ΕΝ ISO 13485:2003 includes the requirements for implementing a quality management system for medical devices. The standard is applicable by all organizations that design, manufacture and sell medical devices. Its structure as well as its requirements is very similar to that of ISO 9001:2008 standard for quality management systems.
Their main differences are the requirements for keeping specific records for each product, the risk management in all process stages, the record keeping for infrastructure maintenance, the documented procedures for the work environment, the service provision, the customer feedback as well as for informing any interested parties.
The implementation and certification of a quality management system according to ISO 13485offers, among other, the following benefits:
- Safe products
- Fulfillment of legal requirements
- Services/products of higher quality
- Satisfied customers
- Internal processes control and continuous improvement