Revisions to ISO 9000 prompts changes to ISO 13485, the standard specific to medical device manufacturers.

Global quality management standards had their beginnings in the late 1980s with the publication of the ISO 9000 series of documents developed by ISO/Technical Committee (TC) 176. The intent of these documents was to provide an internationally recognized set of quality management standards for all industries. The ISO 9001/2/4 standards were adopted in Europe as an analogous series of standards, EN 29001/2/3, and subsequently as EN ISO 9001/2/3.

It became clear that at least one specific segment of industry required special consideration regarding quality management standards—the medical device industry. The reason for this unique need stemmed from the fact that manufacturers of medical devices are subject to additional requirements from various national regulatory bodies. In order to produce standards that also met such regulatory requirements, a supplemental set of European quality management standards, EN 46001/2/3 series, could apply directly to the medical device industry in such a way as to comply with regulatory requirements.