Accreditation for Medical Device QMS Scheme in accordance with ISO 13485

Accreditation for Medical Device QMS

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 to apply for an Accreditation scheme for MDQMS  can send an email at demanding for following Application documents.

  1. Accreditation Application for  Medical Devices Quality Management System: UAF-APL-CAB-MDQMS
  2. General Criteria for Accreditation Requirements: UAF-GEN-CAB-01
  3. General Criteria for Conditions for the Use of UAF Accreditation Symbol: UAF-GEN-CAB-02
  4. Accreditation Requirements for  Medical Devices Quality Management System:UAF-CAB-MDQMS
  5. Applicable Fees: UAF-CAB-MS-FEES
  6. Documentation Checklist as per ISO/IEC 17021-1 and IAF MD9.

Prior to demanding Application Set, Please read Specific Accreditation requirements for Certification of Medical Device Quality Management System in accordance with ISO 13485 and other guiding documents in the publication area.