What is the ISO 13485 Standard?

ISO 13485 specifies requirements for a quality management system that can be used by an organisation involved in one or more stages of a medical device's lifecycle.

These include design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development or provision of associated activities.

The Standard can also be used by suppliers or external parties providing products such as raw materials, components, subassemblies, medical devices, sterilisation, calibration, distribution, and maintenance services.

Benefits of ISO 13485 Certification

Organisations in the medical manufacturing industry across the globe have experienced the benefits of attaining ISO 13485 certification. By assessing and improving internal quality management processes, your organisation will build a reputation for consistently and reliably manufacturing quality medical devices. 

The ISO 13485 tick of quality publicly demonstrates your business’s certification, providing stakeholders and consumer with confidence, helping your organisation to stand out amongst competitors.

The benefits of an ISO 13485 certified quality management system can include:

• Demonstrated commitment to quality management

• Increased patient safety and reduced product risk

• Enhanced compliance with regulatory requirements specific to the medical industry

• Improved reliability and consistency of product quality

• Strengthened stakeholder confidence and customer trust

• Improved efficiency in design and development process

• Enhanced company reputation in the medical device industry

• Facilitation of product approvals in global markets due to internationally recognised certification

ISO 13485 Certification Mark