Context of the organisation

external and internal issues (clause 4.1)

Clause 4.1 requires the organisation to determine external and internal issues that affect its purpose and the results of its QMS, for example market, law, technology, culture, knowledge and resources.

Tools such as SWOT or PESTLE help, but the standard prescribes none. Climate change must be considered as a possible issue since the 2024 amendment.

Calculate it

ISO 9001 Internal Audit: Clause 4 to 10 checklist with minor / major findings, actions and PDF.

Related terms

• Interested party: who can affect or is affected by the organisation (4.2)
• Risk-based thinking: considering risks and opportunities in planning