ABSTRACT
Introduced as a new requirement in ISO 9001:2015 the introduction to the 2008 version did make the point that an organization's quality management system is influenced by its business environment and changes in that environment and was in effect suggesting that such influences were determined. This chapter examines the two requirements of clause 4.1, namely: determining external and internal issues; monitoring and reviewing external and internal issues. Business exists to supply goods and services to customers and economic surplus to society, rather than to supply jobs to workers and managers, or even dividends to shareholders. To develop an effective QMS it is necessary to take a wide view and understand the context of the organization system of which the QMS is a subsystem. By looking for issues that only affect the QMS, without having a broader perspective, there is a distinct possibility that significant influencing factors may be overlooked.
