The context and leadership requirements

May I be highlighted by you whether clause 4 can be written in details in my Quality Manual without a separate procedure ?
Is clause 5.1.1 a new requirement? I observe that all the clause 5 and sub_clauses on leadership are basically the same except risks and opportunities that must be identified and addressed so as not to affect customer satisfaction or risks of customer dissatisfaction.

Answer:

First, requirements for context of the organization do not include documenting the context or writing the procedure. If you decide to document it, you can include it in your Quality Manual or make separate procedure, since it is not requirement of the standard, you are free to do it in any way that you find the most suitable. For more information, 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/

As far as clause 5.1.1 is concerned, there are no new requirements compared to the previous version o the standard. For more information, see: How to comply with new leadership requirements in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-comply-with-new-leadership-requirements-in-iso-90012015/