ISO 9001:2015 A Pocket Guide

CHAPTER 5 – CONTEXT OF THE ORGANIZATION

As described in the previous chapter, the context of the organisation is, broadly speaking, the environment in which the organisation does business, including the specific pressures affecting quality. The most tangible output of the Clause is the defined scope of the QMS. Although there is no requirement to progress through the clauses in order, this is clearly an important step early in the implementation of the QMS.

For an organisation to meet the requirements, it must be able to identify the key issues and stakeholders affecting quality. This can include the availability of resources, economic realities, customers and suppliers, legal and regulatory considerations, and so on. Although the organisation ...