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ISO Certification and the Medical Device Industry Part 3 – North American Standardization and Packaging

December 24, 2012

In this blog we’ll continue our look at ISO certification, and discuss the certifications possessed by NASP.

The current ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic). The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services.

Every company that has secured certification to any of the ISO standards has persevered through the efforts necessary. For most companies it is a matter of tweaks while for others it may result in a complete overhaul of systems and processes. No matter the road necessary to reach the goal the efforts are well worth the result.

NASP was certified to ISO 9002/ EN 46002 in 2001 and has continuously maintained certifications to present day that include ISO 13485: 2003 for the contract manufacturing of medical devices and  ISO 11135-1:2007 for the ethylene oxide sterilization of medical devices. The most recent recertification audit included the addition of design aspect to expand further the qualified services NASP is able to provide to our customers. NASP was able to realize the immediate benefits of securing certification through a broadened customer base by being considered for and securing contracts for products that are distributed in non-US markets. Additionally it reduced the number of and/or depth to which customers (existing and potential) conduct quality system audits. NASP also relies on ISO certifications in identifying, selecting and approving qualified suppliers for the services, materials and components integral to the NASP client base.

 

This concludes our look at the world of ISO certification, its relation to the medical device industry and its importance to what we do here at NASP.

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