IJCA - Volume 2 - Flipbook - Page 54
54 The International Journal of Conformity Assessment
which has revealed that clinicians at the hospital
were able to trust and make clinical decisions
supported by laboratory results.
Formal recognition of the competence of a
conformity assessment body for ISO 15189:2012 has
many advantages including robust QMS, assurance
of accurate and reliable results, and enhanced
customer confidence and satisfaction, which
ultimately results in a potential increase in business
for the laboratory.
Conclusion
Our experience suggests that implementation of a
QMS is possible – even in resource-limited small
size laboratories such as ours – when adequately
supported by management. Achieving effective
implementation of the ISO 15189 standard requires
trained and well-motivated laboratory associates.
Regular trend analysis of all objectives and quality
indicators is necessary and should be done by
laboratory professionals trained in QMS who have
implemented the system. Additionally, skilled,
motivated associates and supportive management
are keys to achieving and implementing an ISO15189
accreditation. Each medical testing laboratory
should go for ISO 1589:2012 accreditation as it
offers international recognition resulting in access
to the global market and, finally, improved customer
acquisition and satisfaction.
Source of funding: None
Conflicts of interest: There is no conflict of interest.
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References
[1]. Zeh, Clement E., Seth C. Inzaule, Valentine O. Magero, Timothy
K. Thomas, Kayla F. Laserson, Clyde E. Hart, and John N.
Nkengasong. “Field experience in implementing ISO 15189 in
Kisumu, Kenya.” American Journal of Clinical Pathology 134,
no. 3 (2010): 410-418.
[2]. Fedele, A., G. Avruscio, L. Barison, and A. Scipioni. “Standards
to support ISO 15189 implementation for medical laboratories
accreditation.” Clin Case Rep Int. 2022; 6 1310.
[3]. https://nabl-india.org/ (Accessed 26 September 2022)
Author Biographies
Dr. Vikash C Mishra (Ph.D. Biotechnology) is
working as a quality Manager at Chimera Transplant
Research Foundation (www.chimeralabs.org) , New
Delhi, India. He has more than 12 years of working
experience in the area of transplant immunology and
immunogenetics. He has a keen interest in translating
healthcare research for the benefit of the masses.
He has in-depth knowledge of ISO 15189:2012
guidelines He has more than 30 research articles
in peer-reviewed international journals with a high
impact factor. He is an advisory member of Chimera
EQAS (https://eqas.in/) and also a member of the
Genebandhu ethics committee (http://ethicsindia.org.
in/).”
©Freepik
