bioMérieux, first manufacturer worldwide to be officially recognized compliant with the ISO 11133 standard

bioMérieux is the first manufacturer worldwide to be officially recognized as compliant with the XP CEN ISO/TS 11133 standard : “ Practical guidelines on preparation and production of culture media” by AFAQ/AFNOR Certification.

Audited in July 2006 by AFAQ/AFNOR certification, bioMérieux’s Craponne production plant has now officially received the evaluation certificate of compliance.

The ISO 11133 standard concerns all laboratories which manufacture culture media for their own use as well as for commercialization. It enables laboratory test results to be more reliable by guaranteeing a minimum level of performance for culture media. It is the first agri-food standard that applies not only to laboratories but also to manufacturers.

This compliance concerns the documentation as well as scientific validation of several batches of each manufactured product. Teams from Research & Development and Quality Control at our Craponne site were involved in the process that led to the modification of 150 control techniques for the compliance of culture media, intended for agri-food testing.

bioMérieux Production and Quality Control departments were assessed according to a matrix based on several standards including XP CEN ISO/TS 11133, ISO 17025, ISO 9001 and ISO 13485. bioMérieux successfully obtained this first evaluation certificate for compliance with this new matrix established by AFAQ/AFNOR Certification.

For our customers, this recognition demonstrates that bioMérieux is constantly taking international standards into account to guarantee compliance, quality of its culture media and customers’ requirements.
This guarantee means that customers will no longer need to systematically test each batch of culture media upon receipt, representing cost savings and reinforcing their confidence in the quality of our products.