ISO 13485:2003 is an international standard pertaining to medical devices. This standard specifies requirements for a comprehensive management system for design, development, engineering and production of (parts of) medical equipment and devices. Pekago has been certificied according to ISO 13485:2003 since June 27, 2011. ISO 13485:2003 is a stand-alone international standard pertaining to medical devices that is harmonised with ISO 9001. This ISO standard, published in 2003, specifies requirements for a comprehensive management system for design, development, engineering and production of (parts of) medical equipment and devices.
Fundamental difference compared to ISO 9001:
- focus on risk management activities and design transfer activities during product development
- specific requirements for verification of the effectiveness of corrective and preventive actions
- specific requirements for inspection and traceability for implants
- specific requirements for documentation and validation of processes for sterile medical equipment/tools
- promotion of awareness of laws and requirements pertaining to management responsibility
- production control measures to ensure product safety
The standard requires documented procedures, declarations and record keeping.
Once achieved, this will serve as a new tool for the development of components for medical equipment in accordance with a uniform and controlled process.