Scope clause

ISO 9001:2015 clause 4.3 is about the scope of the quality management system (QMS). Once determined the scope an organization may find that some clauses may be not applicable. For example, an organization may have two kinds of business:

1. Manufacturing products that are sold to consumers through stores
2. Manufacturing products according to client’s instructions and with client’s materials

If the QMS scope is only about business 1, then clause 8.5.3 is not applicable. Please check ISO 9001:2015 Annex A.5 about applicability

The following material will provide you more information about scope and exclusions:

• 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/
• What clauses can be excluded in ISO 9001:2015? https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
• Free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope -
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/