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In 2021, the International Organization for Standardization published part three of the ISO 16140 series, ISO 16140-3:2021, which provides the protocols for verification of reference and validated alternative methods in a single laboratory. This standard can assist food laboratories in conducting verification of validated microbiology methods in their laboratories, demonstrating their ability to use these methods for testing samples (food, feed, environmental and primary production) within the laboratory’s scope to meet accreditation to ISO 17025:2017.

As part of Neogen Food Safety’s educational webinar series, Neogen’s Lead Regulatory Specialist, DeAnn Benesh, sat down with three panelists from Nestlé Research, Q Laboratories, and Campden BRI to discuss their experience in the use and implementation of the ISO 16140-3:2021 standard. Watch the webinar.

Attendees were reminded of two key points before the roundtable discussion began:

1. Verification vs. validation
   These two terms are often incorrectly used interchangeably:
   1. Validation: Is about the METHOD
      The process of proving whether the performance characteristics of a particular testing method is suitable for its intended use or, more specifically, whether the testing process can accurately detect specified microorganisms. Typically, this process is done when a new test method is introduced or when there is a change in the testing method.
   2. Verification: Is about the USER of the validated method
      Confirmation that an individual lab or individual user can use the validated method and that the method performs as specified in the validation study. This process is usually conducted on an ongoing basis within a lab to ensure the validated method is still performing as indicated.
      
      
2. Does publication of the standard mean I need to re-verify my methods?
   With the publication of the ISO 16140-3:2021, methods do not lose their verification status unless changes or additions are made to the method. Below are three common situations laboratories might encounter regarding the possible need to re-conduct method verification:
   1. Methods already accredited under the scope of laboratory application:
      Re-verification should not be required if no changes have been made to the method.
   2. Methods or food categories new to the scope of laboratory application:
      New methods added to the laboratory or additional food categories added to current methods that the laboratory would like to include in their scope of accreditation would need verification before implementation.
   3. Methods revised after they have been accredited under the scope of laboratory application:
      Re-verification of the method will depend on whether these changes are deemed (by the certification organization) to be major or minor changes to the method. If the certification organization requires additional validation study for the method to support the method change, then the laboratory using the method would need to reverify the method before re-implementation in their laboratory.
      
      

Refer to the ISO TC34/SC9 website for more information regarding method validation and verification.

To learn more about the implementation of the standard in the industry as well as the verification of methods for food safety testing, watch Neogen Food Safety’s webinar “ISO 16140-3:2021 Method Verification Roundtable: Perspectives From the Industry” here.

For help applying the ISO 16140 series to your lab’s food safety testing methods, contact your Neogen Food Safety representative.

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