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, IAF MD9 and other additional International requirements as detailed in Specific Requirements for Accreditation for MDQMS Scheme.

Certification Bodies interested in applying for the Accreditation Scheme can request the application form through the following link: Application Request