A Guide to Total Quality Management System (TQMS) in Molecular Diagnostics from Experiences in Seeking Accreditation and Implementation-Reference-Cited by-同舟云学术

A Guide to Total Quality Management System (TQMS) in Molecular Diagnostics from Experiences in Seeking Accreditation and Implementation

Published:2018-11-23 Issue:2 Volume:1 Page:123-133
ISSN:2523-8973
Container-title:SN Comprehensive Clinical Medicine
language:en
Short-container-title:SN Compr. Clin. Med.

Author:

Dayakar Seetha,Pillai Heera R.,Kalpathodi Sanughosh,Jeya Chandran Ganesan,Nair Radhakrishnan R.

Publisher

Springer Science and Business Media LLC

Link

http://link.springer.com/article/10.1007/s42399-018-0018-3/fulltext.html

Reference48 articles.

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2. • Berwouts S, Morris MA, Dequeker E. Approaches to quality management and accreditation in a genetic testing laboratory. Eur J Hum Genet. 2010;18(l1):S1–19. https://doi.org/10.1038/ejhg.2010.104 This study focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement.

3. Guzel O, Guner EI. ISO 15189 accreditation: requirements for quality and competence of medical laboratories, experience of a laboratory I. Clin Biochem. 2009;42(4–5):274–8. https://doi.org/10.1016/j.clinbiochem.2008.09.011 .

4. •• Newman H, Maritz J. Basic overview of method validation in the clinical virology laboratory. Rev Med Virol. 2017:e1940.1–7. https://doi.org/10.1002/rmv.1940 This review will provide a basic overview of method validation/verification, specific for clinical virology laboratories, and includes explanation of statistical analysis and acceptance/rejection criteria.

5. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Off J Eur Communities 1998 (Dec 7); L331:1–37. Available at http://www.gmp-compliance.org/guidemgr/files/IVD_DIRECTIVE.PDF. Accessed 20 July 201 8.

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