Documenting the context and risks and opportunities

1-the organization context.
2-the risk,opportunities, how to arrange that related to the others processes for documentation of the ISO 9001:2015

Answer:

Both clauses 4.1 Determining context of the organization and clause 6.1 Addressing risks and opportunities do not require documents. It is completely up to organization to decide how it will document those requirements and even is it going to document them at all. However, since they are new requirements I suggest companies to develop documented procedures for those clauses.

When developing procedure for determining context of the organization it is important to define how will be involved in determining context of the organization, what elements of the context needs to be considered, which parts of the context will be documented and how often the context will be reviewed. For more information about the context of the organization, see: How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/ also you can download a free preview of our Procedure for Determining Context of the Organization and Interested Parties https://advisera.com/9001academy/documentation/procedure-for-determining-context-of-the-organization-and-interested-parties/

In case of addressing risks and opportunities, if you decide to create a documented procedure, you will need to define again the responsibilities within this process and also methodology, criteria for acceptance and frequency of revision. For more information about the risks and opportunities, see How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/ and you can also download free preview of our Procedure for Addressing Risks and Opportunities https://advisera.com/9001academy/documentation/procedure-for-addressing-risks-and-opportunities/

The way you address these clauses will not affect the other processes but rather the results of determining context and risks and opportunities will affect the processes. For example, the risk assessment may result in actions that include development of additional work instructions or making changes in the processes to avoid nonconformities.