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ISO 15189 Medical laboratories - Particular requirements for quality and competence

This standard is basically the application of the ISO/IEC 17025 and ISO 9001 standards to a Medical Laboratory.

Accreditation to ISO 15189 requires that:

The laboratory has a quality system meeting requirements of ISO 15189.

The lab facility has adequate equipment to perform its testing tasks.

The lab facility has adequate laboratory personnel with the competence to perform the testing.

In addition most accreditation schemes in the United States require proficiency testing amongst the laboratories.

Therefore, ISO 15189 is recognition of medical laboratory competence, while ISO/IEC 17025 and ISO 9000 are simply recognition of competency of a laboratory management system.


The intent of ISO 15189 is to provide confidence in medical laboratories because medical services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients.

Training Offered

ISO 15189 Awareness/Overview

ISO 15189 Auditor/Assessor Training

ISO 15189 Implementation Workshop

Measurement Uncertainty

Internal Auditor Training 

Advanced Internal Quality Auditor Training

Advanced Product Quality Planning (APQP)

Failure Mode Effects Analysis (FMEA)

Control Plan Methodology (CP)

Statistical Process Control (SPC)

Measurement Systems Analysis/Gage R & R (MSA)

Business Operating System (BOS)

Customer Satisfaction

Process Flowcharting Workshop

Team Oriented Problem Solving (8D)

Document Writing


Services Offered

Initial System Evaluation (Gap Analysis)

Documentation Development

Implementation Assistance and Guidance

Final System Evaluation (Dress Rehearsal)

Hands-on Auditing

Contract Internal Auditing Program

Compliance Auditing