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ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Controls in the work environment to ensure product safety. Focus on risk management activities and design transfer activities during product development.

First published in March 1999 and revised in 2002 and there are now over 25,000 certificates were issued. Is an ISO Technical Specification, which aligns existing US, German, French, Japanese, and Italian automotive quality system standards. Is a more process-based approach that requires stricter controls on each individual manufacturing process. In addition, it also specifies development of a quality managemen.

It is based on and is intended to supersede the earlier British Standard, BS 15000. However, concerns are increasingly being raised about IT services, both internal and outsourced, not aligning with the needs of businesses and customers. The standard was first published in December 2005.

However, Market research is a global industry and users of research need the reassurance that work, in different countries, is carried out to common minimum standards. A need was identified to take the process further and develop an international standard so that common minimum standards are set across countries and the various national standards become homogenised.