The high-level structure and the core text established in Annex SL, Appendix 2, have introduced two new clauses related to the context of the organisation:
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
These two clauses require the organisation to determine the issues and requirements that can impact the planning of the quality management system (QMS) and can be used as input for the development of the QMS.
The stakeholder approach, considered one of the most modern corporate governance principles, is new. This approach is based on the assumption that long-term business success can only be ensured by considering the requirements of company stakeholders.
The approach has been described for many years in ISO 9004:2009, Section 4.4 “Interested parties, needs and expectations“, and has been introduced in the new standard. In comparison to “Customer Relationship Management“ (CRM), which only addresses the relationship between an organisation and its customers, the principle of Stakeholder Relationship Management (SRM) goes significantly further. It tries to balance the relationship of the organisation with all, or with the most important, stakeholders/interested parties. These could include direct consumers, suppliers and retailers and other parties along the supply chain, authorities and other relevant interested parties. As a new feature, the term “interested parties“ now also includes owners, people in an organisation, bankers and even competitors.
Although ISO 9001:2015 now points out that organisations must determine the requirements of the relevant interested parties, there is no new requirement to ensure goods and services meet the needs and expectations of these parties (with the exception of customers and authorities). Such a requirement would necessitate a change to the scope of the standard that is not permitted by the design specification of the standard.