This Standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
The newly published EN IS013485: 2003 Medical Devices Quality Management Systems. Requirements for Regulatory Purposes now includes a requirement for senior management "buy-in" as specified in ISO 9001:2000. However the primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of BS EN ISO 9001 that are not appropriate as regulatory requirements. Therefore, while BS EN ISO 13485:2003 has the same format as BS EN ISO 9001:2000 and most of the same requirements, compliance with BS EN ISO 13485:2003 does not provide conformity with EN ISO 9001:2000.
IS0 13485: 2003 Online Application Form |
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