ISO 13485
ISO 13485: Quality Management System for Medical Devices Introduction to ISO 13485ISO 13485:2016 is an international standard that specifies technical requirements for quality management systems
Operating in Vietnam since 1998 as a representative office of QMS Certification Services (Australia), QMS Vietnam was officially established in August 2001. It is a member company of the QMS Australia Certification Group, providing assessment and certification services for management systems according to international standards to clients in Vietnam, Laos, Cambodia, and currently expanding into Japan.
Since July 2022, in the context of rapid globalization and the increasing number of standards to comply with, QMS Vietnam has partnered with MS Certification Services to further expand its assessment scope in alignment with international standards, aiming to bring greater value to businesses in Vietnam and across the region.
Certificates are recognized by JAS-ANZ (Australia and New Zealand) and/or IAS (USA) – both members of the IAF (International Accreditation Forum). All certificates are issued under a globally unified accreditation system.
With thousands of clients across various industries worldwide, QMS has established its reputation as a trusted certification body.
In addition to a team of seasoned experts, QMS builds strategic partnerships with field specialists, authorities, government bodies, trade organizations, and associations, ensuring broad and insightful system assessments.
Delivering more than just certification, QMS provides meaningful insights and practical value to help businesses improve and grow.
Trusted Quality Certification Organization



























ISO 13485: Quality Management System for Medical Devices Introduction to ISO 13485ISO 13485:2016 is an international standard that specifies technical requirements for quality management systems