ISO 13485:2016 Certification

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ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organisation 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 organisations for the design and development, production, installation, servicing and sales of medical devices.

The primary objective of ISO 13485 is to facilitate harmonised 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. Organisations being certified to ISO 13485 can not claim conformity to ISO 9001.

Benefits of ISO 13485 Certification