Accreditation for Medical Device Quality Management Systems

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Medical Device Quality Management Systems (MDQMS)

Accreditation for Medical Device Quality Management Systems (MDQMS)

Medical Device Quality Management System certification relates to organizations involved in design, development, production, installation, servicing and related activities for medical devices. The scheme emphasizes regulatory compliance, risk management, traceability and product safety.
A certification body applying to MBAS for accreditation under this scheme shall demonstrate conformity to ISO/IEC 17021-1 and applicable medical-device certification requirements such as IAF MD 9, MBAS accreditation procedures, applicable IAF mandatory documents and relevant statutory/regulatory requirements.
  • Application documents normally required

  • Accreditation application form for Medical Device Quality Management Systems (MDQMS).
  • General accreditation requirements and conditions for accreditation.
  • Rules and conditions for use of the MBAS accreditation symbol and accreditation claim.
  • Scheme-specific accreditation requirements for ISO 13485.
  • Applicable fee schedule and quotation acceptance.
  • Documentation checklist covering ISO/IEC 17021-1 and relevant scheme-specific requirements.
  • Key evaluation areas

  • Legal identity and responsibility for certification decisions.
  • Impartiality structure, conflict-of-interest controls and committee oversight.
  • Competence criteria for auditors, technical experts, reviewers and decision makers.
  • Audit programme management, audit duration, sampling and multi-site rules where applicable.
  • Certification decision process, certificate control, surveillance, recertification and scope extension.
  • Complaints, appeals, suspension, withdrawal and public information control.