Element 12: What is the…

Element 12: What is the definition for external service providers and suppliers - does this mean that communication requirements that applied to essential providers in Element 13 will apply to any vendor/contractor used, even one time?

Element 16: Define an exception report

Element 20: Adding the Quality Management Policy seems redundant to the Management Review - the commitments of a policy are embedded throughout an operational plan. What is the purpose of identifying it here? Language is unlikely to change to a policy year over year, or where commitment to the policy is evident.

Element 21: Missing an "of" for PLAN c) ; identification and implementation (OF) preventive actions...
Change in this language to prevent occurrence of non-conformities vs previous of potential does not help in defining differences between opportunities for improvements and preventive actions. Suggest definition of preventive action.