What is ISO
ISO is a standards setting body representing over 150 countries. Standards are established for topics that are proposed by member countries. Over 10,000 ISO standards have been established since ISO was founded in 1946. Quality Systems were addressed by the creation of ISO 9001 in 1989 and Quality Systems for medical products by ISO 13485 in 2003.
What is ISO 9001
ISO 9001 is a set of requirements defining the minimum practices for a Quality System covering design, production, services and infrastructure. 9001 is a generic set of requirements that are applicable to any industry. Mercury has adapted the 9001 requirements to fit our business.
What is ISO 13485
ISO 13485 is a set of requirements for companies that design and manufacture medical devices. The requirements are very similar to 9001 with some specific additions for medical product needs. Regulatory agencies in Europe expect ISO 13485 registration before they approve a medical product for sale.
Is Mercury ISO registered
Yes. Mercury's Quality System has been audited and is registered to the following standards:
ISO 9001:2000
The scope of Mercury's Quality System is for the design, manufacture, and support of computer hardware, software, systems, and documentation of our 199/201 Riverneck Rd., Chelmsford, MA (Headquarters); 2105 South Bascom Ave, Campbell, CA (ASBU); 14160 Dallas Parkway, Dallas, TX (DBU Western Region); and 1800 Alexander Bell Drive, Reston, VA (DBU Eastern Region) facilities.
ISO 9001, ISO 13485, CDMCAS and MDD
The scope of the Quality Management System for Mercury’s Life Sciences within the CIV business unit covers four sites for the design/development, production, service, and sale of software and system solutions: 199 Riverneck Road, Chelmsford, MA (Headquarters); MCS GmbH, Lepiusstr. 70, 12163 Berlin, Germany; MCS GmbH, Wuerzburger Str. 197, Fuerth, 90766, Germany; MCS GmbH, Bussard Street, Fuerth, 90766, Germany.