ISO 13485 certification
ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for organizations involved in one or more stages of the life-cycle of a medical device and describes a process approach in terms of the design, safety and quality.
An ISO 13485 certification:
- Shows that an organisation has successfully met the requirements of this standard. In addition to facilitating supplier validation, this certification is increasingly considered to be the basis for market authorisations of medical devices, including CE and UKCA marking.
- Evidences a manufacturer's commitment to quality by the objective assessment of products, processes and services.
- Documents compliance according to the relevant standards for manufacturing of medical products.
- Meets major industry requirements from legal manufacturer's through to component manufacturer's feeding into the pipeline.
- Can be delivered in combination with other schemes such as MDSAP, CE marking and/or UKCA marking through DEKRA's one-stop approach to medical service delivery.