IJCA - Volume 2 - Flipbook - Page 53
2023 | Volume 2, Issue 1
53
Discussion
Implementation of ISO 15189:2012 in the laboratory
was a wonderful experience and produced a need
to maintain quality for the tests under the scope
of accreditation, which ultimately benefits the end
user (e.g., patient, clinician). Continuous monitoring
of all the policies, procedures, quality objectives
and quality indicators is done at regular intervals to
maintain the QMS as per ISO 15189:2012.
Management Review Meeting (MRM)
MRM is conducted every year in the CTRF lab and
output from the management review is incorporated
into a record. MRM is one of the key factors for
improving the system.
Internal Audit
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The laboratory has derived a procedure for
conducting internal audits. The audits are conducted
on an annual basis. During the internal audits, all
the quality activities of the laboratory functions are
assessed.
Results
Interlaboratory Comparison or EQAS Participation
Quality Management System
The CTRF has a protocol to assure the quality of
all examination procedures being performed in
the laboratory. To achieve this, the lab participates
preferably in an External Quality Assessment
(EQA) proficiency testing program. In the case that
EQAS is not available nationally or suitable for the
particular testing, the laboratory sends the sample
for a proficiency check to the other NABL accredited
(ISO15189) laboratories.
The preparation of the accreditation resulted in an
effective Quality Management System supported
by the policies, procedures and records as per the
standard ISO 15189:2012.
ISO 15189:2012 Accreditation
After intensive preparation and management
approval, the procedure of accreditation was
started by submitting of application form in the
field of medical genetics and related HLA and
immunogenetics in September 2014. The onsite
pre-assessment was done in January 2015. A total
of six nonconformities were identified after the
inspection. All the nonconformities were closed
satisfactorily within the provided time frame and the
laboratory was recommended for final assessment.
The first assessment was done in April 2015 and
four tests were recommended for the scope of
accreditation in the field of medical genetics and
related HLA and immunogenetics by the National
Accreditation Board for Testing and Calibration
Laboratories(NABL), India [3]. The total numbers of
nonconformities observed were nine. At present, 25
tests are under the scope of accreditation for ISO
15189:2012. A total of four onsite and three desktop
assessments were done for the continuation of
accreditation.
As per the policy, the lab regularly accomplishes
trend analysis of quality objectives and quality or
key performance indicators, vendor evaluation,
document review, and internal audit. The laboratory
director and quality manager of the laboratory play
a pivotal role in the effective implementation of the
QMS. Regular mentorship by the laboratory director
and quality manager with strong leadership skills
transformed the laboratory into a quality-driven
organization. CTRF conducts weekly seminars
for regular updates on its associates on recent
advances in the field of transplant immunology.
The weekly seminar is conducted by each of the
associates on a rotating basis. These weekly
sessions contribute to over-development of each
associate by updating their scientific knowledge and
enhancing their skill sets.
Regular customer feedback is taken to measure
what clinicians think about the laboratory services,
