IJCA - Volume 3 - Flipbook - Page 65
2024 | Volume 3, Issue 1
Conclusion
Laboratories must demonstrate (verify) they can
properly use methods before implementing in their
facility. The publication of ISO 16140-3:2021 now
provides an internationally recognized standard
for method veri昀椀cation that can be used to meet
the methods veri昀椀cation requirement of the ISO
17025:2017 standard. In this article, examples of
qualitative and quantitative methods were provided
using both AOAC and ISO validated methods to
get you started, and it is highly recommended that
you also check out additional sources of training
to deepen your understanding and application of
the ISO 16140-3:2017 standard. On the ISO TC34/
SC9 website,10 you can 昀椀nd a number of materials
available to help you with the use and application
of this standard, including a recording of a webinar
delivered on 2 March 2020 by ISO members shortly
after the publication of the standard, and several
PowerPoint® training presentations that were
developed for your use. The slide presentations
have the script for each slide written in the slide
notes to help you properly deliver their content.
The presentations are available in both PDF and in
PowerPoint format so that you have the ability to
translate the content into your local language to help
with presentation and understanding.
Presentation: Overview of the ISO 16140 series
– standards for validation and veri昀椀cation of
microbiology methods (PDF or PowerPoint)
Presentation: Overview of ISO 16140-3 ‘Method
veri昀椀cation’ – improving con昀椀dence in laboratory
results (PDF or PowerPoint)
Presentation: “Deep dive” into ISO 16140-3
‘Method veri昀椀cation’ – an extended training for
improving con昀椀dence in laboratory results (PDF or
PowerPoint)
Excel-calculation tool ISO 16140-3:2021 for
assistance on statistics (link)
Recording of the Webinar on 2 March 2021:
Publication ISO 16140-3 ‘Method veri昀椀cation’ in
English (link)
Webinar in French on 1 April 2022: Publication ISO
16140-3 ‘Method veri昀椀cation’ (Presentation mainly
in English and Recording)
Frequently Asked Questions for ISO 16140-3:2021
‘Method veri昀椀cation’ (link)
63
NOTE
3M’s former Food Safety business and product
portfolio, including Petri昀椀lm Plates and Molecular
Detection Assays, are now part of Neogen.
For additional questions and support regarding the
application of ISO 16140-3 in your laboratory, please
contact Neogen at www.neogen.com
Acknowledgements
I would like to thank my Neogen colleagues Cari Lingle
and Gabriela Lopez. The three of us created and
presented this information in a webinar held in April of
2021, just after the publication of the ISO 16140-3:2021
standard. Following the webinar, I transformed our
presentation materials into this article.
Author Biography
DeAnn Benesh recently retired from
Neogen where she was a Global
Regulatory Manager providing
leadership to global teams to
engage in strategic local regulatory
activities to drive recognition
and acceptance of methods, and
partner with government and nongovernment organizations in the
development of standards and methods. She was a
Past President and Fellow of AOAC, active in ISO IC34/
SC9 as an expert participating in several ISO 34/SC9
Working Groups, Co-leader of the ISO 16140-3 (Method
Veri昀椀cation) drafting committing, a member of the
Microval General Council, past Chair of the IAFP Food
Law and of the IAFP International Food Protection
Issues Professional Development Groups, and
recipient of the IAFP President’s Recognition Award.
DeAnn holds a Bachelor of Science degree in Medical
Technology from the College of Pathology, University
of Minnesota, Minneapolis, MN; a Mini master’s in
international business from the University of St.
Thomas, St. Paul, MN; and a Certi昀椀cate in International
Food Law through Michigan State University, East
Lansing, MI.
References
1.
ISO/IEC 17025:2017 General requirements
for the competence of testing and calibration
laboratories.
2. NATA Technical Note 17- October 2013: Guidelines
for validation and veri昀椀cation of quantitative and
qualitative test methods.
