There are three subsections to ISO 13485, Chapter 5: responsibility and authority, management representative and internal communication.
Organization Chart
To ensure that employees have defined and documented responsibilities and authorities, the organization needs an organization chart, and written and signed job descriptions. The organization chart defines the authorities as well as the interrelations of all the personnel.
Job Description
The job description ensures “defined, documented and communication” of a person’s responsibilities. For this reason it is important to have signed job descriptions, which are typically signed by the hiring manager and the employee. This delegates the responsibilities and documents their awareness, or that they have been communicated to the employee.
Independent Quality Unit
In addition, this section of the standard requires the independence and authority necessary to manage, perform, and verify all work affecting quality. In simpler terms, this is requiring that the quality unit be independent from other parts of the organization and ensuring that they have the authority to ensure the quality of product.