What is ISO 13485 standard?

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations certified to ISO 13485 can not claim conformity to ISO 9001.

Why is ISO 13485:2016 important for your organisation?

These days, medical device manufacturers often insist that their suppliers and service providers are certified to ISO 13485 as a pre-requisite for doing business. ISO 13485 certification is therefore an increasingly important differentiator for organisations looking to improve their marketability.

Whilst the primary objective of ISO 13485 certification is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence it gives patients and other stakeholders through its implicit promise of quality, consistency, and continuous improvement.

Benefits of ISO 13485 standard

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations