Documentation for the context and risks and opportunities
Assign topic to the user
Answer:
Actually, the ISO 9001:2015 doesn't explicitly requires you to create any documents regarding context of the organization and risks and opportunities, it will depend mostly on the size and type of the organization and complexity of your processes.
My recommendation for addressing requirements regarding context of the organization and risk and opportunities is to create some documents because it is much easier when it's done for the first time and, frankly, it will be much easier to demonstrate your conformance to the requirements to certification auditor.
For more information, see:
How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/05/26/how-to-identify-the-context-of-the-organization-in-iso-90012015/
The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/
List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015//
Comment as guest or Sign in
Jan 12, 2016