Since its first publication ISO 9001 went through several revisions to keep it up-to-date and to consider the changing environment and stakeholder expectations. It was first published in 1987, containing a set of requirements grouped in 20 elements for quality assurance systems. The first revision followed in 1994, introducing some minor changes like the distinction between corrective and preventive action. The revision in the year 2000 introduced a completely new concept, abandoning the element-based requirements and introducing a Quality Management Model based on a process approach. Again a revision followed in 2008 with very few changes without adding or changing requirements.
ISO 9001 is the most successful standard for management systems in the world. While in 1995 only 127,000 organizations have been certified according to ISO 9001, this number increased in 2013 to more than 1,100,000 certificates in 180 countries.
Despite the innumerous benefits obtained through an implemented quality management system based on ISO 9001 (e.g. error prevention, reduced costs through improved and more efficient processes, minimization of business risks, increased customer satisfaction, trust and reputation), a new revision of the standard was necessary again to assure that the standard is still relevant and adequate in an always faster changing world. The increasing diversity of ISO 9001 users had to be considered, not having any longer only manufacturing industries but more and more service industries and other kinds of organizations.
It was also necessary to verify the impact of new developments in knowledge and technologies which changed during the last years, as well as broader user interests and changes in industry. In 2010 and 2011, ISO conducted an extensive web-based user survey, asking about the need for a revision and the future needs and interests of the standard users. The answers have been evaluated and the majority asked for changes and a review of ISO 9001.