Section 4.3 ISO 9001:2015

Examples of external issues can be, for example, market factors such as competition, market leader trends, or supply chain relationships. Other examples can be statutory and regulatory factors. Operating in certain areas can require certification due to regulation or competition.

Examples of internal issues can be, for example, operational factors such as process or production and service provision capabilities. For example, an organization can decide to certify just part of the production facilities. 

The following material will provide you information about the scope:

- ISO 9001 – 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/
- Free webinar – ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/
- free online training 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/