Context of the organisation
Annex SL has introduced two new clauses relating to the context of the organisation, 4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties.
Together these clauses require the organisation to determine the issues and requirements that can impact on the planning of the quality management system and can be used as an input into the development of the quality management system.
Although there is now reference to determining the requirements of relevant interested parties there is no new requirement to ensure goods and services meet the needs and expectations of external parties other than those already identified in ISO 9001:2008, i.e. customers, regulators, etc. Such a change would require a change to the scope of the standard which is not permitted by the design specification for the revision.