accreditations & certificates

ISO 13485 is the international standard that specifies requirements for a quality management system for the production and supply of medical devices and related services. Accreditation to this standard demonstrates our ability to consistently provide medical devices that meet the highest customer expectations and regulatory requirements. ISO 13485 remains the world’s most popular standard for medical device quality management. Certification to this ISO standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there. 

The full requirements for ISO 13485 can be viewed here: https://www.iso.org/obp/ui/#iso:std:iso:13485:ed-3:v1:en 

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Accreditation to this standard demonstrates our ability to consistently provide products and services that meet the highest customer expectations and regulatory requirements. It also demonstrates our commitment to the continuous improvement of our processes. Certification to this ISO standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there.  

The full requirements for ISO 9001 can be viewed here: https://www.iso.org/obp/ui/#iso:std:iso:9001:ed-5:v1:en 

ISO 14001 is a voluntary international standard that specifies the requirements for an effective environmental management system (EMS), including how to manage environmental aspects of a business, fulfil compliance obligations, and fully address risks and opportunities. We use this standard in conjunction with our environmental policy to ensure our products and services meet established environmental performance requirements, while maintaining the quality expected by our customers and regulations. Certification to this ISO standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there.

The full requirements for ISO 14001 can be view here: https://www.iso.org/obp/ui/#iso:std:iso:14001:ed-3:v1:en 

BS OHSAS 18001: 2007 is the British standard for an occupational health and safety (OHS) management system. It helps organisations put in place the policies, procedures and controls needed to achieve the best possible working conditions and workplace health and safety, aligned to internationally recognized best practice. Certification to this BSI standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there.

The full requirements for BS OHSAS 18001 can be viewed here: https://www.bsigroup.com/en-GB/ohsas-18001-occupational-health-and-safety/ 

ISO 22301 is the international standard which outlines the requirements for the planning, establishment, implementation, operation, monitoring, review, maintenance and continuous improvement of a document management system. The processes outlined in this standard are intended to help organisations prevent, prepare for, respond to and recover from disruptive incidents. Certification to this ISO standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there.  

The full requirements for ISO 22301 can be viewed here: https://www.iso.org/obp/ui/#iso:std:iso:22301:ed-1:v2:en 

ISO/IEC 27001 is the international standard that outlines the requirements for establishing, implementing, maintaining and continuously improving an information security management system. In developing such a system, organisations are able to improve their risk management processes and thereby better preserve the confidentiality, integrity, and availability of information. Meeting the requirements of ISO/IEC 27001 is intended to give customers and potential partners the greatest confidence that information risks are adequately managed. Certification to this ISO standard has been achieved via Hutchison Technologies office in Dongguan City, China, and applies exclusively to operations and processes carried out there.  

The full requirements for ISO/IEC 27001 can be viewed here: https://www.iso.org/obp/ui/#iso:std:iso-iec:27001:ed-2:v1:en