Element 1 - A Quality Management System
The most crucial element of the standard is implementing and maintaining a quality management system. The requirements for employing an effective QMS must be determined by the authorities. Besides, a risk-based approach to timely control the procedures is required too. The quality management process must work in a sequence. The interaction between the procedures is to be monitored, tracked and evaluated timely.
Element 2 - Management Responsibility
The second element is management responsibility or leadership and commitment. In terms of responsibilities, authorities should do the following –
- Establishing and communicating high-value quality policies
- Communicating the necessity of accomplishing clauses
- Ensuring quality objectives
- Performing reviews
- Ensuring the availability of relevant resources
Element 3 - Resource Management
In terms of resources, a company needs to acquire and maintain infrastructure, contamination control, human resources, technical element, and the work environment.
Element 4 - Product Realization
Product realization encompasses the design and implementation of quality requirements for the devices. The management must outline the work environment and define the process and the infrastructure. Also, employee qualification and training should be reviewed by the leaders as well.
Element 5 - Measurement, evaluation, and improvement
The last element is demonstrating conformity. The management must be able to ensure that all the required measures have been taken to adhere to the regulatory terms and conditions.
