In its history, ISO 9001 has seen its share of changes, some significant and others less so. The ISO 9001:2000 version was the most significant change by any standard, as it moved to the process-based approach and led the way for all standards. ISO 9001:2008 saw less significant changes that focused more on harmonization across standards and terminology.
Now ISO 9001:2015 is in Draft and offers some new changes, not a revolutionary as the 2000 version, but significant in its addition of new requirements. The ISO 9001:2015 extensive revision will address global and technological changes in the marketplace. The proposed structure of the ISO 9001: 2015 revision would be as follows:
- Scope
- Normative references
- Terms and definitions
- Context of the organization – Scope and expectations for the management system.
- Leadership – Management commitment, policy, roles, responsibilities, and authorities.
- Planning – Risks and opportunities, and objectives and plans.
- Support – Resources, competence, awareness, communication, and documented information.
- Operation – Operational planning and control.
- Performance Evaluation – Monitoring, measurement, analysis, evaluation, internal audits, and management review.
- Improvement – Nonconformities, corrective action, and continual improvement.
Other Revision Details include:
- Revision to the 8 Quality Management Principles (QMPs) are expected to take place.
- Voice-of-the Customer (VOC) and Risk Management were the largest entries voted upon to be incorporated into the future 2015 version.
- Risk management, identification and mitigation were identified as lacking in many company’s current quality systems.
- General wording changes
- For example, using the term ‘documented information’ to replace references to ‘documentation’ and ‘records’.
- The text requires no specific requirements for ‘preventive action’.
- Making clear that this is because one of the principal purposes of any management system as a whole is to act as a tool for preventing non-conformity in the first place, ‘preventive action’ may still yet be included in the final revised version of ISO 9001.
- The ISO Technical Management Board has also adopted a standardized format and common-core text for use in all new and revised ISO management system standards.
- Expected to promote greater ease of use for organizations that want to integrate the requirements of multiple standards such as ISO 9001, ISO 14001 and ISO 18001 into a single, coherent system.
The ISO 9001 Revision is currently in the Committee Draft Stage. This stage is the first consultation in the revision of an ISO standard. During this stage, the countries (ISO members) that are participating in the development of the standard can comment on the document. These comments drive the ongoing process, leading to the development of a Draft International Standard which will then be open to public comment. This stage will likely take place during the first half of 2014. Once the draft has been finalized and accepted, it is published. This is likely to be by the end of 2015. If you are already using ISO 9001:2008, upon the revision’s publication, there will be a transition period (typically two years) before ISO 9001:2008 officially becomes out of date. SRI will keep its clients posted as the new version progresses.