ISO 13485 is a medical devices standard, not a product standard. The standard is based on ISO 9001 and organised in the same way using the same numbering and most of the requirements directly from ISO 9001. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements, applicable to medical devices and related services. The primary objective is to facilitate harmonised medical device regulatory requirements for quality management systems.
What are the benefits to me and my organization?
- Demonstrates your ability to supply medical devices and related services, that meets customer expectations and complies with regulatory requirements
- Evaluates how well your organization is able to meet customer expectations and comply with regulatory requirements
How can it help me to gain business?
- Effective management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world
What are the internal benefits for my business?
- Establishes a management system that is oriented towards the design, development, production, and installation of medical devices and related services