ISO13485

January 2023

StatLab Medical Products, a leading developer and manufacturer of medical diagnostic supplies and equipment for use in anatomic pathology, announced that it has completed ISO13485 recertification by BSI. Not only has recertification been achieved, but the audit revealed zero findings—that means the StatLab team received a perfect score in this rigorous certification process.

Why is ISO13485 certification important, and why is a perfect score on a recertification audit something to be proud of? ISO13485 is a global recognized quality standard, measured and assessed by a third party as proof of high-quality standards and processes to support those standards. ISO13485 gives consumers confidence.

ISO13485 recertification audits are completed every three years, and are more thorough in nature than the annual surveillance audits completed.

The recertification results and score represent the effort that StatLab has put into increasing both quality standards and processes over the past 24 months. 

 

 

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