Explained: Responsibility and authority in ISO 13485
In order to implement the ISO 13485:2016 requirements, the definition of authorities and responsibilities of the Quality Management System and product realization should be established.
Defined management responsibility are the following:
- Form the pyramid of decision making in the MedDev organization in order to accomplish the quality objectives
- Clearly assigning employees to processes and activities
- Identifying training and qualifications needed for each function
- Allowing the orientation within processes regarding the realization of the product, data and information, and responsibilities
- Enabling a structural sharing of information between the different members of the organization
MedDev Organizational Structure
The definition of hierarchy in the organization is the Organizational Structure. In the organizational structure are described roles, functions, and relations in the organization and demonstrates who reports to whom.
The first step in defining the authorities and responsibilities of the QMS is to define the structure: the authorities and responsibilities that will operate the processes and activities are to be mapped. Regarding the documentation of the organizational structure, there is no specific requirement. But it is recommended for organizations to include an organizational chart in the quality manual.
In the Organizational Structure, every defined role must have a job description in which will be defined its responsibilities and authorities. It is important to mention that all job descriptions must correspond to the list of processes included in the QMS.
This will ensure the effectiveness of process realization. The job description is defined as what the function does daily and organizes the list of responsibilities and authorities of this specifies the function, for example, development manager, production manager, or QM. With the job description will be covered:
- The title of the role or function is important to identify every role
- The dependence will be determined according to the organizational structure
- The responsibilities are activities that combine the function’s work and effect on the Medical Device. The definition of each realization activity must be related to a function and it should be related directly to the realization processes
- The authorities are the points and events in a process where the function is authorized to make a decision that will define the flow of the process or affect the quality of the Medical Device
- The organization will decide which external qualifications are required for the role in order for it to operate the processes
- The organization will decide which internal training and certifications are required for each function
The organization will ensure that all employees at all levels are aware of their responsibilities and authorities. The matter will be presented to each role.
For the verification of the job description at later-stage audits or reviews, documenting the definitions is necessary. The documentation of the job description may be supported in several ways: work instructions, procedures or designated documents started as job descriptions.
The interrelations between the authorities describe how a process workflows between the different authorities and between different areas in the organization. The interrelations are stated through the activities. The characteristics of the interrelations are:
- Inputs and output of the processes
- The transferring of data and information between entities
- Organizational relevance of an authority
The standard expects from the organization to determine these points, events, and requirements where an interrelation between two functions are initiated. There are activities where personnel interrelate to a nonhuman systems or two nonhuman systems communicate between themselves. When such activities may affect the product, the matter will be documented and controlled. The determination possibly will appear on the relevant procedure or work instructions, but it could be described on a designated flow chart diagram.
In some of the regulatory requirements is requested the employment of specific personnel or functions for specific activities or processes. The regulations could demand certain qualifications to be nominated and certain activities to be accepted. Top management is meant to ensure that these personnel is hired when such requirements exist.
Defining the authorities and responsibilities create documentation:
- An organizational structure
- Job descriptions
- Identification of qualifications and training needs
- Definition of interrelations
Each of the documents pointed out above will be submitted to the process of document control in the organization as required in the sub-clause Control of documents.