The organization has a process for identifying internal and external issues that are relevant to its purpose and QMS. This can be implemented e.g. through strategy work or by utilizing SWOT (for internal issues) or PESTLE (for external issues) analysis.
Process includes describing how the relevant issues are followed and how they generate risks, changes, improvements or tasks to the management system, when they are relevant for properly reacting to the identified external and internal issues.
Examples of relevant internal issues might be:
- issues related to values
- issues related to culture
- issues related to organizational structure / governance
- issues related to organizational knowledge
- issues related to performance of the organization
Examples of relevant external issues might be:
- new relevant legislation
- new relevant technological developments
- actions by competitors or changes in competitive environment
- new market opportunities
- new economic opportunities
