centre to a 500-bed hospital — we deliver end-to-end accreditation and certification consultancy across all major Indian and international quality standards.
Medical Laboratory
Accreditation
Expert consultancy for ISO 15189:2022 accreditation covering medical laboratories and medical imaging — across all recognized disciplines, through every accreditation body in India.
All Pathology &
Medical Imaging Disciplines
From Gap Analysis
to Certificate in Hand.
Initial Gap Analysis
Onsite system study to understand your laboratory’s existing setup and compliance level. Delivers a customised action plan and final quotation. Fee: ₹2,500
Documentation & QMS
Complete quality manual, SOPs, policies, and records — written and customised to your scope, disciplines, and accreditation body requirements.
Training & Implementation
Staff training across all phases — pre-examination, examination, and post-examination. Quality indicators setup, risk assessment, and system embedding.
Internal Audit & Mock Assessment
Rigorous mock assessment by our experts. Every non-conformity identified and closed before it counts. More thorough than the official visit.
Assessment & Award
On-site support during official assessment. Immediate CAPA management. We do not leave until your certificate is awarded.
Annual Maintenance
Ongoing internal audit support, document review, and compliance assistance for periodic NABL surveillance or renewal. From ₹12,500/year
Transparent Pricing.
No Surprises.
The first step. Understand your current compliance level before committing to full consultancy.
End-to-end support from documentation to certificate. Final cost based on lab size, scope, and setup.
NABL Medical Entry Level Testing program for labs performing basic testing — ideal first step toward full accreditation.
We Work With Every
Recognised Body in India.
Testing & Calibration
Laboratory Accreditation
Comprehensive consultancy for ISO/IEC 17025:2017 accreditation across all major testing and calibration disciplines — covering NABL, QAI, FDAS, and IQAS accreditation bodies.
Our expertise also extends to Proficiency Testing Providers (PTP) under ISO/IEC 17043 and Reference Material Producers (RMP) under ISO 17034 — making us a single partner for the entire testing ecosystem.
Structured Guidance.
Proven Results.
Gap Analysis Visit
Onsite laboratory visit to assess existing setup against ISO/IEC 17025 requirements. Delivers gap report and customised quotation. Fee: ₹2,500
QMS Documentation
Quality manual, SOPs, method validation documents, uncertainty budgets, and all records required by the standard and accreditation body.
Implementation & Training
Hands-on implementation support across all laboratory departments. Technical staff training on method validation, uncertainty, and QMS requirements.
Pre-Assessment & Mock Audit
Full audit simulation, NCs identification, and CAPA planning. Leaves your lab fully prepared for the official assessment. From ₹10,000
Official Assessment Support
On-site presence during the NABL / QAI / FDAS / IQAS assessment. Immediate corrective action handling for any observations raised.
Annual Maintenance
Internal audits, document reviews, and ongoing support for NABL surveillance or renewal cycles. From ₹15,000/year
Affordable. Transparent.
Results-Driven.
First step before full engagement. Understand your compliance baseline.
Standalone lab or corporate/institutional setup. Final price based on scope and lab size.
Targeted mock audit and CAPA planning for labs that have done some preparation and need final readiness assessment.
Beyond Testing Labs — The Full Ecosystem.
17043
17034
20387
Hospital & Healthcare
Accreditation
End-to-end consultancy for NABH accreditation — for hospitals, nursing homes, clinics, diagnostic centres, and all healthcare facilities. From Entry Level to Full Accreditation.
We have successfully assisted 17+ hospitals (including Entry Level certifications) in meeting accreditation requirements, improving healthcare standards, and ensuring excellence in patient care.
Gap Analysis
Onsite/remote evaluation against NABH standards. Customised action plan with department-wise compliance map.
Documentation Support
SOPs, policies, manuals, and checklists — all templates prepared as per NABH standards for every chapter.
Training & Capacity Building
Clinical and non-clinical training. Fire safety, infection control, quality management, mock audits and drills.
