ISO 9001 Transition
The most noticeable change to ISO 9001:2015 is its new structure. The Annex SL is a high-level structure created by ISO to provide a universal high-level structure, identical core text, and common terms and definitions for all management system standards. However, organisations should be aware that the clause 8 requirements are specific to the standard being addressed, and that for other clauses there may be differences in the requirements which should be incorporated into any integrated management system.
For ISO 9001:2015 the main changes are: An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach, fewer prescribed requirements, less emphasis on documents, improved applicability for services, a requirement to define the boundaries of the QMS, increased emphasis on organisational context, increased leadership requirements and greater emphasis on achieving desired outcomes to improve customer satisfaction.
Top management have been assigned specific responsibilities regarding leadership, roles and authorities, policy and review of the system. Whilst some of this requirement builds on the previous arrangements it should be noted that the format of the management review has changed and there are differences in the requirements for each standard. The content of the environmental policy should now refer to the new requirements to protect the environment.
The leadership clause states nine requirements common to both standards and for the Quality Management System (QMS) there is an additional requirement to promote the process approach and risk based thinking.
New requirements regarding defining the context of the organisation requires the organisation to understand the needs and expectations of interested parties and to identify external and internal issues. The technique for these two assessments is not defined, although the organisation should document their methodology.
The clause 6 planning process requires that the organisation consider the risks and opportunities associated with the needs and expectations of interested parties and external and internal issues. There is no longer the QMS “exclusion” process and organisations must determine which elements of the standard are applicable.
Plan, Do, Check, Act
The changes to the management system impact on all elements of the Plan, Do, Check, Act cycle and organisations can reduce much of the disruption to their existing system by a controlled phasing in of the changes.