We are currently 9001-2008 registered and just had our surveillance audit for upgrading to 9001-2015. In reading/digesting the new Standard, it’s my opinion that each element is a matter of interpretation. It’s not black or white, it’s gray. Example: Risks and Opportunities. I was looking for additional input to help solidify my opinion of “interpretation”.
The standard requirements are not too specific in order to enable companies to adapt the QMS to their own needs, but it doesn't mean that each requirement can be interpreted in different way. For example, regarding risks and opportunities, the organization needs to identify and address risks and opportunities emerging from the context of the organization related to quality of products and services, objectives and customer satisfaction. But, the standard allows organization to choose whether to document a procedure, use apply some risk assessment methodology and rec ords its risks and opportunities.