GUIDE TO TESTING | BIO-RAD

New Food Guide to Testing Supplement | Volume 23, Issue 04

the controls carried out for batch release. It
is a guarantee of seriousness and competence
which is validated by independent experts.

Increaseconfidence withmethod validationand supplieraccreditation

Q: Do you consider ISO 17025
as a key accreditation for amanufacturer and do you think
this standard is a ‘must have’ for
now and the coming years?
LMR: Quality control certificates issued

After obtaining ISO 17025 accreditation of its quality control laboratory, Yannick Bichot of Bio-Rad outlinesthe process, the challenges and the benefits – including an interview with two key participants.
CONSUMER DEMAND for food quality
and safety take a prominent place in oursociety. For all players in the food chain, thistranslates into the implementation of systems
and processes aimed at controlling risks andstriving for very high quality products placedon the market.
From a microbiological point of view, thecontrol of risk requires the establishment ofacceptance or rejection criteria, involving
controls using analytical methods ofdetection or enumeration of microorganisms.
These methods, made compulsory most of
the time by local or international legislation,
can be described in international standards
or alternative methods. The developmentof these alternative methods meets boththe specific needs of certain sectors, such as
reducing the time required to deliver results,
and more general needs such as optimising
analysis flows or automating laboratories.
In order to ensure that these alternativemethods have equivalent performance to thereference methods, different benchmarks formethod comparison have been developed, suchas ISO 16140-2:2016 or AOAC validations.
As part of these validations, comparison studies
are conducted by independent expert laboratories
within evaluation structures composed ofindependent technical experts. Concretely,
alternative methods that are candidates forvalidation are characterised on the basis ofa set of exhaustive technical criteria in order todemonstrate their equivalence with the reference
method. The main criteria evaluated include:

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Sensitivity/specificity
Relative limit of detection
Inclusivity/exclusivity
Relative trueness (for quantitative methods)
Accuracy profile (for quantitative methods).

approach is demanding and complementary
to other supplier certification systems such asISO 13485 or ISO 9001.
In June 2020, Bio-Rad obtained ISO 17025
accreditation of its quality control laboratoryfrom Cofrac. Louis-Marie Roque, Cofracauditor and independent consultant, andJean-Michel Plancq, Bio-Rad Quality Manager,
explain how this approach was implemented,
the challenges encountered and the benefits
for customers using Bio-Rad methods in
an interview (below) with Yannick Bichot,
Business Unit Marketing Manager, Food
Science Division, Bio-Rad Laboratories.

Q: You recently accompanied Bio‑Rad
in its ISO 17025 accreditation
process. What was your role?

The reproducibility of the alternative method isalso evaluated through an interlaboratory study
involving several evaluation laboratories.
In addition to method validation,accreditation allows user laboratories to choose
a supplier adapted to their needs. ISO 17025
accreditation is now widely adopted by food andwater microbiology laboratories. More recently,
the application of this standard by the quality
control laboratories of culture media suppliers
has become a strong recommendation of somenational accreditation bodies. This ISO 17025

LMR: My role was to help Bio-Rad in its
accreditation process according to theISO 17 025 standard, more specificallyfor the technical part. The culture media
preparation unit was already operating withrigor; the work consisted of resuming theprocesses to comply with those of ISO 17025.

Q: Can you describe how ISO 17025
applies to a method provider inwater and food microbiology?

LMR: Accreditation is recognition of thecompetence of a body to perform the services
specified in its scope (of accreditation).
For a manufacturer of a method in waterand food microbiology testing, it allows its
customers to guarantee the conformity ofnewfoodmagazine.com

by a manufacturer under ISO 17025
accreditation provide irrefutable proof thatthese controls are in conformity. In a world
where customer requirements are becoming
more important, being able to deliver productswith quality control under accreditation isa guarantee of seriousness and confidence.
Accreditation is recognised worldwide thanks
to multilateral recognition agreements and will
become an essential element in the future.

Q: What are the benefits fora laboratory to use an ISO 17025
accredited supplier?

LMR: Accreditation is a sign of trust.
It allows a laboratory to trust its accredited
subcontractor and to lighten its own internal
laboratory controls. The ISO 17025 standard inits chapter 6.6 states that: ‘The laboratory shallensure that it only uses suitable products andservices, when they are provided by external
providers and have an influence on laboratory
activities’. If the provider is not accredited, thelaboratory must monitor the products andservices to ensure their performance. In thecase of an accredited provider, these controls
can be greatly reduced. The accreditation of
the service provider will allow the laboratory
to take this competence into account and toconsider it in its risk analysis.

