ISO 13485 於 2016 年 2 月 25 日發佈自 2003 年以來的第一新版本，這是國際標準化組織的 TC210 技術委員會的 WG1 工作組的工作成果。這是該標準的第三個版本，考慮了監管機構和其他用戶的反饋。

DQS-HK is a subsidiary of the global management system certification leader DQS Group (德國體系認證集團), with global headquarter in Frankfurt, Germany and regional head office in Chicago, USA. With German Society for Quality (DGQ-德國質量協會) and German Institute for Standardization (DIN-德國標準化學會), and Underwriters Laboratories (UL-美國保險商試驗室) as its primary shareholders. Four major German industry associations HDB, Spectaris, VDMA and ZVEI also hold shares, since this provides an inside view of the customers' interests, as well as with experience and knowledge of their industries. DQS is one of the founders of IQNet (國際認證聯盟) and one of largest certification bodies. The group has built a global presence with more than 80 offices in 60 countries, employ more than 2,500 auditors & experts and have more than 57,000 certified sites across the globe. DQS certifications include ISO9001, ISO14001, OHSAS18001, IMS, TS16949, TL9000, ISO13485, AS9100, IRIS, QC080000, RC14001, ISO27001, ISO20000, ISO 22301, SA8000, Sedex, etc. DQS also provides supplier audit services, like Social Accountability. DQS is one of 4 CBs authorised by TfS (Together for Sustainability) to audit chemical suppliers. Besides, DQS provides management system standard related professional training service.

ISO 9001, ISO/TS 16949, ISO 14001, OHSAS 18001, ISO 45001, ISO 13485, AS 9100, IRIS, TL 9000, QC 080000, ISO 27001, ISO 20000-1, SA 8000, TfS, Sedex, ANSI/ESDA S20.20, VDA 6.3, ISO 30001, ISO 26262, Management System related Training, Internal Auditor Training

Quality, Environmental, Automotive, Medical, IT Service, ITSMS, Occupational Health Safety