ISO 13485
ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.
ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices.
The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems.
ISO 13485 Benefits
The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide includes:
1. Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
2. Controlled consistency of manufactured products
3. Managed productivity and efficiency, controlling costs
4. Competitive advantage and increased marketing and sales opportunities.
5. Improved customer perception of the organization’s image, culture and performance.
Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.
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