Medical Device QMS

ispectionBodies

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.

Documents for Accreditation

  • Certification Bodies interested to apply for an Accreditation scheme for MDQMS can send an email at info@uafaccreditation.org demanding for following Application documents.
  • Accreditation Application for Medical Devices Quality Management System: UAF-APL-CAB-MDQMS
  • General Criteria for Accreditation Requirements: UAF-GEN-CAB-01
  • General Criteria for Conditions for the Use of UAF Accreditation Symbol: UAF-GEN-CAB-02
  • Accreditation Requirements for Medical Devices Quality Management System:UAF-CAB-MDQMS
  • Applicable Fees: UAF-CAB-MS-FEES
  • Documentation Checklist as per ISO/IEC 17021-1 and IAF MD9
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