The ISO 9001:2015 edition features importantchanges. Nigel Croft, Chair of the ISO subcommittee that developed and revised the standard, refers to the changes as ‘evolutionary’ rather than a ‘revolutionary’.
The earlier versions of ISO 9001 were quite prescriptive in certain areas, with many requirements for documented procedures and records. In the 2000 and 2008 revisions, there was more focus on managing processes, and less on documentation.
ISO 9001:2015 is even less prescriptive than its predecessor. There is more focus on performance of the QMS processes, by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
Since many organizations may have the need for several management standards, the 2015 version is designed to be easily integrated with other management systems. The new version also provides a solid base for sector-quality standards (automotive, aerospace, medical industries, etc.), including the needs of regulators and interested parties.