ISO 13485:2003 – Medical Devices Quality Management System
ISO 13485 is based on the ISO 9001:2000 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realisation
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems.
Benefit of ISO 13485:2003
• Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
• Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
• Improved stakeholder relationships – including staff, customers and suppliers
• Legal compliance – by understanding how statutory and regulatory requirements impact the organisation and its customers
• Improved risk management – through greater consistency and traceability of products and use of risk management techniques
• Proven business credentials – through independent verification against recognised standards
• Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.