ISO 13485:2016 Medical Device Quality Management

ISO 13485 allows manufacturers and distributors of medical devices to set up a quality management system compliant with regulatory requirements. Risk management, design and development controls, sterilisation validation and traceability are the key topics.

The audit covers the design file, validation records, complaint and vigilance processes and supplier control. The certificate is used as supporting evidence in applications to competent authorities under medical device regulation.

• Link to risk management (ISO 14971)
• Sterilisation and packaging validation
• Complaint and vigilance records

Completeness of sterilisation, calibration and design verification records is the area most examined at audit; whether the scope includes design is written clearly on the certificate.