Webinar On Medical devices Quality Management System Policy ISO 13485

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The Quality Policy should be the overall goal of the organization, and is written by top management in order to direct everyone in the organization as to how medical devices will be created and delivered to the customers.

This top-level policy is intended to be communicated and understood by everyone in the company, so they can all follow one strategic direction on how product development happens and how requirements will be met. Commitment to quality can then be used throughout the organization as a focus on how processes are performed, and as a guide for the quality objectives of the organization—those main improvement aims that the company plans to achieve.

Along with guiding the commitment to achieving quality objectives, the Quality Policy is a reflection of the organizational goals for providing medical devices. As such, the Quality Policy can be a filter for making decisions within the organization.

For instance, if your Quality Policy includes a commitment to meeting customer and legislative needs for the medical devices you provide, then a manager who is assessing the resource needs of their process can ask themselves: “Will changing this resource need improve our ability to meet customer and regulatory requirements?” If the answer is no, then a different decision, one that will help to meet the company’s goals, should be made.

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