Implementation Guidance
Department-wise support, quality indicator setup, risk assessment and mitigation strategies.
Internal Audits & Pre-Assessment
Mock audits to identify weak spots, on-the-spot corrections, and assessor-level feedback and coaching.
Post-Accreditation Support
Annual updates, ongoing audit support, and complete reaccreditation guidance for sustained compliance.
Flexible Pricing for
Every Facility Size.
Pricing is based on the size and scope of your healthcare facility. All packages include end-to-end support through assessment day.
Medical Devices
Certification
Expert consultancy for medical device manufacturers seeking ISO 13485 certification and the Indian Certification of Medical Devices (ICMED) — ensuring product quality, regulatory compliance, and market access.
ISO 13485 certification facilitates access to global markets including Europe (CE marking), Canada, and other regulated regions. ICMED — an initiative by QCI and AiMeD — supports Make in India and simplifies CDSCO regulatory clearances.
We Cover All Four
Medical Device Classes.
Pricing for consultancy services depends on the risk class of your medical device as per CDSCO guidelines.
e.g. Thermometers, surgical gloves, hospital furniture, tongue depressors
e.g. Hypodermic needles, suction equipment, simple breathing masks
e.g. Infusion pumps, bone fixation plates, dialysis machines
e.g. Heart valves, implantable defibrillators, CNS electrodes
Indian Certification of
Medical Devices.
An initiative by QCI and AiMeD to standardise and improve the quality of medical devices manufactured in India — supporting Make in India and global export readiness.
Based on ISO 9001 — general quality management system. Entry-level Indian device certification for establishing foundational quality processes.
Based on ISO 13485 — device-specific quality management system. Demonstrates compliance with India’s device-quality framework and international standards alignment.
Includes product testing and certification for performance and safety. The highest level of ICMED — signals comprehensive quality and safety assurance to buyers and regulators.
Gap Analysis & Documentation
Complete QMS documentation as per ISO 13485:2016 — customised to your device class and certification body.
QMS Implementation & Internal Audits
Hands-on implementation, management reviews, and internal audit program design and execution.
Certification Body Coordination
Coordination with TÜV SÜD, BSI, Intertek, UL, DNV GL, SGS, IRCLASS, and other accredited bodies — based on your market access goals.
Certifications That Build
Real Business Value.
For organisations seeking ISO management system certifications — we implement systems that become genuine business advantages, not certificates that gather dust in a frame.
The world’s most recognised quality management standard. ISO 9001:2015 demonstrates your organisation’s ability to consistently provide products and services that meet customer and regulatory requirements. Applicable to any organisation, any size, any sector.
ISO 14001:2015 helps organisations identify, manage, monitor, and control their environmental impact systematically. Demonstrates environmental responsibility to clients, regulators, and investors — and often required for government tenders and export markets.
ISO 45001:2018 provides a framework to improve employee safety, reduce workplace risks, and create better, safer working conditions. Builds on OHSAS 18001, with stronger emphasis on leadership, worker participation, and organisational context.
From Implementation
to Certification.
Gap Analysis
Assessment of your current operations against the chosen standard’s requirements. Clear, prioritised gap report delivered within 7 working days.
QMS Documentation
Quality manual, procedures, work instructions, and records — fully customised to your organisation’s context, size, and sector.
Training & Implementation
Staff awareness training, process owner training, and hands-on implementation support across all departments.
Internal Audit
Full-scope internal audit, management review facilitation, and CAPA closure — leaving no non-conformity open before the certification audit.
Certification Audit Support
On-site support during Stage 1 and Stage 2 certification audits. Coordination with the certification body and immediate CAPA handling.
Surveillance & Renewal
Ongoing support for annual surveillance audits and 3-year recertification cycles — ensuring your certificate remains valid and your system evolves.
Your Accreditation Begins
with a Single Conversation.
Free 60-minute strategy session for every prospective client. No obligations — just an honest assessment of where you stand and exactly how we will get you to your certificate.