Quality system

Sistema Qualità




Coronati Consulting is an ISO 9001 and ISO 13485 certified company that is from over 20 years in the field of consultancy, especially for the of the Quality Management System of companies in the medical and biomedical sector that shall follow the standards:

-ISO 9001 (generali)

-ISO 13485 (medical devices)

The documentation of the entire Quality System is made starting from prepared models which are customized in the Company with the collaboration of company managers.

The consultancy is carried out by personnel with specific preparation and experience acquired in multinational companies in the biomedical sector and subjected to the comparison of the most important Notified Certification Bodies worldwide.

Consultancy activities consist of:


-Creation of all the guide and registration documents of the company Quality System (company organization chart, job descriptions, forms, management procedures, technical procedures, validation master plan, technical files, quality manual)


-Internal audits of all company functions and suppliers


-Assistance during the audit of the Notified Body


-Identification and interpretation of all applicable standards


-Assistance during the design of new processes and new medical devices


Preparation of technical reports

Quality system

CE marking

Free sale certificate (FSC)

CE conformity

Registration and repertory  (RDM)