25 years after the implementation of ISO 9001 the necessity of providing a new quality management system (QMS) arose. Experts, responsible for ISO 9001 development, began with the official work on revising ISO 9001 and implementing the new QM principles. This approach is considered as a milestone, a new era in the evolution and development of quality management by many renowned specialists. All the intensive work resulted in the revised standard ISO 9001:2015, published on 23 September 2015 by ISO. The aim and the main purpose of the standard have not been changed, whereas core terms and the structure were accordingly modified to enable the standard to interweave simply with various international management standards.
The new version of the standard focuses mainly on (improving) performance and is rather less prescriptive than previous versions of the standard. This was possible to achieve by merging the process approach with risk-based thinking and utilizing the Plan, Do, Check, Act cycle at all levels in the organization.
The key changes of the standards include:
- emphasizing the importance of creating a management system suited to particular needs of a given organisation;
- requiring for those at the top of an organization to be accountable and involved, harmonizing quality with broader business strategy;
- consolidating the ubiquitous risk-based thinking to make the entire management system a reliable preventive tool, encouraging continuous improvement;
- overriding the rigidness of requirements for documentation, providing the high level of freedom to an organization that can now decide what documented information is important for it and what format documented information should be in;
- interaction with other crucial management system standards by using a common core text and structure.