IJCA - Volume 2 - Flipbook - Page 52
52 The International Journal of Conformity Assessment
DOI: doi.org/10.55459/IJCA/v2i1/VM
Experience in Implementing ISO 15189:2012
Accreditation at Chimera Transplant Research Foundation:
A Molecular Testing Laboratory
By Dr. Vikash C Mishra, Dinesh Chandra, and Dr. Vimarsh Raina
-ABSTRACTISO15189:2012 is a formal recognition by an
authorized national accreditation body that a testing
laboratory is competent to carry out specific tasks
according to the standard. This article aims to
share the experience of reaching ISO 15189:2012
accreditation at Chimera labs. A gap analysis
was performed, followed by the preparation and
implementation of policies and procedures for the
effective implementation of QMS. After six months
of intensive work, including mentoring activities,
the laboratory was ISO 15189 accredited in the
field of medical genetics and related HLA and
immunogenetics by the National Accreditation
Board for Testing and Calibration Laboratories, India.
Our experience suggests that the implementation
of a quality management system is possible even
in small-sized laboratories with the help of skilled
manpower and supportive management.
Keywords: ISO15189, ISO15189:2012, accreditation, NABL
Introduction
Chimera Transplant Research Foundation (CTRF)
was established in December 2012 and serves to
provide cost-effective and quality diagnostic and
consulting aid for successful transplant operations
to tertiary care hospitals. Since its foundation, CTRF
has seen steady growth, serving more than 28,000
patients all over the country. Expertise in transplant
immunology and DNA analysis makes CTRF the
leader in the niche segment and helps hospitals fulfill
the legal formalities of a transplant while complying
with all legalities.
The current globally accepted standard for
medical laboratory practice is ISO 15189 (medical
laboratories), which was developed by the
International Organization for Standardization
[1]. ISO 15189 accreditation enables the medical
testing laboratory to demonstrate to its clients the
effectiveness and reliability of the services [2]. The
content of ISO 15189 is broadly categorized into two
sections: management requirements and technical
requirements. The accreditation will help any testing
laboratory in its international recognition, continual
improvement, and enhanced customer confidence
and satisfaction. Hence, being in the arena of
medical testing laboratories, we had planned for the
accreditation of ISO 15189:2012 in mid-2013. The
following will attempt to summarize the author’s
experience with ISO 15189 accreditation at Chimera
labs and the implementation of an effective quality
management system (QMS).
Material and Methods
Gap Analysis
The gap analysis of the available resources of the
laboratory was done to get the baseline information
for the effective implementation of the quality
management system. This was done by comparing
the existing resources from the ISO 15189:2012
standard. This gap analysis resulted in several
nonconformities and broadly included the absence
of established policies and standard operating
procedures, due to a lack of knowledge about the ISO
15189 standard. All this information was recorded
and presented to management for making an action
plan to overcome these issues.
Implementation of an Effective Quality Management
System per ISO 15189
Management appointed a trained and experienced
laboratory director and quality manager for the
preparation and implementation of the quality
management system. All the policies, procedures,
and records were prepared and maintained as
per the standard in coordination with the quality
manager and laboratory director at Chimera labs.
Internal Audit
An internal audit was done once all the preparation
had been completed by a trained ISO 15189:2012
external auditor. Despite intensive preparations, six
non-conformities were observed. After the closure
of these non-conformities, management decided to
apply four tests under the scope of accreditation for
ISO 15189.
