ISO 13485:2016 · MDQMS
Medical Devices Quality Management Systems
A stand-alone quality management standard designed for regulatory compliance in medical device manufacturing.
About ISO 13485:2016
ISO 13485 adapts the process-based model of the ISO 9000 series for the regulated medical device environment.
While based on the Plan-Do-Check-Act model, it is more prescriptive than ISO 9001 and requires a more thoroughly documented quality management system.
Key elements
- Risk management throughout product realisation
- Design and development controls
- Traceability and record keeping
- Regulatory reporting and post-market surveillance
Benefits of certification
- Support for market access in regulated jurisdictions
- Consistent design, manufacture and delivery of safe devices
- Improved process control and efficiency
Apply for accreditation
Contact IACAB to discuss the scheme, scope and timeline for your organisation.