These 3 sections below represent the greatest changes made to the 2008 version. ISO 9001:2015 could have been labelled a business management system as it takes the concept of quality management to another level.
This section is completely new and aims at analyzing the context of the organization by identifying the expectations of interested parties, internal and external business issues and strategic direction, as it applies to the QMS.
This section has been reinvigorated by stressing and detailing in a bigger way the involvement of Leadership (term replacing Top management). With the new version, it is impossible for Leadership to “delegate and disappear” when it comes to QMS’ responsibilities. High-level management processes associated with section 4 requirements can only be performed by Leadership.
Most of the planning requirements of the standard have been concentrated in this section, as opposed to be distributed throughout, as per the 2008 version. Planning requirements must take into considerations risk-based thinking, which is a huge departure from the 2008 version. For instance, in the 2008 version, you can have a process that deliver its intended outcome and everything was assessed to be fine in process performance. In the 2015 version, you must look at the risks and opportunities, such as how does it fare with competition? Does it meet the expectations of interested parties? Will the business line itself be sustainable in the marketplace or should we look at emerging opportunities? To meet the requirements of this section, you must analyze documents like environmental scan, SWOT analysis, strategic planning and objectives and identify what is at stake for the QMS in your company or organization. It is a daunting task as most companies or organizations have kept high-level management processes inside the boardroom, now they must incorporate high-level knowledge to their business processes. It is a change in paradigm for many.