ZebraSci – an ISO 17025 Laboratory

“I am happy to announce ZebraSci has successfully completed our ISO 17025:2005 certification audit with no issues! I am proud of all our team members who worked so hard during the past year to implement and support our QMS and contract laboratory testing business,” states Rob Schultheis, President of ZebraSci, “I look forward to continuous improvement initiatives that will allow us to better support our growing client list of medical device, combination products and drug delivery device manufacturers.

Accreditation to ISO 17025 is the highest level of competence a testing laboratory can demonstrate – validating our testing programs and our internal calibration and quality procedures. ISO 17025 laboratory accreditation ensures our clients’ that laboratory training, test method validation, NC/CA/PA procedures and equipment calibration and maintenance programs are in compliance with contemporary standards.

“The specialized testing programs for drug delivery devices and combination products that our laboratory performs, are not routinely assessed by ISO 17025,” states Michael Martins, Laboratory Manager, “The assessment was a learning experience for our team as well as our assessor.”

ZebraSci routinely performs all the required elements of the ISO 17025 standard; we are assessed annually by A2LA for verification and in addition to internal quality requirements, we participate in proficiency testing (PT) programs as an on-going commitment of our laboratory’s compliance. ISO 17025 accreditation reaffirms ZebraSci’s technical competency and capability to produce precise and accurate test data that our clients can rely upon to meet regulatory requirements for medical devices, combination products and drug delivery devices.

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