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AQA International Is Now Accredited to Certify Organizations to ISO 13485

Submitted by: Dennis Gillan on Aug 04, 2011 at 5:09 pm Tagged with: 13485, 9001, AQA, iso, ISO14001, Medical Device, sustainability Source: AQA Press release

Columbia, SC. AQA International, LLC, has received accreditation from ANAB (ANSI-ASQ National Accreditation Board) to certify organizations to the ISO 13485 standard. The ISO 13485:2003 Standard defines requirements for a quality management system (QMS) used by the companies designing, manufacturing and distributing medical devices and associated services. The primary goal of the standard is to promote harmonization of regulatory requirements for medical device manufacturers. While being certified to 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world.
ISO 13485:2003 is based on ISO 9001 Standard and often medical device manufacturers wish to establish compliance with both ISO 13485 and ISO 9001. Now AQA International can provide registration to these standards in addition to the following: ISO 14001, OHSAS 18001, ISO/TS 16949, AS9100, AS9110, AS9120, ISO 22000, ISO 27000, eStewards, R2, RIOS, and CE MARKING.
For more information on ISO 13485 or any other certification programs please contact the Business Development Group at AQA International by calling 800-281-4384 or email Dennis Gillan at dgillan@aqainternational.com