OUR QUALITY POLICY: ZMicro is focused on ensuring that quality is a priority in everything we do. We strive to continually improve our quality management system and seek to exceed the expectations of our customers while complying with requirements of regulatory agencies around the world.
Our quality management systems follow the guidelines established by the International Organization for Standardization (ISO). Following are testaments to ZMicro’s pursuit of excellence in ruggedized computing solutions and medical devices:
ZMicro’s ISO 9001:2015 certification indicates that we have implemented a Quality Management System (QMS) designed to meet our customers’ quality requirements while continually improving our operational processes. Our quality systems have been evaluated and certified by an authorized third party. The careful and ongoing scrutiny of our processes is the best and most objective method for improving systems and controlling the level of precision in our performance and operations.VIEW CERTIFICATEVIEW ISO WEBSITE
ISO 13485:2016 pertains to a comprehensive quality management system involving the design and manufacture of medical devices and related services. Compliance with the ISO 13485 standard also helps meet the requirements specified in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers.VIEW CERTIFICATEVIEW ISO WEBSITE
The Medical Device Single Audit Program (MDSAP) is a program that allows a single regulatory audit of a medical device manufacturer’s Quality Management System (QMS) which satisfies the requirements of regulatory jurisdictions for the following countries: Australia, Brazil, Canada, Japan and the United States.VIEW CERTIFICATEVIEW MDSAP WEBSITE
AS 9100 is an aerospace standard based on ISO 9001 quality system requirements. AS 9100 supplements ISO 9001 requirements with additional quality system requirements, which are established by the aerospace industry to satisfy DoD, NASA and FAA quality requirements.
Whether you are looking for an off-the-shelf product or a custom solution, we can help you meet your requirements. Contact us to speak with one of our solutions experts.Let’s Talk