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ISO9001:2015

Astrodyne TDI Production Facilities are certified to Quality Management Standard ISO9001:2015. In addition, various facilities have additional certifications to meet the needs of the customers and their end product.

ISO 13485:2003

ISO 13485:2003 specifies requirements for a quality management system with the focus on the Ability to provide medical devices that consistently meet customer and regulatory requirements which are applicable to medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. As a result, each location with ISO 13485 certification also maintains a separate ISO 9001 certificate.

Certification Facility Registrar Certification Number Date Issued
ISO13485 Shenzhen, China DQS 50050287 MP2016 May 4, 2018 ISO13485 2016 EN
AS9100D Hackettstown, NJ Sep 20, 2018 Certificate for AS9100
ISO 13485:2016 Hackettstown NJ Jun 26, 2018 Certificate for ISO 13485 2016
ISO9001 : 2015 Shenzhen, China TUV NORD 04 100 000090 May 4, 2017 ISO9001 2015 CERT
Air Agency Certification Hackettstown, NJ DOT FAA 7TDR880B Jan 23, 2014 air-agency-certificate
EASA.145.6454 Hackettstown, NJ EASA 7TDR880B Dec 11, 2018 EASA.145.6454 Certificate
ISO9001 Kunshan, CHINA SGS CN05/00125 Mar 1, 2018 ISO 9001-2015 China
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