ISO 15189 Accreditation Software

ISO 15189 Compliance
For Labs Worldwide

LabComply is the international laboratory management system built for ISO 15189 accreditation. QMS documentation, risk management, competency tracking, and audit management — all in one platform.

United StatesUnited KingdomCanadaAustraliaUAESaudi ArabiaIndiaNigeriaSouth AfricaSingapore

No credit card required · Available worldwide · ISO 15189:2022 aligned

ISO 15189:2022UKAS (UK)NATA (Australia)CALA (Canada)NABL (India)ILAC RecognizedCAP AccreditationHIPAA Compliant

Complete ISO 15189 Management System

Every ISO 15189 clause covered in one integrated platform designed for international medical laboratories.

Quality Management System

Complete QMS documentation aligned with ISO 15189 clause requirements.

Risk Management

Risk identification, assessment, and mitigation tracking per ISO 15189:2022.

Personnel Competency

Competency assessments, training records, and qualification documentation.

Measurement Uncertainty

MU calculation templates and documentation for all test methods.

Equipment Management

Calibration schedules, maintenance logs, and equipment qualification records.

Internal Audit Module

Audit planning, finding tracking, and corrective action management.

ISO 15189 FAQs

What is ISO 15189?

ISO 15189 is the international standard for medical laboratory quality and competence. It specifies requirements for quality management systems and technical competence in medical laboratories worldwide.

Which countries require ISO 15189?

ISO 15189 is recognized globally and is required or strongly recommended in the UK (UKAS), Australia (NATA), Canada (CALA), UAE, Saudi Arabia, India (NABL), and many other countries as the primary laboratory accreditation standard.

How does LabComply support ISO 15189 compliance?

LabComply covers all ISO 15189 requirements including quality management system documentation, risk management, personnel competency, equipment management, measurement uncertainty, internal audits, and management review.

Is LabComply available outside the United States?

Yes. LabComply is available worldwide and supports ISO 15189 accreditation requirements for labs in the UK, Canada, Australia, UAE, Saudi Arabia, India, and all other countries.

Ready for ISO 15189 Accreditation?

Join medical laboratories worldwide using LabComply to achieve and maintain ISO 15189 accreditation.