Clause 4.1 of ISO 9001:2015 QMS standard provides the requirements related to captioned matter.
The organization needs to (i) determine internal and external issues (positive and negative factors or conditions) relevant to the organization's purpose, strategic direction and that can affect organizational ability to achieve intended results or desired outcomes, and (ii) monitor and review information (data) about the determined external and internal issues (positives and negative factors or conditions).
We should have a clarity that there are many issues that can help or make easier the understanding the external context of the organization and such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local. There are many other issues that can help or make easier the understanding the internal context of the organization and such issues may relate to the organization's values, culture, knowledge and performance.
To know more on the understanding the organization and its context, please refer to the following relevant articles:
- ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues - CLICK HERE.
- Understanding the organization and its context - CLICK HERE.
- ISO 9001:2015 QMS - Understanding the organization and its context - CLICK HERE.
Best wishes,
Keshav Ram Singhal
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