Steps towards ISO15189:2012 and ISO15190:2003 accreditation

June 26, 2019

Steps towards ISO15189:2012 and ISO15190:2003 accreditation

Laboratory services are a key component of quality healthcare. Laboratories are nowadays providing not only highly reliable results but also quality patient-focused services. To maintain quality, competence and safety in medical laboratories, Quality Management Systems (QMS) are essential.

CILM has implemented QMS since May 2014 by using the WHO Laboratory Quality Stepwise Implementing (LQSI) tools as a guide to implementing a QMS in accordance with the requirements of ISO15189:2012 and ISO15190:2003.
CILM has had three assessments for LQSI tools and four assessments for ISO15189:2012 and ISO15190:2003 requirements.

Assessments based on LQSI tools LQSI tools include 12 elements in 4 phases such as:

  • Facilities and safety
  • Organization
  • Personnel
  • Equipment
  • Purchase and inventory
  • Process management
  • Information management
  • Documents and records
  • Customer focus
  • Assessment
  • Nonconformity management
  • Continual improvement

LQSI tools

Since 2015, CILM had has five external and several internal assessments.
The graph below shows the assessments of external organizations (Integrated Quality Laboratories Services (IQLS), DATOS, National Center for Laboratory and Epidemiology (NCLE) and WHO.

  • Assessments based on ISO15189:2012 and ISO15190:2003 requirements
  • ISO15189:2012: Medical Laboratories – Requirements for quality and competence
  • ISO15190:2003: Medical Laboratories – Requirements for safety

In December 2017 and November 2018, CILM was assessed by Program for HIV Prevention and Treatment (PHPT) Research Unit, Thailand.
In January 2019, CILM requested pre-assessment from the Bureau of Laboratory Quality Standards (BLQS), Thailand. In March 2019, CILM requested accreditation assessment from BLQS, Thailand.

The application has been submitted and is being considered by the BLQS committee in Thailand.