The Standard defines the requirements for quality management system in production and distribution of medical devices and establishes specific requirements in areas specific to this field, e.g. sterilisation, technical documentation, traceability). In its structure it follows up the requirements of ISO 9001.
Due to the growing emphasis on quality management systems of manufacturers and suppliers of medical devices, in 2001 the Standard ISO 13485 was compiled, which extended on the original Standard ISO 9001 specifying the requirements for production of medical devices.
The Standard joins the advantages of the general Standard ISO 9001 and of the requirements for a specific field. It is a quality tool serving as the basis for demonstration of product conformity with EU directives.
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