New Quality Management Standard for Medical Sector

Press release: 29 August 2003

The BSI Group has updated the existing medical device quality management standards to the new single BS EN ISO 13485:2003 to enable UK manufacturers to meet regulatory and customer demands. This quality management system allows medical device manufacturers to market their products around the world with greater confidence, as it is vital to consistently deliver safe and effective medical products within a transparent supply chain.

BS EN ISO 13485:2003 is a tailored Standard, based on ISO 9001. The primary objective of BS EN ISO 13485:2003 is to facilitate harmonising medical device regulatory requirements with an organisation's quality management system.

As a result, it includes particular requirements for medical devices and excludes some of the principles of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, medical device manufacturers whose quality management systems conform to this British Standard cannot claim certification to ISO 9001 unless their quality management systems conform to all of its requirements.

David Lazenby, Director of British Standards comments: "This is an important development in the medical sector. The new BS EN ISO 13485:2003 will provide medical device manufacturers with a stand-alone standard for quality management systems which they can use to demonstrate their regulatory compliance without ambiguity."

This latest version, BS EN ISO 13485:2003, supersedes both BS EN ISO 13485:2001 and BS EN ISO 13488:2001. There is a three-year transition period for the British Standard. During this period both the new standard and old standards will be acceptable. In the summer of 2006 the old standards will be fully withdrawn.

The new standard also helps businesses to comply with European Directives for medical devices (90/385/EEC, 93/42/EEC and 98/79/EC) in order to achieve the CE mark of approval on their products.