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.
For medical manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively also should have a properly implemented and maintained quality management system (QMS). To satisfy these conformity and QMS needs, many manufacturers are discovering the benefits of working with a third-party testing company.
Your management system’s conformity with ISO 9001, ISO 13485, ISO 14971, or ISO14001 can help your company open doors to untapped domestic and international business opportunities, and reap the benefits of: