ISO 13485 is a standardized quality management system. It is used by medical device producers and their suppliers and 3rd-party services that supply goods / parts of goods, and QMS based corporate services. The certification adds more requirements for the following elements in relation to ISO 9001:

• Special Procedures
• Structure
• Detectability
• Administrative tasks
• Documenting records
• Environmental control

ISO 13485 is different from ISO 9001 in that it doesn’t require the demonstration of continual improvement, but only the current implementation and maintenance of high-quality standard.

The ISO 13485 Certification demonstrates that your organization’s QMS is in compliance with Medical Device industry standards. It applies to different types of entities including medical device manufacturers, subcontractors, European Authorized Representatives, suppliers, and consulting firms among others. The current requirements are laid down under ISO 13485: 2016.

Benefits

The main benefits of ISO 13485 Certification are as follows:

• Creating controls for ensuring the safety of the products in the workplace
• Developing and building awareness of administrative requirements
• Laying emphasis on style control efforts and risk management
• Laying down requirements for the certification and documentation of clean medical device processes
• Meeting requirements for the inspection and detectability of implantable devices