Clause 1 Scope vs clause 4.3 Scope of QMS

Answer:

Clause 1 Scope of ISO 9001:2015 explains to what kind of companies the standard applies in terms of size, type of business, type of product or service, etc. On the other hand, the clause 4.3 defines requirements for organization to define scope of its QMS (Quality Management System).

Clause 1 does not have any requirements for the QMS, it just explains to what kind of organizations the standard can apply and clause 4.3 contains actual requirements of the standard and these requirements will be audited during the certification audit. For more information, see: How to define the scope of the QMS according to ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/