BS EN ISO 13485 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can also be used by internal and external parties, including certification bodies to test an organization’s ability to meet both customer and regulatory requirements.
How does it work?Specifying the requirements for a quality management system, BS EN ISO 13485 helps organizations to provide medical devices and related services that live up to the expectations of customers and regulatory bodies. Its main objective is to deliver harmonised medical device regulatory requirements, and provide quality management system specifications that complement the technical aspects of related products and services.
What is new?BS EN ISO 13485:2003 replaces BS EN ISO 13485:2001 which has been withdrawn.
Who should buy it?Organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.
Why BSI?We are global, we’re independent and we’re a trusted service provider to 80,000 businesses. We operate in 147 countries and are the number one certification body in the UK and US. We created 85% of our portfolio because we know standards and we know your business. We’re leaders and we can make you one too.