Q: What was your perceptionof Bio-Rad as a company andmore specifically the global
quality management system?

LMR: The audit of Bio-Rad made it possible torealise that the level of quality requirements wasalready included in the structure. Admittedly,
certain subtleties of the ISO 17025 standard
were not considered, particularly with regard
to the formalisation of the acceptance criteria
for staff training, but on the whole, the rigor,traceability and a concern for continuousimprovement were already present. Bio-Rad
obtained its accreditation (from its first initialaudit, with little deviation) for the control ofculture media according to the ISO 11133
standard, which requires a very large
number of skills.
@NewFoodMag

Q: Why is quality soimportant to Bio-Rad?

JMP: Bio-Rad is a company which
promotes strong customer relationships
based on understanding and meeting theirrequirements, responding to their feedback
and providing support.

Q: How is the activity ofthe quality control
laboratory organised?

JMP: The laboratory has built itsown quality system which evolves
within the existing system using a largepart of the existing documentation.
This integrates the new requirements ofthe standard and the documents issued
by the French Accreditation Committee.
In concrete terms, the laboratory has
its own management review and internal
non-conformity declaration process.
The metrology, sampling and results
reporting procedures have been adaptedand strengthened and operating procedures(or methods) have been developed.

Q: Can you explain how this newaccreditation is complementary
to the other ones?

JMP: As previously mentioned, theaccreditation of the laboratory is fully integrated
into the existing quality system and thespecificities implemented are considered asstrengths and not constraints. It allows us to be
more efficient as well as ISO 13485 certificationand compliance with GMP.

Q: You are used toaccreditations for clinicaldiagnostics products, the ISO 17025
was the first for food and water
testing products - what werethe most challenging points
for this implementation?

JMP: Standard 17025 has similarities withquality management standards such as 13485
and with GMP, however, some aspects werecompletely unknown to us. For example, theapproach on the selection of methods andtheir validation, the rendering of results or
test reports. The use of the Cofrac logo makes
us proud and also responsible because ourapproach is part of the continuity.

a suppliers' quality control laboratories
increases confidence and facilitates theimplementation of methods in user
laboratories. These two approaches, which
complement each other, are a solidificationof competitiveness for food and water
microbiology labs.

Yannick Bichot
Yannick Bichot is theBusiness Unit Marketing
Manager, Food Science
Division at Bio-RadLaboratories in France.
He spent five years ina French veterinary
laboratory during the BSEcrisis. Since 2005, he has
been working at Bio-Rad in Food Microbiology
and Veterinary Testing in different technicaland marketing positions. He is a member of theAFNOR Agri-food Validation Commission andtechnical reviewer for NF Validation TechnicalBoard. He is also a member of the AFNOR/
V08B French standardisation commission
for food microbiology test methods.

Louis-MarieRocque
With an engineering degree
in molecular biology,
Louis‑Marie Rocque
founded an agri-foodanalysis laboratory
specialising in research intoGMOs. He has been a Cofracassessor since 2009
within the field of water and food microbiology,molecular microbiology in GMOs, and animal health.
He is also an active member of the AFNOR T90D
commission (water microbiology), convenor of
the ISO WG17 commission (PCR in water), and anexpert within Afnor Validation. Louis-Marie has
been a quality consultant for four years and is now
the manager of a start-up in molecular biology.

Jean-Michel Plancq
Jean-Michel Plancq trained
as a biochemist and has
spent most of his career at
Bio-Rad. He successively
held the positions ofQuality Control Manager
then Production Manager
before joining the Quality
Assurance department
in 2000. He participated in the launch of the first
AIDS screening tests in 1985 and the BSE test in
2001. Jean-Michel also developed the Site System
Quality System for the Steenvoorde manufacturing
plant in accordance with the Medical Device
Single Audit Program (MDSAP) and US GMP. He is
now Quality Assurance Manager of the plant.

Conclusion

Certification processes allow the selectionof methods where performance has beencharacterised and which meet the international
regulations in force. Accreditation of

For further information, visit:www.bio-rad.com/foodscience2