Accreditation for Medical Device QMS
ISO 13485 mandates the prerequisites for a quality management system concerning the creation and advancement, production, and maintenance of medical devices. Additionally, it can serve as a means to evaluate the organization’s capacity to fulfil customer and regulatory prerequisites.
A Certification Body seeking ISO 13485 accreditation must comply with ISO/IEC 17021, IAF MD9, and other supplementary international requirements as specified in the Specific Requirements for Accreditation for MDQMS Scheme.