What it covers
The standard sets requirements for:
- Documented quality management processes
- Design and development controls
- Purchasing and supplier control
- Production and traceability
- Handling of complaints and corrective actions
What hospitals can ask a supplier
When buying equipment such as surgical lights or pendants, hospitals can ask for the manufacturer's quality management certificate and the scope it covers. Check that the certificate is current and that its scope includes the product supplied.
Important
This page is a general overview for planning purposes. It is not legal or regulatory advice. Always refer to the current official text of the standard or regulation and your hospital's accreditation consultant.
Frequently Asked Questions
Does ISO 13485 certify a product?+
No. It certifies an organisation's quality management system. Product safety is addressed by product standards such as the IEC 60601 series.
