ISO 9001is the world's most widely recognized Quality Management System (QMS). It belongs to theISO9000 family of quality management system standards (along withISO9004), and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the next 25 years. This is why they commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as "beginning of a new era in the development of quality management systems." As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed, however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
Some of the key changes include:
- Greater emphasis on building a management system suited to each organisations' particular needs
- A requirement that those at the top of an organisation be involved and accountable, aligning quality with wider business strategy
- Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
- Less prescriptive requirements for documentation: the organisation can now decide what documented information it needs and what format it should be in
- Alignment with other key management system standards through the use of a common structure and core text