Overview

ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets. Having certification demonstrates your commitment to meeting your customer requirements.

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires:

• Improved risk management – through greater consistency and traceability of products and use of risk management techniques
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems
• Implementation of a quality management system with several enhancements.
• Meet regulatory requirements • Demonstrate that medical devices are produced safely