What is The Quality Policy (In the Medical Device industry)
The policy could be understood as a strategy or kind of a guideline. You can understand Quality Policy as an optimistic, all-embracing vision. It’s the appealing verbal picture of the future which is aspired by the MedDev company in the long term.
Practically, the Quality policy’s role is to ensure the effectiveness of the organization’s Quality Management System. Basic elements are corporate philosophy, vision, and mission.
It’s expected to say something like they are committed to providing consistent Quality Medical Devices and its components. That they are committed to their customers, meeting their specific needs, also ensuring that applicable regulatory and statutory requirements are met, through effective implementation of QMS.
5 elements of Quality Policy
By the ISO 13485:2016 standard, it should be ensured that the Quality Policy:
- is applicable to the purpose of the organization
- includes a commitment to comply with requirements and to maintain the effectiveness of the Quality Management System
- provides a framework for establishing and reviewing quality objectives
- is communicated and understood within the organization
- is reviewed for continuing eligibility.
It is established by top management and they are responsible for ensuring the Quality Policy is committed and complies with all the requirements of the organization’s QMS.
When defining the Quality Policy, all of the MedDev organization’s interests and its strategic direction should be covered. Top management should make sure that the Quality Policy can be clearly understood, easily remembered, and to inspire the employees to archive your organization’s goals.
The policy should contain the proposal of a long-term perspective that is unlikely to be impacted by market or technology.
The Quality Policy is intended to be posted throughout the company, and its role should be explained to all employees on the general orientation training. The policy can also be provided to customers, consumers and other third parties.
The Quality Policy is meant to be periodically reviewed within the framework of management reviews of the QMS. This is to ensure its continued relevance and suitability. The process for reviewing the Quality Policy should be defined in the operational procedure for Management Review.
A Quality Policy is useless and meaningless if it’s not associated with quality objectives established within a MedDev organization. If you want to know more about planning and quality objectives, read it in our next article.