Certification ensures the satisfaction of harmonized international medical device standards within Monobind’s Quality Management System

LAKE FOREST, CALIFORNIA - November 10, 2008 – Monobind Inc. has successfully finalized ISO 13485:2003 standardization demonstrating its ability to consistently deliver medical device products and services that meet customer and regulatory requirements and facilitate compliance with global regulations applicable to the IVD industry.

“We feel this achievement underscores our commitment to meeting the high levels of quality required by the medical device and pharmaceutical industries.  It is a testament to Monobind’s leadership in the IVD world and further assures customers they will receive first class products and organizational support.” Tony Shatola, Monobind QA Director.

Monobind also maintains its Quality System to ISO 9001:2000 standards ensuring the consistent delivery of products and services that meet customer requirements and achieve customer satisfaction while pursuing continuous improvement.  QAS International has registered Monobind under certificate number A2163US since 2004. Additionally, Monobind is an FDA registered establishment under 2020726. To view Monobind’s Quality Certifications, registrations and other relevant licenses, please see visit the Customer Support Area.

Purpose of ISO 1345:2003
The objective of ISO 13485:2003 is to harmonize medical device regulatory requirements for quality management systems. As a result, it includes particular requirements for medical devices and excludes some of the requirements of ISO 9001 that have been deemed not appropriate to the medical sector. Because of these exclusions, organizations whose quality management systems conform to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. Monobind has chosen to maintain both standards within its Quality Management Systems.