Medical Device Quality Management Systems Scheme

The scheme is based on ISO 13485 - Medical devices – Quality management systems – Requirements for regulatory purposes. ISO 13485 is a management system standard established to assist organisations that needs to consistently demonstrate compliance with regulatory and customer requirements for the delivery of medical devices and related services.

ISO 13485 is based on ISO 9001; but includes some particular requirements for medical devices and excludes some ISO 9001 requirements that were determined not to be appropriate as regulatory requirements. These differences mean that those organisations certified to ISO 13485 cannot also claim ISO 9001 certification without meeting these additional requirements.

As a management systems scheme, new applicants will need to comply with ISO/IEC 17021-1:2015 – Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements.

Applicants should also pay attention to IAF MD 9:2015 Application of ISO/IEC 17021 in the Field of Medical Device Quality Management Systems (ISO 13485).

Benefits

  • Allowing healthcare professionals access to a wider range of medical devices benefits a country’s healthcare system. Accredited ISO 13485 certification is suggested for regulating medium to high risk medical devices.
  • Accredited ISO 13485 certification makes a significant contribution towards harmonizing medical device regulation.

Scheme owners

International Organization for Standardization (ISO) and International Accreditation Forum (IAF).

More information

An application pack, application form and other relevant material is not available on this site. These documents are available through our SharePoint portal. If you are a body that we currently accredit, you can access this information through the Shared CAB Portal. If you are a new applicant, please complete an application enquiry form. Once this form is submitted, the Secretariat will contact you to advise the next steps.  For other stakeholders, please submit your inquiry through the online feedback form.