Jerome Industries just received its ISO 13485:2003 certification. This certificate demonstrates our ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Jerome Industries' ISO 9001 certification has been upgraded to the ISO9001:2008 standard. The upgraded standard brings with it new challenges that will allow us to better perform as a vendor. ISO9001 is a big part of the way we build our reliable product. We are serious to our commitment of quality and it shows with our recently upgraded UL ISO9001:2008 certification.
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