Is Mesa Laboratories ISO certified?
Mesa’s Medical Division is qualified to the ISO 13485/13488 standard and is registered as a Medical Device manufacturer with FDA, under registration number 1720309 and with Canada (CMDR). Appropriate portions of this rigorous quality control system are also utilized by the DataTrace Division. The DataTrace Compliance and Certification (form 339) certifies not only the Software Validation but also the FDA-based quality system for DataTrace and the NIST-traceable calibration system. Unlike an ISO certificate, it gives more detail about our quality system. Our Quality Assurance Manual is designed to substantially comply with all the criteria of ISO 9001. This document is revised to keep it current with new products, changing requirements, and technologies.
