ABSTRACT
ISO 9001:2015 indirectly implies the QMS should include everything that affects the ability of the organization to ensure the conformity of its products and services and the enhancement of customer satisfaction and therefore bringing environmental, health, safety or financial issues that can affect product or service quality into the scope of the QMS. This chapter examines the four requirements of clause 4.3 which replace the single requirement in the 2008 version namely: determining the boundaries of the QMS; determining the applicability of the QMS; applying the requirements of ISO 9001 and documenting the scope of the QMS. Most requirements of ISO 9001 are generic and applicable to all organizations regardless of size, complexity or the nature of its products and services. Every organization provides outputs that can be in the form of tangible or intangible products services that may process product supplied from elsewhere or services that develop, distribute, evaluate or manipulate information such as in finance, education or government.
