ISO 13485 stipulates requirements for a quality management system for the design and development, manufacturing and servicing of medical devices.
It can also be used to assess the organization’s ability to meet customer and regulatory requirements.
A Certification body applying for ISO 13485 accreditation must conform to ISO/IEC 17021, MD9 and other additional International requirements as detailed in Specific Requirements for Accreditation for MDQMS Scheme.
MDQMS is an specific standard for medical device industry which fulfils specific needs related to production of a particular medical device such as production control, quality management & regulatory compliances. The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems.
Certification Bodies interested to apply for an Accreditation scheme for MDQMS can send an email at [email protected]