Quality Systems

DiSanto Technology will deliver to you, products manufactured from our operations holding registrations as follows:

• ISO 13485-2003
• ISO 9001-2000
• FDA as a Contract Manufacturer.

In the orthopedic and spine manufacturing market ISO 13485 has become a standard that is expected from all contract suppliers. We are proud to have been one of the first contract manufacturing companies to obtain this registration. 

At DiSanto we place the highest priority on quality system development, implementation, and follow-through.

Key highlights of our quality systems are:

• All machine operators trained as inspectors.
• Inspection plans developed for all parts machined.
• Gagetrak used for all gage tracking.
• First piece and every 5th piece critical data collected.
• Key dimensions checked via CMM - 4 total CMM's.
• Customer complaint tracking/improvement program.
• Risk management assessment.
• Critical process validation programs.

ISO 13485 Certificate.pdf

ISO 9001-2000.pdf

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