ISO 13485 - quality that patients depend on

The standard is for everyone in the medical device chain:

• Medical device manufacturers
• Manufacturers of in vitro diagnostic medical devices
• Manufacturers of components and materials
• Sterilisation and packaging companies
• Importers and distributors of medical devices
• Service companies for medical equipment

The standard puts regulatory requirements at the centre: risk management throughout the life cycle (according to ISO 14971), control of design and development, process validation - for example of sterilisation - cleanrooms and contamination control, and traceability and identification of devices. Design must be planned and documented, and every step checked: verification confirms that the design outputs meet the design inputs, validation confirms that the device meets the needs of the user, and design transfer hands the project over to production. All records are collected in the project file - the first thing the auditor and the notified body ask to see.

Also required are supplier management, complaint handling and post-market surveillance, incident reporting, corrective and preventive action, technical documentation and detailed records - more documented procedures than in ISO 9001. Behind every line on the label there is a process in the system: the manufacturer’s details, the unique device identifier (UDI), the batch number and expiry date that allow the affected devices to be traced and recalled, the sterilisation method, the instructions for use and the CE marking.

Without an ISO 13485 system, a device will struggle to reach the market: the system is the basis for conformity assessment under the MDR and IVDR and for markets such as the USA, Canada and the MDSAP countries. Under the MDSAP programme, a single audit covers the requirements of the USA, Canada, Brazil, Australia and Japan. The higher the risk class of the device, the stricter the assessment - from a declaration of conformity by the manufacturer for class I devices (with a notified body involved for sterile devices, devices with a measuring function and reusable surgical instruments) to the strictest assessment for class III, covering the quality system, the documentation for each device and the clinical data.

For patients and doctors, the system means safe devices; for the manufacturer, it means fewer complaints and recalls, smoother audits by notified bodies and regulators, and well-organised technical documentation.