ISO 13485:2016 (Quality Management System for Medical Devices) ISO 13485:2016, based on the ISO 9001:2008 Certification process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.

The standard strongly infers that clients should consider using ISO 9001:2008 to ensure understanding of the Process Model, definitions and other items of concern, too.

Benefits of ISO 13485 certification

• 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.

• Improved risk management – through greater consistency and traceability of products and use of risk management techniques.

• Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers.

• Proven business credentials – through independent verification against recognized standards.

• Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.