Quality System

Singclean has established and operated the quality management system in accordance with:

1.GB/T19001: 2016 idt ISO9001:2015,

2.YY/T 0287:2017 idt ISO13485: 2016 Medical Device – Quality Management Systems – Requirements for Regulatory Purposes,

3.YY/T0316:2016 idt ISO14971:2007 Medical Device - Application of risk management to medical devices,

4.Good Manufacturing and Quality Management Practice for Medical Device,

5.Implantable Medical Device – Annex of Good Manufacturing and Quality Management Practice for Medical Device,

6.Sterile Medical Device – Annex of Good Manufacturing and Quality Management Practice for Medical Device,

7.In Vitro Medical Device - Annex of Good Manufacturing and Quality Management Practice for Medical Device,

8.COUNCIL DIRECTIVE 93/42/EEC concerning medical devices,

9.DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices,

10.EN ISO13485:2016 Medical Device – Quality Management Systems – Requirements for Regulatory Purposes,

to ensure the company has the capability to consistently provide customer with products/services which met the requirements of customer and regulatory, and is committed to continual improvement of the system so as to improve customer satisfaction.