Due to the growing need for quick, convenient and reliable analyses, a large number of commercial kits are used on the microbiological analysis market (food industry, water, etc.). However, the users of these kits need guarantees as to their performance.
This is why AFNOR Certification has developed a validation system for these commercial methods, the NF VALIDATION certification. This system is based on a very rigorous certification procedure to ensure that the performances of commercial kits are equivalent to those of standardized reference methods or conform to predefined performances criteria.
Due to food safety requirements, frequent microbiological analyses are required at all stages of food production. The reference methods, most often described in standards, are generally expensive in terms of labor and have a relatively long implementation time (from several days to over a week).
As far as water analysis is concerned, whether it is water intended for human consumption, bathing water or spa water (…), the requirements in terms of microbiological safety are also very strict. There is a real need to use methods that are quicker and/or easier to implement than the standardized reference methods.
To meet the requirements of analytical laboratories, manufacturers have developed and put on the market commercial methods that meet the constraints of industrial production; in other words, simpler, quicker and/or more economic than the classic reference methods. They are called “alternative analysis methods”, quick analysis methods, or more commonly “kits”.
Why certification ?
In answer to needs
The emergence of rapid microbiological testing methods in the late 1980s quickly posed the problem of the reliability of the results reported and their correlation with the results of traditional standardized methods. Following requests from economic stakeholders and public authorities, AFNOR Certification therefore created an independent certification system intended to demonstrate the reliability and performance of these new test kits, today called NF VALIDATION.
A third party system
NF VALIDATION certification confirms the analytical performance of commercial methods for a given target and a defined scope, in the fields of foodstuffs and water. This certification has held a European collective mark and an associated logo: the NF VALIDATION mark. Recognized in Europe and well-known internationally, this voluntary certification demonstrates the commitment of manufacturers to provide effective, high-quality test kits which are regularly tested by an independent body, AFNOR Certification.
NF VALIDATION certification program
NF VALIDATION, it is a third party certification governed by Certification Rules which define the procedure very precisely, from submitting the validation application to obtaining the certificate. Alternative methods are evaluated in two stages:
- Implementation of a complete validation study, by an independent Expert Laboratory qualified by AFNOR Certification, and run according to a standardized protocol
- Implementation of an audit on the production site of the kit to be validated, in order to check that the quality system in place monitoring production is effective
The certification of an alternative method relates simultaneously to the test procedure recommended by the manufacturer, the test products and equipment required for implementation of the method, and to a specified scope.
The NF VALIDATION mark is issued for a period of 4 years. In addition, certified alternative methods are monitored by means of regular audits. After this 4-year period, a technical renewal study is carried out for renewing the certification.
Why choosing alternative methods certified NF VALIDATION?
NF VALIDATION certification is a voluntary process for manufacturers, who commit to demonstrating the performances of their alternative methods by means of regular testing carried out by an independent body that is AFNOR Certification. A sure-fire way to demonstrate with complete objectivity that an alternative method meets precise quality requirements.
While AFNOR Certification performs regular controls, the manufacturer must also carry out continuous internal monitoring, controlled by audits of the manufacturing facilities. Having alternative methods certified NF VALIDATION, it is a genuine commitment to a quality oriented approach! It is this high level of control that makes NF VALIDATION Certification a truly outstanding hallmark of quality.
Bet on performance: make the choice to use alternative methods certified NF VALIDATION for your analyses!
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