So far the templates have been helpful but have a question about ISO 13485:2016 clause 4.1.1
"The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirement:
My company manufactures and distributes...so exactly what am I documenting and how do I present it in good form?
I understand your answer in relation to the company's employees and their roles, but the clause is asking in regard to the company's role/s in the realization and supply of the medical device, such as a manufacturer, distributor, authorized representative, importer. How do present this?