The most important changes in the upcoming ISO 9001:2015 standard are:
More emphasis on leadership
ISO 9001’s coverage will further extend to top management’ understanding of its business environment (including social, cultural and regulatory) and its internal strengths and weaknesses. This results in the quality management system getting more integrated into operational processes and that the policy and objectives are compatible with the strategy of the company, and top management more involved in ISO 9001.
New focus on risk management
The 2015 version of the standard introduces a new clause on risk management (clause 6.1 “Actions to address risks and opportunities”) which built upon the previous section on preventive action.
Clarifications on objectives, measurement and change
The requirements regarding quality objectives will be more detailed. However, this is mainly clarification of existing requirements in the 2008 version rather than new requirements.
More emphasis on communication and awareness
The two new clauses 7.3 “Awareness” and 7.4 “Communication” will place further emphasis on these two areas.
Fewer prescriptive requirements
The 2015 version will have less prescriptive requirements, including less requirements on documentation. For example, there won’t be explicit requirements for “quality procedures” and a “quality manual”. If this will have any practical effect on ISO 9001 documentation will have to be seen as we get closer to the publication of ISO 9001:2015. Also, the role of “Management Representative” is no longer required; instead, the same responsibilities will simply last with top management. Again, if this will have any practical effect will have to be seen.
The structure of the standard will undergo some changes to reflect the above described changes. The new standard will likely be structured as follows:
Clause 3: Terms and definitions