Determining scope of QMS considering context of the organization

Answer:

The requirements from clause 4.3 state that you need to define the scope of your QMS according to the internal and external issues which means that you need to define context of your organization and why you want to implement the standard and to align the scope with your own needs as a company. For example, if you want to apply to tenders with only one of your products, you can cover only one production line with the scope of the QMS and save money on certification because you will only certify this production line and not entire organization.

The same reason is behind the consideration of interested parties. For example, your customer might require you to implement ISO 9001 because he buys one of your products so you can again cover with the scope only this production line to save time and implement the standard faster and meet customer requirements.

You do not need to explain or justify why you decided to go with the scope the way you decided but you must define the scope considering all element of your organization context and you need to document the scope of QMS. 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/